ClinicalTrials.gg
RecruitingNCT04728893Updated Oct 27, 2026

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

A Phase 2 interventional study of Nemtabrutinib in Hematologic Malignancies, Waldenstroms Macroglobulinaemia and Non-Hodgkins Lymphoma, sponsored by Merck Sharp & Dohme LLC. Recruiting at 121 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 7 months later.
Updated Oct 27, 2026Site recruiting status changed1 site added+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
490
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

Read the detailed description

This study will be performed in 2 parts: Dose Escalation and Confirmation (Part 1) and Cohort Expansion (Part 2). Following determination of the recommended phase 2 dose (RP2D) in Part 1, the study plans to proceed with Part 2 using 8 disease-specific expansion cohorts (Cohorts A to H).

02

Conditions studied

  • Hematologic Malignancies
  • Waldenstroms Macroglobulinaemia
  • Non-Hodgkins Lymphoma
  • Chronic Lymphocytic Leukaemia
03

In context

Hematologic Neoplasms

1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.

This study's planned enrollment of 490 is above the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.

Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Has an (ECOG) performance status of 0 to 2 within 7 days before C1D1 (the first dose of study treatment)
  • Has a of at least 3 months, based on the investigator assessment
  • Has the ability to swallow and retain oral medication
  • Participants who are surface antigen (HBsAg)-positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
  • Participants with history of virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  • Has adequate organ function
  • Male participants agree to refrain from donating sperm and agree to either remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle OR agree to use , during the intervention period and for at least the time required to eliminate the study intervention after last dose of study intervention
  • Female participants assigned female sex at birth who are not pregnant or breastfeeding are eligible to participate if not a participant of (POCBP), or if a POCBP they either use a contraceptive method that is highly effective OR remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle during the intervention period and for at least to eliminate study intervention after the last dose of study intervention
  • Participants with (HIV) are eligible if they meet all of the following: the is >350 cells/uL at screening, the HIV viral load is below the detectable level, are on a stable ART regimen for at least 4 weeks prior to study entry, and are compliant with their ART

Part 1 and Part 2 (Cohorts A to C and J)

  • Has a confirmed diagnosis of Chronic lymphocytic leukemia/ Small lymphocytic lymphoma (CLL/SLL) with

    • At least 2 (Part 1 only)
    • Part 2 Cohort A: CLL/SLL participants who are to prior therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi), and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received and failed, been intolerant to, or determined by their treating physician to be a poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a PI3Ki per local guidelines
    • Part 2 Cohort B: CLL/SLL participants who are relapsed or refractory following at least 1 line of prior therapy and are BTKi treatment naive
    • Part 2 Cohort C: CLL/SLL participants with 17p deletion or tumor protein p53 (TP53) mutation who are relapsed or refractory following at least 1 line of prior therapy
    • Part 2 Cohort J: CLL/SLL participants whose disease relapsed or was refractory to prior therapy with a covalent/irreversible BTKi and BCL2i. NOTE: As of Protocol Amendment 09, at least 10 CLL/SLL participants whose disease relapsed or was refractory to prior therapy with a covalent/irreversible BTKi, BCL2i and noncovalent/reversible BTKi (all three classes of therapies are required) will be enrolled into Cohort J
    • Has active disease for CLL/SLL clearly documented to initiate therapy
    • For SLL participants in Part 2: Has evaluable core or excisional lymph node for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate at Screening (optional for participants enrolling in Part 1)

Part 2 (Cohorts D to G)

- Has a confirmed diagnosis of and meets the following prior therapy requirements:

  • Participants with Richter's transformation who are relapsed or refractory following at least 1 line of prior therapy (Cohort D)
  • Participants with confirmed Mantle-cell lymphoma (MCL), documented by either overexpression of cyclin D1 or t (11;14), who are relapsed or are refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort E)
  • Participants with Marginal zone lymphoma (MZL) (including splenic, nodal, and extra nodal MZL) who are relapsed or refractory to at least one prior line of systemic therapy including an anti-CD20-based regimen
  • Participants with Follicular lymphoma (FL) who are relapsed or refractory to chemoimmunotherapy and immunomodulatory agents (such as lenalidomide based regimen) (Cohort G)
  • Have defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral Computed tomography (CT) scan
  • Has a lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate (Cohort D) at Screening

Part 2 (Cohort H): confirmed diagnosis of Waldenström's macroglobulinemia (WM); participants who are relapsed or refractory to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi

  • Has active disease defined as 1 of the following: systemic symptoms, physical findings, laboratory abnormalities, coexisting disease
  • Has measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis); IgM ≥450 mg/dL; or bone marrow infiltration of 10%
  • Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at Screening or a lymph node biopsy from an archival

Exclusion criteria

Exclusion Criteria:

  • Has active / infection (Part 1 and Part 2)
  • Has a history of ≤3 years before providing documented . Participants with basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy are not excluded. Participants with low-risk, early-stage prostate cancer (T1-T2a, Gleason score ≤6, and prostate-specific antigen \<10 ng/mL) either treated with definitive intent or untreated in active surveillance with SD are not excluded
  • Has active central nervous system (CNS) disease
  • Has an active infection requiring systemic therapy
  • Has received prior systemic anti-cancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before C1D1
  • Is currently participating in or has participated in a study of an agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
  • Has any gastrointestinal abnormalities that might alter absorption
  • History of severe bleeding disorders
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
490 participants (estimated)

Study arms

  • Experimental
    Nemtabrutinib

    Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.

    Drug: Nemtabrutinib

Interventions

  • Nemtabrutinib tablets administered orally QD.

    Also known as: ARQ 531, MK-1026

06

What researchers measure

Primary outcomes

  1. Part 1: Number of participants experiencing dose-limiting toxicities (DLTs)

    DLTs will be defined as toxicities observed during the first 2 cycles (8 weeks) of Part 1 and include: Grade ≥3 nonhematologic toxicity (except Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension which will not be considered a DLT unless lasting ≥72 hours despite optimal supportive care); Grade 4 hematologic toxicity lasting \>7 days (except Grade 3 lymphocytosis, Grade 4 platelet count decreased of any duration, or Grade 3 platelet count decreased if associated with bleeding); any Grade 3 or Grade 4 nonhematologic laboratory abnormality if values result in drug-induced liver injury, or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for \>1 week (with exceptions); missing \>25% of nemtabrutinib doses as a result of drug-related adverse events (AEs) during the first 2 cycles (8 weeks); Grade 5 toxicity.

    Time frame: Up to ~56 days (Cycles 1-2, cycle = 28 days)

  2. Part 1: Number of participants experiencing adverse events (AEs)

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 1.

    Time frame: Up to ~71 months

  3. Part 1: Number of participants discontinuing study treatment due to AEs

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported for Part 1.

    Time frame: Up to ~42 months

  4. Part 2: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by independent central review (ICR)

    ORR per iwCLL 2018 criteria is defined as the percentage of participants achieving a complete response (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR), or partial response (PR). CR is defined as meeting the following criteria: no lymph nodes \>1.5 cm, spleen size \<13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10\^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10\^9/L or ≥50% increase from screening, hemoglobin \>11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.

    Time frame: Up to ~61 months

  5. Part 2: ORR per Lugano criteria 2014 as assessed by ICR

    ORR per Lugano criteria 2014 is defined as the percentage of participants achieving a CR or PR. CR defined as EITHER CR by imaging (computed tomography \[CT\]): all lymph nodes normal (none ≥15 mm) and normal liver and spleen OR complete metabolic response (CMR): score of 1, 2 or 3 on the 5-point scale assessing fluorodeoxyglucose (FDG) metabolic activity in lymphomatous lesions (ranging from 1=no uptake above background to 5=uptake markedly higher than liver) AND bone marrow (BM) normal by morphology. PR defined as EITHER PR by imaging (CT) with ≥50% decrease in the sum of the product of diameters \[SPD\] of target lesions, no worsening of nontarget lesions, no new lesions and ≥50% spleen abnormal portion OR Partial Metabolic Response (PMR) with score of 4 or 5 on the FDG 5-point scale (with no new lesions) and decreased overall uptake AND residual BM abnormalities; OR CR by imaging with residual BM abnormalities; OR PR by imaging without residual BM abnormalities.

    Time frame: Up to ~61 months

  6. Part 2: ORR per International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria 2014 as assessed by ICR

    ORR per IWWM criteria 2014 is defined as the percentage of participants achieving a CR, very good partial response (VGPR), or PR. CR is defined as all lymph nodes are normal in size (none ≥15 mm), liver and spleen normal in size, serum immunoglobulin M (IgM) values in the normal range, disappearance of monoclonal protein by immunofixation (confirmation needed with a second immunofixation at any subsequent timepoint), and no histological evidence of BM involvement. VGPR is defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in the abnormal portion of the spleen (if previously abnormal), and ≥90% decrease from baseline in serum IgM, or serum IgM values in normal range. PR is defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in serum IgM, and ≥50% decrease from baseline in the abnormal portion of the spleen (if previously abnormal).

    Time frame: Up to ~71 months

Secondary outcomes

  1. Part 1: Area Under the Curve (AUC) of Nemtabrutinib

    Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib AUC (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose \[up to \~57 days\]). Each cycle is 28 days.

    Time frame: At designated time points (up to ~57 days)

  2. Part 1: Minimum Concentration (Cmin) of Nemtabrutinib

    Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib Cmin (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose \[up to \~57 days\]). Each cycle is 28 days.

    Time frame: At designated time points (up to ~57 days)

  3. Part 1: Maximum Concentration (Cmax) of Nemtabrutinib

    Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib Cmax (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose \[up to \~57 days\]). Each cycle is 28 days.

    Time frame: At designated time points (up to ~57 days)

  4. Part 1: ORR per iwCLL criteria 2018 as assessed by ICR

    ORR per iwCLL 2018 criteria is defined as the percentage of participants achieving a CR, CRi, nPR, or PR. CR is defined as meeting the following criteria: no lymph nodes \>1.5 cm, spleen size \<13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10\^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10\^9/L or ≥50% increase from screening, hemoglobin \>11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.

    Time frame: Up to ~71 months

  5. Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR

    For participants with CR, CRi, nPR, or PR per iwCLL 2018 criteria, DOR is defined as the time from the first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR is defined as meeting the following criteria: no lymph nodes \>1.5 cm, spleen size \<13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10\^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10\^9/L or ≥50% increase from screening, hemoglobin \>11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.

    Time frame: Up to ~71 months

  6. Part 2: Number of participants experiencing AEs

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 2.

    Time frame: Up to ~61 months

  7. Part 2: Number of participants discontinuing study treatment due to AEs

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported for Part 2.

    Time frame: Up to ~42 months

  8. Part 2: AUC of Nemtabrutinib

    Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib AUC (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose \[up to \~57 days\]). Each cycle is 28 days.

    Time frame: At designated time points (up to ~57 days)

  9. Part 2: Cmin of Nemtabrutinib

    Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib Cmin (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose \[up to \~57 days\]). Each cycle is 28 days.

    Time frame: At designated time points (up to ~57 days)

  10. Part 2: Cmax of Nemtabrutinib

    Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib Cmax (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose \[up to \~57 days\]). Each cycle is 28 days.

    Time frame: At designated time points (up to ~57 days)

  11. Part 2: DOR per iwCLL criteria 2018 as assessed by ICR

    For participants with CR, CRi, nPR, or PR per iwCLL 2018 criteria, DOR is defined as the time from the first documented evidence of objective response until disease progression or death due to any cause, whichever occurs first. CR is defined as meeting the following criteria: no lymph nodes \>1.5 cm, spleen size \<13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10\^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10\^9/L or ≥50% increase from screening, hemoglobin \>11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.

    Time frame: Up to ~61 months

  12. Part 2: DOR per Lugano criteria 2014 as assessed by ICR

    For participants with CR or PR per Lugano criteria 2014, DOR is defined as the time from the first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR defined as EITHER CR by imaging (CT): all lymph nodes normal (none ≥15 mm) and normal liver and spleen OR CMR: score of 1, 2 or 3 on the 5-point scale assessing FDG metabolic activity in lymphomatous lesions (ranging from 1=no uptake above background to 5=uptake markedly higher than liver and/or new lesions) AND BM normal by morphology. PR defined as EITHER PR by imaging (CT) with ≥50% decrease in the SPD of target lesions, no worsening of nontarget lesions, no new lesions and ≥50% spleen abnormal portion OR PMR with score of 4 or 5 on the FDG 5-point scale (with no new lesions) and decreased overall uptake AND residual BM abnormalities; OR CR by imaging with residual BM abnormalities; OR PR by imaging without residual BM abnormalities.

    Time frame: Up to ~61 months

  13. Part 2: DOR per IWWM criteria 2014 as assessed by ICR

    For participants with CR, VGPR, or PR per IWWM criteria 2014, DOR defined as the time from first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR defined as all lymph nodes normal in size (none ≥15 mm), liver and spleen normal in size, serum IgM values in normal range, disappearance of monoclonal protein by immunofixation (confirmation needed with second immunofixation at any subsequent timepoint), and no histological evidence of BM involvement. VGPR defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in abnormal portion of the spleen (if previously abnormal), and ≥90% decrease from baseline in serum IgM, or serum IgM values in normal range. PR is defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in serum IgM, and ≥50% decrease from baseline in abnormal portion of the spleen (if previously abnormal).

    Time frame: Up to ~61 months

07

Study locations

94 of 121 sites recruiting
  • Highlands Oncology Group ( Site 2728)
    Springdale, Arkansas 72762, United States
    Recruiting
    • Study Coordinator · Contact479-872-8130
  • University of California San Diego Moores Cancer Center ( Site 2717)
    La Jolla, California 92093-0698, United States
    Recruiting
    • Study Coordinator · Contact858-534-5201
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site 2724)
    Torrance, California 90502, United States
    Completed

    Not enrolling at this site — choose another above.

  • Colorado Blood Cancer Institute ( Site 2726)
    Denver, Colorado 80218, United States
    Recruiting
    • Study Coordinator · Contact720-754-4800
  • The University of Louisville, James Graham Brown Cancer Center ( Site 2729)
    Louisville, Kentucky 40202, United States
    Completed

    Not enrolling at this site — choose another above.

  • Mayo Clinic - Rochester ( Site 2706)
    Rochester, Minnesota 55905, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Astera Cancer Care ( Site 2732)
    East Brunswick, New Jersey 08816, United States
    Recruiting
    • Study Coordinator · Contact732-672-6405
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)
    Hackensack, New Jersey 07601, United States
    Recruiting
    • Study Coordinator · Contact551-996-3003
  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)
    Fargo, North Dakota 58102, United States
    Completed

    Not enrolling at this site — choose another above.

  • UT Southwestern-Harold C. Simmons Cancer Center ( Site 2730)
    Dallas, Texas 75390, United States
    Recruiting
    • Study Coordinator · Contact972-695-9450
  • Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)
    Spokane, Washington 99208, United States
    Recruiting
    • Study Coordinator · Contact509-462-2273
  • Hospital Aleman ( Site 0102)
    Ciudad Autonoma de Buenos Aires, Buenos Aires C1118AAT, Argentina
    Recruiting
    • Study Coordinator · Contact+541148277000
  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103)
    Buenos Aires, Buenos Aires F.D. C1431FWO, Argentina
    Recruiting
    • Study Coordinator · Contact+541152990247
  • Fundacion Estudios Clinicos ( Site 0112)
    Rosario, Santa Fe Province S2000DEJ, Argentina
    Recruiting
    • Study Coordinator · Contact+54 0341 238 4171
  • FUNDALEU ( Site 0104)
    Caba, C1114AAN, Argentina
    Recruiting
    • Study Coordinator · Contact5411 48771046
  • Hospital Privado Universitario de Córdoba ( Site 0107)
    Córdoba, X5016KEH, Argentina
    Recruiting
    • Study Coordinator · Contact+541569634187
  • Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110)
    Mendoza, M5500AYB, Argentina
    Completed

    Not enrolling at this site — choose another above.

  • Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)
    Sydney, New South Wales 2747, Australia
    Completed

    Not enrolling at this site — choose another above.

  • Box Hill Hospital ( Site 0203)
    Box Hill, Victoria 3128, Australia
    Recruiting
    • Study Coordinator · Contact+611300342255
  • Sir Charles Gairdner Hospital ( Site 0200)
    Nedlands, Western Australia 6009, Australia
    Recruiting
    • Study Coordinator · Contact+61864573333
  • Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303)
    São Paulo, São Paulo 05403-000, Brazil
    Recruiting
    • Study Coordinator · Contact551145737543
  • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300)
    Rio de Janeiro, 20231-050, Brazil
    Recruiting
    • Study Coordinator · Contact+552132076564
  • BP - A Beneficencia Portuguesa de São Paulo ( Site 0302)
    São Paulo, 01321-001, Brazil
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hospital Paulistano - Amil Clinical Research ( Site 0311)
    São Paulo, 01321-001, Brazil
    Recruiting
    • Study Coordinator · Contact+551130161340
  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0401)
    Calgary, Alberta T2N 5G2, Canada
    Recruiting
    • Study Coordinator · Contact4035213723
  • The Ottawa Hospital ( Site 0404)
    Ottawa, Ontario K1H 8L6, Canada
    Recruiting
    • Study Coordinator · Contact613 737-7700
  • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406)
    Toronto, Ontario M5G 2M9, Canada
    Recruiting
    • Study Coordinator · Contact416-946-2827
  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403)
    Montreal, Quebec H1T 2M4, Canada
    Recruiting
    • Study Coordinator · Contact5142523400
  • Jewish General Hospital ( Site 0400)
    Montreal, Quebec H3T 1E2, Canada
    Recruiting
    • Study Coordinator · Contact5143408222 x 24572
  • Anhui Provincial Hospital ( Site 2808)
    Hefei, Anhui 230071, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Peking University Third Hospital-Hematology ( Site 2827)
    Beijing, Beijing Municipality 100191, China
    Recruiting
    • Study Coordinator · Contact010-82266699
  • The Second Affiliated Hospital of Chongqing Medical University ( Site 2825)
    Chongqing, Chongqing Municipality 400072, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824)
    Guangzhou, Guangdong 510060, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Liuzhou People's Hospital ( Site 2817)
    Liuzhou, Guangxi 545006, China
    Recruiting
    • Study Coordinator · Contact+8607722662950
  • Guangxi Medical University Cancer Hospital ( Site 2814)
    Nanning, Guangxi 530028, China
    Recruiting
    • Study Coordinator · Contact+8607715323174
  • Henan Cancer Hospital-hematology department ( Site 2802)
    Zhengzhou, Henan 450008, China
    Recruiting
    • Study Coordinator · Contact0371-65588007
  • Wuhan Union Hospital ( Site 2816)
    Wuhan, Hubei 430022, China
    Recruiting
    • Study Coordinator · Contact+8618627091655
  • The Second Xiangya Hospital of Central South University ( Site 2820)
    Changsha, Hunan 410011, China
    Recruiting
    • Study Coordinator · Contact+8613975806137
  • Hunan Cancer Hospital ( Site 2822)
    Changsha, Hunan 410013, China
    Recruiting
    • Study Coordinator · Contact0731-88651669
  • Jiangsu Province Hospital ( Site 2823)
    Nanjing, Jiangsu 210029, China
    Recruiting
    • Study Coordinator · Contact025-86211033
  • The Affiliated Hospital of Xuzhou Medical College ( Site 2818)
    Xuzhou, Jiangsu 221000, China
    Completed

    Not enrolling at this site — choose another above.

