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Tyrosine kinase inhibitor

Pevonedistat + Ibrutinib for CLL and Non-Hodgkin Lymphoma

Phase 1

Waitlist Available

Led By Alexey Danilov

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with CLL/SLL must demonstrate active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment

Patients with NHL and with B-cell prolymphocytic leukemia must have an indication for treatment

Must not have

Inability to swallow and retain an oral medication

Known moderate to severe chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary fibrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first study treatment until progression, start of anti-leukemic therapy, or death, assessed up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the side effects and best dose of pevonedistat when given with ibrutinib for people with CLL or NHL that has returned or stopped responding to other treatments.

Who is the study for?

This trial is for people with certain types of blood cancers like CLL or non-Hodgkin lymphoma that have not improved with other treatments. Participants must be in fairly good health, able to perform daily activities (ECOG 0-2), and meet specific lab criteria indicating their organs are functioning well. They should agree to use contraception and not donate eggs or sperm during the study.

What is being tested?

The trial is testing the combination of two drugs, Pevonedistat and Ibrutinib, to find out the safest doses and how they affect cancer cell growth. It's a phase I study which means it's early in the clinical trials process focusing on safety rather than effectiveness.

What are the potential side effects?

Possible side effects include reactions related to blocking enzymes needed for cell growth which may affect normal cells as well as cancer cells. Specific side effects aren't listed but could range from mild symptoms like nausea to more serious issues affecting organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My CLL/SLL requires treatment based on specific health criteria.

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I have NHL or B-cell leukemia and need treatment.

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My cancer involves swollen lymph nodes or affects areas outside the lymph nodes, not including LPL or CLL.

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I can care for myself and am expected to live more than 3 months.

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I have had specific chemoimmunotherapy for my type of blood cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow or keep down oral medication.

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I have a serious lung condition like COPD, lung scarring, or fibrosis.

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I have severe liver problems or cirrhosis.

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My cancer has spread to my brain or spinal cord.

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I am on a full dose of blood thinners or have a bleeding disorder that is not under control.

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I haven't had major surgery in the last 2 weeks and don't plan any during the study.

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I have had a stem cell transplant and am experiencing complications.

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I have a known heart or lung condition.

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I do not have any severe or uncontrolled infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first study treatment until progression, start of anti-leukemic therapy, or death, assessed up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first study treatment until progression, start of anti-leukemic therapy, or death, assessed up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first study treatment until progression, start of anti-leukemic therapy, or death, assessed up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Event-free survival (EFS)

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pevonedistat, ibrutinib)Experimental Treatment5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~2060

Pevonedistat

2021

Completed Phase 3

~770