Ibrutinib + Brentuximab Vedotin for Hodgkin's Lymphoma

Recruiting at 2 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: Warfarin, Strong CYP3A4/5 inhibitors

Disqualifiers: Uncontrolled illness, Active CNS disease, Recent stroke, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 24

Duration: Up to 8 months

39 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ibrutinib orally once daily and brentuximab vedotin intravenously every 21 days

Up to 8 months

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Every 3 months

Treatment Details

Interventions

• Brentuximab Vedotin
• Ibrutinib

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.

Brentuximab Vedotin is already approved in United States, European Union for the following indications:

Approved in United States as Adcetris for:

• Hodgkin lymphoma
• Systemic anaplastic large cell lymphoma
• Primary cutaneous anaplastic large cell lymphoma
• CD30-expressing mycosis fungoides
• Peripheral T-cell lymphoma

Approved in European Union as Adcetris for:

• Hodgkin lymphoma
• Systemic anaplastic large cell lymphoma
• Cutaneous T-cell lymphoma

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+