  • The First Affiliated Hospital of Nanchang University ( Site 2815)
    Nanchang, Jiangxi 330006, China
    Recruiting
    • Study Coordinator · Contact13970038386
  • The First Hospital of Jilin University-Hematology ( Site 2803)
    Changchun, Jilin 130021, China
    Recruiting
    • Study Coordinator · Contact0431-88786014
  • Fudan University Shanghai Cancer Center ( Site 2801)
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
    • Study Coordinator · Contact+8602164175590
  • Huashan Hospital, Fudan University ( Site 2821)
    Shanghai, Shanghai Municipality 200040, China
    Recruiting
    • Study Coordinator · Contact021-52889999
  • West China Hospital Sichuan University ( Site 2810)
    Chengdu, Sichuan 610041, China
    Recruiting
    • Study Coordinator · Contact+86028-85422114
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Unio ( Site 2800)
    Tianjin, Tianjin Municipality 301617, China
    Recruiting
    • Study Coordinator · Contact+8615900265415
  • The First Affiliated Hospital, Zhejiang University ( Site 2826)
    Hangzhou, Zhejiang 310002, China
    Recruiting
    • Study Coordinator · Contact057187236114
  • Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0600)
    Brno, Brno-mesto 625 00, Czechia
    Recruiting
    • Study Coordinator · Contact+420532233642
  • Fakultni nemocnice Hradec Kralove ( Site 0601)
    Hradec Králové, 500 05, Czechia
    Recruiting
    • Study Coordinator · Contact+420495832159
  • Aarhus University Hospital ( Site 0702)
    Aarhus N, Central Jutland 8200, Denmark
    Completed

    Not enrolling at this site — choose another above.

  • Aalborg Universitetshospital ( Site 0703)
    Aalborg, North Denmark 9000, Denmark
    Recruiting
    • Study Coordinator · Contact+45 97660000
  • Sjællands Universitetshospital Køge ( Site 0701)
    Koege, Region Sjælland 4600, Denmark
    Recruiting
    • Study Coordinator · Contact+45 46323200
  • Odense University Hospital ( Site 0705)
    Odense C, Region Syddanmark 5000, Denmark
    Completed

    Not enrolling at this site — choose another above.

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810)
    Nice, Alpes-Maritimes 06202, France
    Recruiting
    • Study Coordinator · Contact+33 4 92 03 57 85
  • Centre Hospitalier Lyon-Sud ( Site 0804)
    Pierre-Bénite, Auvergne-Rhône-Alpes 69495, France
    Recruiting
    • Study Coordinator · Contact+33478864348
  • Institut Paoli-Calmettes ( Site 0803)
    Marseille, Bouches-du-Rhone 13009, France
    Recruiting
    • Study Coordinator · Contact+33491223537
  • Centre Hospitalier de Versailles ( Site 0809)
    Le Chesnay, Yvelines 78150, France
    Completed

    Not enrolling at this site — choose another above.

  • Hopital Saint Louis ( Site 0805)
    Paris, 75010, France
    Recruiting
    • Study Coordinator · Contact+33142499236
  • Universitaetsklinikum Ulm. ( Site 0906)
    Ulm, Baden-Wurttemberg 89081, Germany
    Recruiting
    • Study Coordinator · Contact+ 49 731 500 45901
  • Universitaetsklinikum Koeln ( Site 0901)
    Cologne, North Rhine-Westphalia 50937, Germany
    Recruiting
    • Study Coordinator · Contact+4922147897046
  • St. Marien-Krankenhaus Siegen ( Site 0914)
    Siegen, North Rhine-Westphalia 57072, Germany
    Completed

    Not enrolling at this site — choose another above.

  • Universitaetsklinikum Carl Gustav Carus ( Site 0902)
    Dresden, Saxony 01307, Germany
    Recruiting
    • Study Coordinator · Contact0049 351 458 5692
  • Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202)
    Pécs, Baranya 7624, Hungary
    Recruiting
    • Study Coordinator · Contact+3672536000
  • Debreceni Egyetem Klinikai Kozpont ( Site 1201)
    Debrecen, Hajdú-Bihar 4032, Hungary
    Recruiting
    • Study Coordinator · Contact+3652255196
  • Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1206)
    Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary
    Recruiting
    • Study Coordinator · Contact+3642599700
  • Orszagos Onkologiai Intezet ( Site 1200)
    Budapest, 1122, Hungary
    Recruiting
    • Study Coordinator · Contact+3612248600
  • Beaumont Hospital ( Site 2900)
    Dublin, Dublin 9, Ireland
    Recruiting
    • Study Coordinator · Contact+35318092010
  • University Hospital Limerick ( Site 2903)
    Limerick, V94 F858, Ireland
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Ha Emek Medical Center ( Site 1305)
    Afula, 1834111, Israel
    Recruiting
    • Study Coordinator · Contact972-46494052
  • Soroka Medical Center ( Site 1307)
    Beersheba, 8410101, Israel
    Recruiting
    • Study Coordinator · Contact+97286403827
  • Rambam Medical Center ( Site 1301)
    Haifa, 3109601, Israel
    Recruiting
    • Study Coordinator · Contact+97247772547
  • Hadassah Ein Karem Jerusalem ( Site 1300)
    Jerusalem, 9112001, Israel
    Recruiting
    • Study Coordinator · Contact+97226778180
  • Chaim Sheba Medical Center ( Site 1302)
    Ramat Gan, 5262001, Israel
    Recruiting
    • Study Coordinator · Contact+97235308401
  • Kaplan Medical Center ( Site 1304)
    Rehovot, 76100, Israel
    Recruiting
    • Study Coordinator · Contact+97289441726
  • Sourasky Medical Center ( Site 1303)
    Tel Aviv, 6423906, Israel
    Recruiting
    • Study Coordinator · Contact+97236973782
  • Istituto Tumori Giovanni Paolo II ( Site 1409)
    Bari, 70124, Italy
    Completed

    Not enrolling at this site — choose another above.

  • A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400)
    Bologna, 40138, Italy
    Recruiting
    • Study Coordinator · Contact+390516363680
  • ASST Spedali Civili di Brescia ( Site 1408)
    Brescia, 25123, Italy
    Recruiting
    • Study Coordinator · Contact+39 0303996416
  • IRCCS Ospedale San Raffaele ( Site 1402)
    Milan, 20132, Italy
    Recruiting
    • Study Coordinator · Contact00390226434797
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)
    Naples, 80131, Italy
    Recruiting
    • Study Coordinator · Contact+39 0815903 382
  • Fondazione IRCCS Policlinico San Matteo ( Site 1407)
    Pavia, 27100, Italy
    Recruiting
    • Study Coordinator · Contact+39 0382503084
  • IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)
    Reggio Emilia, 42123, Italy
    Recruiting
    • Study Coordinator · Contact+39 0522295654
  • Policlinico Umberto I ( Site 1404)
    Roma, 00161, Italy
    Completed

    Not enrolling at this site — choose another above.

  • Pratia MCM Krakow ( Site 1601)
    Krakow, Lesser Poland Voivodeship 30-727, Poland
    Recruiting
    • Study Coordinator · Contact48 12 2954135
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1606)
    Wroclaw, Lower Silesian Voivodeship 50-367, Poland
    Completed

    Not enrolling at this site — choose another above.

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1608)
    Warsaw, Masovian Voivodeship 02-781, Poland
    Recruiting
    • Study Coordinator · Contact+48225462223
  • Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)
    Opole, Opole Voivodeship 45-061, Poland
    Completed

    Not enrolling at this site — choose another above.

  • Szpitale Pomorskie Sp. z o.o. ( Site 1600)
    Gdynia, Pomeranian Voivodeship 81-519, Poland
    Completed

    Not enrolling at this site — choose another above.

  • Spitalul Clinic Colțea ( Site 1805)
    Bucharest, Bucharest 030171, Romania
    Recruiting
    • Study Coordinator · Contact0040213874100
  • Ovidius Clinical Hospital ( Site 1804)
    Ovidiu, Constanța County 905900, Romania
    Completed

    Not enrolling at this site — choose another above.

  • Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 1802)
    Brasov, 500052, Romania
    Recruiting
    • Study Coordinator · Contact0729075567
  • Institutul Regional de Oncologie Iasi ( Site 1801)
    Iași, 700483, Romania
    Recruiting
    • Study Coordinator · Contact40374278811
  • Severance Hospital Yonsei University Health System ( Site 2201)
    Seoul, 03722, South Korea
    Recruiting
    • Study Coordinator · Contact+82222281972
  • Samsung Medical Center ( Site 2200)
    Seoul, 06351, South Korea
    Recruiting
    • Study Coordinator · Contact+82234106548
  • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000)
    L'Hospitalet de Llobregat, Barcelona 08908, Spain
    Recruiting
    • Study Coordinator · Contact+34932607750
  • Hospital Universitario de Salamanca ( Site 2002)
    Salamanca, Castille and León 37007, Spain
    Recruiting
    • Study Coordinator · Contact34923 29 11 00x55974
  • CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2005)
    A Coruña, La Coruna 15006, Spain
    Recruiting
    • Study Coordinator · Contact34981178000
  • Hospital General Universitario de Alicante ( Site 2007)
    Alicante, 03010, Spain
    Recruiting
    • Study Coordinator · Contact965 93 30 00
  • Hospital Universitari Vall d'Hebron ( Site 2001)
    Barcelona, 08035, Spain
    Recruiting
    • Study Coordinator · Contact+34934893806

Showing the first 100 of 121 sites across 22 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · externaldatasharing-msd.com

09

Updates

3 registry updates since Sep 25, 2026
Sites
1 site added, 1 site removed. 3 sites changed recruiting status (2 now completed, 1 now active, not recruiting)
Show 3 sites
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1606) · Wroclaw, PolandActive, not recruiting→Completed
  • University Hospital Limerick ( Site 2903) · Limerick, IrelandRecruiting→Active, not recruiting
  • Istituto Tumori Giovanni Paolo II ( Site 1409) · Bari, ItalyActive, not recruiting→Completed
Show site
  • Sjællands Universitetshospital Køge ( Site 0701) · Koege, Denmark
Show 1 removed
  • Sjaellands Universitetshospital Roskilde ( Site 0701) · Roskilde, Denmark
across 3 updates, Oct 5, 2026 – Oct 27, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • University Hospital Limerick ( Site 2903) · Limerick, IrelandContact removed •••8320
Oct 15, 2026
Show all 3 updates
  1. Oct 27, 2026
    1 site added, 1 site removed. Istituto Tumori Giovanni Paolo II ( Site 1409) is now Completed
    Show site
    • Sjællands Universitetshospital Køge ( Site 0701) · Koege, Denmark
    Show 1 removed
    • Sjaellands Universitetshospital Roskilde ( Site 0701) · Roskilde, Denmark
  2. Oct 15, 2026
    University Hospital Limerick ( Site 2903) is now Active, not recruiting
    Site contacts Changed at 1 site. See the sites
    Show the site
    • University Hospital Limerick ( Site 2903) · Limerick, IrelandContact removed •••8320
  3. Oct 5, 2026
    Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1606) is now Completed
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04728893
Responsible party
Sponsor
First posted
Jan 28, 2021
Start date
Apr 5, 2021
Primary completion
Jan 4, 2029 (estimated)
Completion
Jan 4, 2029 (estimated)
Last update
Oct 27, 2026

Study contacts

Toll Free Number
Contact
Trialsites@msd.com
1-888-577-8839
Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: ARQ531

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