Ibrutinib + Brentuximab Vedotin for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Alex Herrera

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well ibrutinib and brentuximab vedotin work in treating patients with Hodgkin lymphoma that has returned (relapsed) or does not respond to treatment (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as brentuximab vedotin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib together with brentuximab vedotin may be a better treatment for Hodgkin lymphoma.

Research Team

Alex Herrera

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults with relapsed or refractory Hodgkin lymphoma, who have tried at least one treatment before. They must have a certain level of blood cells and organ function, agree to use contraception, and not be pregnant. People can't join if they weigh less than 40 kg, have severe illnesses or infections, are on certain drugs that affect the liver enzyme CYP3A4/5, or had bad reactions to similar drugs.

Inclusion Criteria

My hemoglobin level is at least 8.5 g/dl, and I haven't used growth factors in the last 14 days.

My cancer can be measured and is larger than 1.5 cm on a CT or PET scan.

My platelet count is at least 50,000/uL, and I haven't used growth factors in the last 14 days.

Exclusion Criteria

I haven't had a heart attack in the last 6 months and don't have severe heart issues.

I weigh 40 kg or less.

I don't have any severe illnesses that could risk my safety in the study.

Treatment Details

Interventions

• Brentuximab Vedotin (Monoclonal Antibodies)
• Ibrutinib (Kinase Inhibitor)

Trial Overview The trial tests combining Ibrutinib (which blocks enzymes for cell growth) with Brentuximab Vedotin (an antibody that helps the immune system attack cancer). It's for patients whose Hodgkin lymphoma has come back after treatment or hasn't responded to previous treatments.

Participant Groups

Group I: Arm II: Ibrutinib 560 mg PO QD + BV 1.8 mg/kg IV Q21 days Experimental Treatment 2 Interventions

Patients receive ibrutinib 560 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I: Ibrutinib 420 mg PO QD + BV 1.8 mg/kg IV Q21 days Experimental Treatment 2 Interventions

Patients receive ibrutinib 420 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School