ClinicalTrials.gg
CompletedNCT03479268Updated Nov 10, 2026

Pevonedistat and Ibrutinib in Treating Participants With Relapsed or Refractory CLL or Non-Hodgkin Lymphoma

A Phase 1 interventional study of Ibrutinib and Laboratory Biomarker Analysis in B-Cell Prolymphocytic Leukemia, Recurrent Chronic Lymphocytic Leukemia and Recurrent Diffuse Large B-Cell Lymphoma, sponsored by City of Hope Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by City of Hope Medical Center · Phase 1, Interventional, and Treatment

Updated Nov 10, 2026Now CompletedPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 83 studies testing ibrutinib in Leukemia, Lymphocytic, Chronic, B-Cell — 8 open to participants now, 28 under way, 4 of them phase 3. ibrutinib · Leukemia, Lymphocytic, Chronic, B-Cell.

Enrollment
66th of 83
18 · median 44
Started
2018
with 7 others
Phase 1
17 of 83
1 open now
Registered
59th of 83
by date
Lead sponsor
2 of 83
City of Hope Medical Center

Among the 83 studies testing ibrutinib in Leukemia, Lymphocytic, Chronic, B-Cell, this one is the 66th largest by enrollment, is one of 8 that started in 2018, is one of 17 in phase 1, and was the 59th registered.

By phase

83 studies; the count open now beside each. This study's row is marked.

Phase 243 · 6 open
Phase 1this study17 · 1 open
Phase 314 · 0 open
Phase 1/27 · 1 open
Phase 2/31 · 0 open
Phase 41 · 0 open

By the year they started

First in 2010; this study’s year is marked. 8 started in 2018.

Size and results

Median enrollment 44 across the 83 interventional studies. Of the 44 that completed or were terminated, 26 (59%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 83 studies testing ibrutinib in Leukemia, Lymphocytic, Chronic, B-Cell, or all of them as a file.
02

Study summary

This phase I trial studies the side effects and best dose of pevonedistat when given together with ibrutinib in participants with chronic lymphocytic leukemia or non-Hodgkin lymphoma that has come back or has stopped responding to other treatments. Pevonedistat and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of pevonedistat administered in combination with ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL).

SECONDARY OBJECTIVES:

I. Overall response rate (ORR) will be determined based on the proportion of study participants who achieve complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR) or nodular partial response (nPR) assessed after completion of therapy.

II. Event-free survival (EFS), defined as the interval between the date of first study treatment and the date of objective signs of disease recurrence, subsequent anti-leukemic therapy, or death, whichever is first reported.

OUTLINE: This is a dose-escalation study of pevonedistat.

Participants receive pevonedistat intravenously (IV) over 1 hour on days 1, 3, and 5, and ibrutinib orally (PO) daily on days 2-21 of course 1 and days 1-21 of subsequent courses. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Participants then receive only ibrutinib PO daily on days 1-21. Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants will be followed up for every 3 months

03

Conditions studied

  • B-Cell Prolymphocytic Leukemia
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Lymphoplasmacytic Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Follicular Lymphoma
  • Refractory Lymphoplasmacytic Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Refractory Marginal Zone Lymphoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Small Lymphocytic Lymphoma
  • Richter Syndrome
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

  • Dose escalation cohort:

    • Histologically or flow cytometry confirmed diagnosis of B-CLL/small lymphocytic lymphoma (SLL) according to National Cancer Institute sponsored Working Group (NCI-WG) 1996 guidelines
    • The following types of NHL as documented by medical records and with histology based on criteria established by the World Health Organization (WHO):

