Brentuximab Vedotin + Chemotherapy for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+29 other locations

Overseen ByPaul G Rubinstein

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a chemotherapy drug called vedotin. Brentuximab attaches to CD30-positive cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin together with combination chemotherapy may kill more cancer cells.

Eligibility Criteria

This trial is for HIV-positive patients with stage II-IV Hodgkin lymphoma who haven't had certain treatments. They must be on antiretroviral therapy, have adequate organ function, and agree to use contraception. Excluded are those with severe neuropathy, central nervous system disease, cirrhosis, recent heart issues or other serious medical conditions.

Inclusion Criteria

I am not taking strong CYP3A inhibitors.

I have hepatitis C without cirrhosis and normal liver function tests.

My Hodgkin lymphoma is CD30-positive, not the nodular type.

My heart pumps blood well, with an ejection fraction of 50% or higher.

My kidney function is normal, with creatinine levels at or below 1.5 mg/dL or clearance above 60 mL/min if higher.

I am taking medication for low blood cell counts due to HIV.

I have stopped taking certain medications a week before starting chemotherapy.

I have records of receiving HIV treatment from a licensed healthcare provider.

I am taking strong medications for HIV.

I am not taking any P-glycoprotein inhibitors.

My condition is at stage II, III, or IV according to the Ann Arbor system.

Exclusion Criteria

I have a condition affecting my brain or spinal cord.

I have never had the JC virus or PML.

I do not have cirrhosis.

I experience significant numbness or pain in my hands or feet.

I have never received anthracycline therapy.

My MRI shows my brain disease is getting worse.

I am not pregnant or breastfeeding, confirmed by a test if applicable.

Participant Groups

The trial tests brentuximab vedotin combined with chemotherapy (doxorubicin hydrochloride, vinblastine sulfate, dacarbazine) in treating HIV-associated Hodgkin lymphoma. It aims to determine the best dose of brentuximab and how well it works alongside standard chemo drugs.

1Treatment groups

Experimental Treatment

Group I: Treatment (brentuximab and combination chemotherapy)Experimental Treatment5 Interventions

Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles 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: