41 Participants Needed

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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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

PG

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.
See 25 more

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.
See 6 more

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
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:
  • 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

Find a Clinic Near You

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+
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