Brentuximab Vedotin + Chemotherapy for Hodgkin's Lymphoma

Recruiting at 29 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Cancer Institute (NCI)

Must be taking: Antiretrovirals

Must not be taking: Zidovudine, Ritonavir, others

Disqualifiers: Pregnancy, Uncontrolled infection, Cirrhosis, others

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

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

Compensation: Varies

Number of Visits: 32

Duration: 24 weeks

41 Participants Needed

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.

Research Team

Paul G Rubinstein

Principal Investigator

AIDS Malignancy Consortium

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

HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL

Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 western blot confirmation or HIV rapid multispot antibody differentiation assay

My bilirubin levels are within the safe range for the study.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive doxorubicin hydrochloride, vinblastine sulfate, dacarbazine, and brentuximab vedotin intravenously on days 1 and 15, repeating every 28 days for up to 6 cycles

24 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion every 3 months for 2 years and then every 6 months for 3 years

5 years

20 visits (in-person)

Treatment Details

Interventions

• Brentuximab Vedotin
• Dacarbazine
• Doxorubicin Hydrochloride
• Vinblastine

Trial Overview 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.

Participant Groups

Group I: Treatment (brentuximab and combination chemotherapy) Experimental Treatment 5 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:

• 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?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

The Lymphoma Academic Research Organisation

Collaborator

Trials

58

Recruited

20,400+