      • Mantle cell lymphoma (MCL)
      • Follicular lymphoma (FL) - grades 1-3a
      • Lymphoplasmacytic lymphoma (LPL)
      • Marginal zone lymphoma (MZL)
      • CLL in Richter's transformation
      • B-cell prolymphocytic leukemia (B-PLL)
      • Diffuse large B-cell lymphoma (DLBCL)
  • Expansion cohort - histologically or flow cytometry confirmed diagnosis of B-CLL/SLL according to NCI-WG 1996 guidelines; patients who lack CD23 expression on their leukemia cells should be examined for (and found NOT to have) either t(11;14) or cyclin D1 overexpression, to rule out mantle cell lymphoma
  • Patients with MCL underwent >= 1 chemoimmunotherapy-based regimen; patients with FL and MZL underwent >= 1 prior chemotherapy-based and/or immunotherapy-based regimen; patients with DLBCL and CLL in Richter's transformation underwent >= 1 chemoimmunotherapy-based regimen and are not transplant-eligible; patients with CLL, B-PLL and LPL underwent >= 1 chemotherapy-based, or immunotherapy-based or targeted therapy regimen (e.g., PI3K inhibitors [idelalisib], venetoclax, ibrutinib or an agent, including an investigational BTK inhibitor); all regimens must have been administered for >= 2 cycles, and patients must have had either documented disease progression or no response (stable disease) to the most recent treatment regimen
  • Patients with CLL/SLL demonstrate active disease meeting at least 1 of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for requiring treatment:

    • A minimum of any one of the following constitutional symptoms:

      • Unintentional weight loss > 10% within the previous 6 months prior to screening
      • Extreme fatigue (unable to work or perform usual activities)
      • Fevers of greater than 100.5 F for >= 2 weeks without evidence of infection
      • Night sweats without evidence of infection
    • Evidence of progressive marrow failure as manifested by the development of, or worsening of anemia or thrombocytopenia
    • Massive (i.e., > 6 cm below the left costal margin), progressive or symptomatic splenomegaly
    • Massive nodes or clusters (i.e., > 10 cm in longest diameter) or progressive lymphadenopathy
    • Progressive lymphocytosis with an increase of > 50% over a 2-month period, or an anticipated doubling time of less than 6 months
    • anemia or thrombocytopenia that is poorly responsive to
    • Patients with NHL and with B-cell prolymphocytic leukemia must have an indication for treatment in the opinion of the investigator
  • For diseases other than LPL and CLL, presence of radiographically measurable lymphadenopathy or extra-nodal lymphoid (defined as the presence of >= 1 lesion that measures >= 2.0 cm in the longest dimension [LD] and >= 1.0 cm in the longest perpendicular dimension [LPD] as assessed by computed tomography [CT] or magnetic resonance imaging [MRI]); for LPL, will be defined as serum monoclonal IgM > 0.5 g/dL or meeting at least 1 of the recommendations from the Second International Workshop on LPL for requiring treatment
  • Patients must have (ECOG) performance status 0-2 and expected survival > 3 months from study enrollment
  • Total =\< institutional (ULN) (unless due to known Gilbert's syndrome or compensated hemolysis directly attributable to CLL); patients with Gilbert's syndrome may enroll if direct bilirubin =\< 1.5 x ULN of the direct bilirubin; elevated indirect bilirubin due to post-transfusion hemolysis is allowed
  • (AST) or alanine aminotransferase (ALT) less than 2.5 X institutional ULN
  • Estimated (CrCL) using the Cockcroft-Gault equation >= 50 mL/min
  • >= 50,000/mm\^3 independent of transfusion support, with no active bleeding, and >= 1000/mm\^3, unless due to disease involvement in the bone marrow
  • Albumin > 2.7 g/dL
  • > 8 g/dL; patients may be transfused to achieve this value
  • Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
  • Female patients who:

    • Are for at least 1 year before the screening visit, OR
    • Are surgically sterile, OR
    • If they are of :
    • Agree to practice 1 highly effective method and 1 additional effective (barrier) method of at the same time, from the time of signing the through 4 months after the last dose of study drug, OR
    • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)
  • Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:

    • Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR
    • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)

Exclusion criteria

Exclusion Criteria:

  • Prior therapeutic intervention with any of the following:

    • Therapeutic anticancer antibodies (rituximab, obinutuzumab) within 4 weeks
    • Radio- or toxin-immunoconjugates within 10 weeks
    • Inhibitors of PI3K (idelalisib), ibrutinib, BH3-mimetic venetoclax, lenalidomide, and other targeted therapy (including BTK inhibitors and other investigational therapy) within 6 half-lives
    • All other chemotherapy, radiation therapy within 3 weeks prior to initiation of therapy
  • Intolerance of ibrutinib
  • Inadequate recovery from adverse events related to prior therapy to grade =\< 1 (excluding grade 2 alopecia and neuropathy)
  • Chronic use of in excess of prednisone 20 mg/day or its equivalent
  • Stem cell transplant recipients must have no evidence of active and should not be receiving treatment for it
  • Known involvement of central nervous system
  • Use of full dose, therapeutic anti-coagulation or patients with uncontrolled coagulopathy or bleeding disorder
  • Treatment with strong inhibitors or inducers within 14 days before the first dose of study drug; strong CYP3A inhibitors/inducers are not permitted during the study, including nutraceutical preparations, e.g., grapefruit juice and St John's wort; patients must have no prior history of amiodarone in the 6 months prior to the first dose of pevonedistat
  • Patient requiring chronic treatment with BCRP inhibitors (cyclosporine, eltrombopag)
  • History prior except:

    • Malignancy treated with curative intent and no known active disease present for >= 2 years prior to initiation of therapy on current study
    • Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease
    • Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease
    • Asymptomatic prostate cancer managed with watch and wait strategy
    • Myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screening
  • Uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis or history of immune-mediated cytopenias are not exclusions)
  • History of (HIV) infection
  • Known surface antigen seropositive or known or suspected active Infection; Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load
  • Known cardiopulmonary disease defined as one of the following:

    • Unstable angina
    • Uncontrolled high blood pressure (ie, systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mm Hg )
    • Congestive heart failure ( [NYHA] class III or IV)
    • Myocardial infarction (MI) within 6 months prior to first dose (patients who had ischemic heart disease such as a (acute chest syndrome [ACS]), MI, and/or revascularization greater than 6 months before screening and who are without cardiac symptoms may enroll)
    • Cardiomyopathy
    • arrhythmia: 1) History of polymorphic ventricular fibrillation or torsade de pointes, 2) Permanent atrial fibrillation [a fib], defined as continuous a fib for >= 6 months, 3) Persistent a fib, defined as sustained a fib lasting > 7 days and/or requiring cardioversion in the 4 weeks before screening, 4) grade 3 a fib defined as symptomatic and incompletely controlled medically, or controlled with device (e.g. pacemaker), or ablation and 5) Patients with paroxysmal a fib or \< grade (Gr) 3 a fib for period of at least 6 months are permitted to enroll provided that their rate is controlled on a stable regimen
    • Implantable cardioverter defibrillator
    • Moderate to severe aortic and/or mitral stenosis or other valvulopathy (ongoing)
    • Pulmonary hypertension
    • Prolong rate (QTc) interval >= 500 msec. calculated according to institutional guidelines
    • (LVEF) \< 50% as assessed by echocardiogram or radionuclide angiography
  • Known moderate to severe (COPD), interstitial lung disease, and pulmonary fibrosis
  • Known hepatic cirrhosis or severe pre-existing hepatic impairment
  • Major surgery (requiring general anesthesia) within 14 days before the first dose of study drug or a scheduled surgery during study period
  • Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 before first dose of study drug
  • Inability to swallow and retain an oral medication; patients with clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, nausea, vomiting or any other condition that will interfere significantly with the absorption of ibrutinib
  • Active uncontrolled infection or severe infection disease (e.g., severe pneumonia, meningitis, septicemia, or methicillin resistant Staphylococcus aureus infection)
  • Any condition for which participation in the study is judged by the investigator to be detrimental to the patient with inter-current illness or psychiatric/social situations that would jeopardize compliance with study requirements
  • Female patients who intend to donate eggs (ova) during the course of this study or 4 months after receiving their last dose of study drug(s)
  • Male patients who intend to donate sperm during the course of this study or 4 months after receiving their last dose of study drug(s)
Terms in these criteria, in plain language(28)

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.

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

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.

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.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

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.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

COPD

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Treatment (pevonedistat, ibrutinib)

    Participants receive pevonedistat IV over 1 hour on days 1, 3, and 5, and ibrutinib PO daily on days 2-21 of course 1 and days 1-21 of subsequent courses. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Participants then receive only ibrutinib PO daily on days 1-21. Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.

    Drug: Ibrutinib · Other: Laboratory Biomarker Analysis · Drug: Pevonedistat · Other: Pharmacokinetic Study · Other: Pharmacological Study

Interventions

  • Given PO

    Also known as: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • Given IV

    Also known as: MLN4924, Nedd8-Activating Enzyme Inhibitor MLN4924

  • OtherPharmacokinetic Study

    Correlative studies

    Also known as: PHARMACOKINETIC, PK Study

  • OtherPharmacological Study

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Incidence of dose limiting toxicities (DLTs)

    Time frame: Up to 42 days

  2. Incidence of adverse events (AEs), serious AEs (SAEs), dose interruptions, reductions and dose intensity Common Terminology Criteria for Adverse Events version 4.03

    All adverse events will be tabulated and summarized by major organ category, grade, anticipation, and drug attribution. SAE specific incidence and exact 95% confidence interval will be provided where appropriate.

    Time frame: Up to 30 days after last course of treatment

Secondary outcomes

  1. Overall response rate (ORR) determined based on proportion of participants who achieve complete response (CR), with incomplete marrow recovery (CRi), partial response (PR), or nodular partial response (nPR)

    According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria in patients with chronic lymphocytic leukemia (CLL) and Lugano criteria in patients with non-Hodgkin lymphoma (NHL). The ORR, along with exact two-sided 95% confidence intervals, will be reported for the study.

    Time frame: Up to 1 year

  2. Event-free survival (EFS)

    Defined as the interval between the date of first study treatment and the date of objective signs of disease recurrence, subsequent anti-leukemic therapy, or death, whichever is first reported. The Kaplan-Meier product limit method will be used to estimate progression-free survival (PFS) of the median PFS and PFS rates at clinically relevant time points will be provided with the 95% confidence interval (CI).

    Time frame: From date of first study treatment until progression, start of anti-leukemic therapy, or death, assessed up to 4 years

07

Study locations

2 sites
08

References and documents

Publications

  • Torka P, Thiruvengadam SK, Chen L, Wang X, Chen C, Vuong D, Qin H, Muir A, Orand K, Borja I, Lynne Smith D, Herrera AF, Spurgeon SEF, Park B, Lewis LD, Hernandez-Ilizaliturri F, Xia Z, Danilov AV. Pevonedistat, a Nedd8-activating enzyme inhibitor, in combination with ibrutinib in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Blood Cancer J. 2023 Jan 11;13(1):9. doi: 10.1038/s41408-022-00763-w. PubMed 36631449 ↗
09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Nov 10, 2026
Primary completion
Nov 5, 2026→Oct 28, 2026 (actual)
Nov 10, 2026
Study completion
Nov 5, 2026→Oct 28, 2026 (actual)
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Active, not recruiting→Completed
    Primary completion Nov 5, 2026→Oct 28, 2026 (now actual)
    Study completion Nov 5, 2026→Oct 28, 2026 (now actual)
    + 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
NCT03479268
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Apr 27, 2018
Primary completion
Oct 28, 2026
Completion
Oct 28, 2026
Last update
Nov 10, 2026

Study contacts

Alexey Danilov
principal investigator · City of Hope Medical Center

Oversight

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

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This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Ibrutinib · Pevonedistat

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