Abexinostat + Ibrutinib for Lymphoma

Recruiting at 8 trial locations

Overseen By Gilles Salles, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Ibrutinib, HDAC inhibitors

Disqualifiers: Active CNS disease, Cardiovascular disease, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if combining abexinostat and ibrutinib can safely stop cancer growth in patients by blocking enzymes and proteins that help cancer cells grow and survive. Ibrutinib is a medication approved for treating various cancers.

Who Is on the Research Team?

Gilles Salles, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults with certain types of lymphoma (Diffuse Large B-cell or Mantle Cell) who've had at least one prior treatment and are not eligible for a stem cell transplant. They must have measurable cancer, be in relatively good health, able to take oral meds, and agree to birth control measures. Excludes those with recent major surgery, active infections like hepatitis C/B, other cancers within 5 years except specific non-threatening types, uncontrolled heart conditions, or if they've been treated with similar drugs before.

Inclusion Criteria

I had a stem cell transplant over 6 months ago, am not on recent immunosuppression, and don't have active graft versus host disease.

I can follow the study's schedule and requirements.

My hemoglobin level is at least 8.0 g/dL despite having bone marrow cancer involvement.

Exclusion Criteria

I have been tested for Hepatitis B and do not have an active infection.

I have been treated with ibrutinib or an HDAC inhibitor before.

Patient has a history of non-compliance to medical regimen or inability to grant consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abexinostat and ibrutinib. Ibrutinib is administered once daily on a 28-day cycle, and abexinostat is administered orally twice daily for 7 days a week every other week on a 28-day cycle.

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abexinostat
• Ibrutinib

Trial Overview The trial is testing the safety of different doses of abexinostat combined with ibrutinib to see if this combination can halt the growth of Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma. The goal is to determine the best dose that works effectively without causing too many side effects.

How Is the Trial Designed?

Group I: Abexinostat and Ibrutinib Experimental Treatment 2 Interventions

The investigational agents to be used in this study are ibrutinib and abexinostat. Ibrutinib will be administered once daily on a 28-day cycle. Abexinostat will be administered orally twice daily (approximately 4-6 hours apart) for 7 days a week given every other week on a 28-day cycle.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Xynomic Pharmaceuticals, Inc.

Industry Sponsor

Trials

11

Recruited

1,200+