Pevonedistat + Ibrutinib for CLL and Non-Hodgkin Lymphoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen ByAlexey Danilov

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

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

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

Exclusion Criteria

I cannot swallow or keep down oral medication.

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

I have severe liver problems or cirrhosis.

My cancer has spread to my brain or spinal cord.

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

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

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

I have a known heart or lung condition.

I do not have any severe or uncontrolled infections.

Participant Groups

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.

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.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: