ClinicalTrials.gg
RecruitingNCT05910801V-MINDUpdated Nov 18, 2024

Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

A Phase 2 interventional study of Biopsy and Biospecimen Collection in Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, sponsored by Academic and Community Cancer Research United. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.

Sponsored by Academic and Community Cancer Research United · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial tests how well tafasitamab, lenalidomide and venetoclax work in treating patients with mantle cell lymphoma that has come back (after a period of improvement) (relapsed) or that has not responded to previous treatment (refractory). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving tafasitamab, lenalidomide and venetoclax together may kill cancer cells more efficiently in patients with relapsed or refractory mantle cell lymphoma.

Read the detailed description

PRIMARY OBJECTIVE:

I. To evaluate the overall response rate in patients with relapsed/refractory mantle cell lymphoma after treatment with tafasitamab, lenalidomide and venetoclax combination.

SECONDARY OBJECTIVES:

I. To estimate the complete response rate in patients with relapsed/refractory mantle cell lymphoma after treatment with tafasitamab, lenalidomide and venetoclax combination.

II. To estimate the duration of response (DoR) in patients with relapsed/refractory mantle cell lymphoma after treatment with tafasitamab, lenalidomide and venetoclax combination.

III. To estimate the progression free survival (PFS) in patients with relapsed/refractory mantle cell lymphoma after treatment with tafasitamab, lenalidomide and venetoclax combination.

IV. To estimate the overall survival (OS) in patients with relapsed/refractory mantle cell lymphoma after treatment with tafasitamab, lenalidomide and venetoclax combination.

V. To evaluate the safety profile of tafasitamab, lenalidomide and venetoclax combination in patients with relapsed/refractory mantle cell lymphoma.

CORRELATIVE OBJECTIVES:

I. To assess the rate of undetectable minimal residual disease (uMRD) in peripheral blood by multi-color flow cytometry.

II. To assess the correlation between MRD status with clinical outcomes such as DoR, PFS and OS.

OUTLINE: Patients receive tafasitamab intravenously (IV), lenalidomide orally (PO) and venetoclax PO while on study. Patients may undergo lumbar puncture during screening. Patients undergo computed tomography (CT) scan and blood sample collection and may undergo magnetic resonance imaging (MRI) and tumor biopsy on study and during follow-up. Patients undergo positron emission tomography (PET)/CT, bone marrow biopsy, and bone marrow aspirate throughout the study.

After treatment completion, patients follow up every 3 months for 1 year, every 4 months for 1 year and then every 6 months until up to 5 years after entering the trial.

02

Conditions studied

  • Recurrent Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma
03

In context

Lymphoma, Mantle-Cell

1,220 studies on the registry are indexed under Lymphoma, Mantle-Cell; 154 are open to participants now.

This study's planned enrollment of 100 is above the median of 37 across 1,001 interventional studies indexed under Lymphoma, Mantle-Cell.

Browse Lymphoma, Mantle-Cell studies →

Lead sponsor

Academic and Community Cancer Research United is the lead sponsor of 50 studies on the registry; 4 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) 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

  • Age >= 18 years old
  • Confirmed pathology diagnosis of mantle cell lymphoma (MCL) with t(11;14)(q13;q32) translocation or cyclin D1 overexpression NOTE: Patients with MCL after prior anti-CD19 therapy (such as chimeric antigen receptor [CAR] T-cell therapy) should have confirmed preserved expression of CD19, unless a is not feasible or associated with a high risk of complications in the treating physician's opinion
  • Relapsed or refractory disease, which is defined as patients with >= 1 line of prior systemic treatment NOTE: Prior exposure to lenalidomide or venetoclax is allowed, provided there was no disease progression on lenalidomide or venetoclax
  • In the view of the treating physician, the patient is in need of treatment, for example, with lymphoma-related symptoms or cytopenia
  • Evaluable disease, which is defined as at least one lymph node or other type of lesion that has a size >= 1.5 cm, or spleen size >= 15 cm or white blood cell (WBC) >= 30,000/mm\^3 in leukemic non-nodal MCL patients
  • Performance Status (PS) 0, 1, or 2
  • (ANC) >= 1500/mm\^3 (obtained =\< 14 days prior to registration)
  • count >= 75,000/mm\^3 (>= 50,000/mm\^3 if there is evidence of bone marrow involvement by MCL or hypersplenism) (obtained =\< 14 days prior to registration)
  • > 8.0 g/dL (obtained =\< 14 days prior to registration)
  • (aPTT) or partial thromboplastin time (PTT) =\< 1.5 × upper normal limit () (obtained =\< 14 days prior to registration)
  • Prothrombin (PT) or international normalized ratio (INR) =\< 1.5 × upper normal limit (ULN) (obtained =\< 14 days prior to registration)
  • Total =\< 1.5 × ULN (or =\< 3 × ULN if there is evidence of parenchymal liver involvement with MCL or documented Gilbert's disease) (obtained =\< 14 days prior to registration)
  • (ALT) and aspartate transaminase (AST) =\< 3 × ULN (or =\< 5 × ULN if there is evidence of parenchymal liver involvement with MCL) (obtained =\< 14 days prior to registration)
  • Calculated > 60 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration)
  • Negative pregnancy test done =\< 7 days prior to registration, for women of only NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required NOTE: Females of reproductive potential include all females who are menstruating, amenorrheic from previous medical treatments, under 50 years of age, and/or perimenopausal, and do not qualify for the females not of reproductive potential category. Females not of reproductive potential include females who have been in natural menopause for at least 24 consecutive months, or who have had a hysterectomy and/or bilateral oophorectomy, or female children who have not started menstruating
  • Agree to use effective during study treatment and for 4 weeks after last dose of lenalidomide and for 3 months after last dose of tafasitamab (whichever is longer) Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control simultaneously: one highly effective form of contraception - tubal ligation, intrauterine device (IUD), hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner's vasectomy, and one additional effective contraceptive method - male latex or synthetic condom, diaphragm, or cervical cap. Contraception should continue during therapy, during dose interruptions, and for 4 weeks following discontinuation of lenalidomide and for 3 months after discontinuation of tafasitamab (whichever is longer). Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. If needed, females of reproductive potential should be referred to a qualified provider of contraceptive methods Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential during trial therapy, during dose interruptions, and for 4 weeks following discontinuation of lenalidomide and for 3 months after discontinuation of tafasitamab (whichever is longer), even if they have undergone a successful vasectomy. Male patients must not donate sperm
  • Willing to be registered into the mandatory REVLIMID REMS (trademark) program, and willing and able to comply with the requirements of the REVLIMID REMS program
  • Able to take low-dose aspirin (81 mg) daily or an alternative form of anticoagulation
  • Subject must voluntarily sign and date an =\< 28 days prior to registration
  • Willing to return to enrolling institution for follow-up during the active monitoring phase (i.e., active treatment and clinical follow-up) of the study
  • Willing to provide mandatory blood specimens for correlative research and banking for future correlative research pertinent to this study

Exclusion criteria

Exclusion Criteria:

  • Any of the following:

    • Pregnant persons
    • Nursing persons (lactating persons are eligible provided that they agree not to use their breast milk to feed while receiving treatment on the study or within 3 months of the last dose of study treatment)
    • Men or women of who are unwilling to employ adequate during treatment and for 4 weeks after last dose of lenalidomide or for 3 months after last dose of tafasitamab (whichever is longer)
  • Any of the following prior therapies:

    • stem cell transplant =\< 90 days prior to registration
    • Allogeneic stem cell transplant
    • Anti-CD19 CAR T-cell therapy =\< 90 days prior to registration
  • Any central nervous system (CNS) involvement by MCL (e.g., any parenchymal, , cerebrospinal fluid [CSF], cranial or spinal nerve root involvement)
  • Receiving any other treatment which would be considered as a treatment for MCL (with the exception of ). If a patient received recent MCL treatment prior to registration, at least 5 half-lives of the drug(s) OR 14 days must have passed following the last dose for the patient to be eligible
  • Any of the following medication requirement or recent use:

    • Anticoagulation with a vitamin K antagonist =\< 7 days prior to registration
    • Requirement of a P-gp inhibitor during the study
    • Requirement of a strong cytochrome P450 (CYP) 3A inhibitor or inducer during the study
    • Use of a strong or moderate inhibitor or inducer =\< 7 days prior to registration

NOTE: Because of their effect on CYP3A4, use of any of the following within 3 days of registration or planned use during study participation is prohibited:

  • Grapefruit or grapefruit products
  • Seville oranges or products from Seville oranges
  • Star fruit

    • (HIV) positive. All subjects will be screened for HIV =\< 14 days prior to registration
    • Patient with chronic virus (HBV) or (HCV) requiring treatment. All subjects will be screened for hepatitis B and hepatitis C =\< 14 days prior to registration NOTE: Patients with positive hepatitis B surface antigen (HBsAg) are excluded from participation in this trial. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation. Patients who are hepatitis B PCR positive will be excluded from participating in this trial NOTE: Patients with positive hepatitis C antibody need to have a negative result for hepatitis C ribonucleic acid (RNA). Patients who are hepatitis C RNA positive will be excluded from participating in this trial
    • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the local investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
    • Uncontrolled intercurrent illness, in the judgement of the local investigator, including, but not limited to:
  • (NYHA) class III or IV or symptomatic congestive heart failure
  • Unstable angina or acute coronary syndrome =\< 3 months prior to registration
  • Uncontrolled or symptomatic cardiac arrhythmia

    • NOTE: Patients with pacemakers are eligible if they have no history of fainting or arrhythmias while using the pacemaker
  • Oxygen dependent baseline lung disease (such as interstitial lung disease or [COPD])
  • Ongoing inflammatory bowel disease (such as ulcerative colitis) requiring active treatment
  • Ongoing malabsorption syndrome or other condition that precludes enteral route of administration
  • Ongoing or active infection (viral, bacterial, or fungal)
  • Psychiatric illness/social situations that would limit compliance with study requirements

    • History of the following:
  • Cerebral vascular accident within 24 weeks prior to registration
  • Myocardial infarction within 24 weeks prior to registration
  • Major surgery =\< 28 days prior to registration
  • =\< 28 days prior to registration
  • Life-threatening thrombosis/embolism
  • Bleeding diathesis that precludes the use of low-dose aspirin (81 mg daily) or any form of anticoagulation

    • Other active primary (other than localized non-melanotic skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to =\< 2 years NOTE: If there is a history of prior malignancy, the patient must be in remission not require ongoing therapy such as radiation, chemotherapy or immunotherapy for their cancer. Patients on hormonal therapy for adequately treated nonmetastatic breast or prostate cancer are permitted if they meet other eligibility criteria
    • Unable to swallow oral drugs
Terms in these criteria, in plain language(27)

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.

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.

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.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

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.

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.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

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.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

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

Study arms

  • Experimental
    Treatment (Tafasitamab, lenalidomide, venetoclax)

    Patients receive tafasitamab IV, lenalidomide PO and venetoclax PO while on study. Patients may undergo lumbar puncture during screening. Patients undergo CT scan and blood sample collection and may undergo MRI and tumor biopsy on study and during follow-up. Patients undergo PET/CT, bone marrow biopsy, and bone marrow aspirate throughout the study.

    Procedure: Biopsy · Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration · Procedure: Bone Marrow Biopsy · Procedure: Computed Tomography · Drug: Lenalidomide · Procedure: Lumbar Puncture · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Biological: Tafasitamab · Drug: Venetoclax

Interventions

  • ProcedureBiopsy

    Undergo biopsy

    Also known as: BIOPSY_TYPE, Bx

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

  • ProcedureBone Marrow Aspiration

    Undergo bone marrow aspiration

  • ProcedureBone Marrow Biopsy

    Undergo bone marrow biopsy

    Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

  • ProcedureComputed Tomography

    Undergo CT scan

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

  • Given PO

    Also known as: CC-5013, CC5013, CDC 501, Revlimid

  • ProcedureLumbar Puncture

    Undergo lumbar puncture

    Also known as: LP, Spinal Tap

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

  • ProcedurePositron Emission Tomography

    Undergo PET/CT scan

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

  • BiologicalTafasitamab

    Given IV

    Also known as: Immunoglobulin, Anti-(Human Cd19 Antigen) (Human-mus musculus Monoclonal MOR00208 Heavy Chain), Disulfide with Human-mus musculus Monoclonal MOR00208 .Kappa.-chain, Dimer, Monjuvi, MOR-00208, MOR00208, MOR208, Tafasitamab-cxix, XmAb5574

  • Given PO

    Also known as: ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto

06

What researchers measure

Primary outcomes

  1. Objective response rate

    A response is defined to be either a partial metabolic response (PMR) or complete metabolic response (CMR) by positron emission tomography (PET) or a partial response (PR) or complete response (CR) by computed tomography (CT) noted as the objective status using Lugano criteria. Objective response rate is defined as the proportion of evaluable patients who achieve response while on treatment. Estimate and corresponding 95% confidence intervals will be calculated according to the approach of Duffy and Santner.

    Time frame: Up to 5 years

Secondary outcomes

  1. Complete response rate

    Will be estimated for each cohort by the total number of patients who achieve a CMR (by PET/CT) or CR (by CT) at any time on treatment divided by the total number of evaluable patients. Point estimate for complete response rate and corresponding 95% confidence interval will be provided using exact method.

    Time frame: Up to 5 years

  2. Duration of response

    Will be estimated using the method of Kaplan-Meier separately for each cohort.

    Time frame: From first documentation of objective status(PMR or CMR by PET/CT, or PR or CR by CT) to the earliest date of progression or death, assessed up to 5 years

  3. Progression free survival

    Will be estimated using method of Kaplan-Meier separately for each cohort.

    Time frame: From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years

  4. Overall survival

    Will be estimated using method of Kaplan-Meier for each cohort.

    Time frame: From registration to death due to any cause, assessed up to 5 years

  5. Incidence of adverse events (AE)

    The maximum grade for each type of AE from each patient will be used for analysis, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the AE(s) to the study treatment will be taken into consideration. Adverse events will be reported separately for each cohort.

    Time frame: Up to 5 years

07

Study locations

1 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Dec 2029, 71 months after the start.

Of 153 non-industry phase 2 interventional studies under Lymphoma, Mantle-Cell, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's planned 71 months is above that.

Counting every sponsor, half of 183 studies reached it within 63 months; a quarter within 38 and three quarters within 106.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 9, 2023
First posted
Jun 20, 2023
StartActual
Jan 4, 2024
Primary completionEst.
Dec 30, 2029
CompletionEst.
Dec 30, 2030
Last update
Nov 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05910801
Lead sponsor
Academic and Community Cancer Research United
Responsible party
Sponsor
First posted
Jun 20, 2023
Start date
Jan 4, 2024
Primary completion
Dec 30, 2029 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Nov 18, 2024

Study contacts

Inbox Mayo Clinic Cancer Studies
Contact
MAYOCLINICCANCERSTUDIES@mayo.edu
507-538-5424
Yucai Wang
principal investigator · Academic and Community Cancer Research United

Oversight

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

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Studies of the drugs tested here: Lenalidomide · Tafasitamab · Venetoclax

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