Brentuximab Vedotin + Chemotherapy for Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a new treatment combining brentuximab vedotin and chemotherapy can effectively address Hodgkin's lymphoma in individuals with HIV. Brentuximab vedotin targets cancer cells and delivers a chemotherapy drug directly to them. The trial seeks to determine the optimal dosage and monitor for any side effects. It seeks participants diagnosed with stage II-IV Hodgkin's lymphoma, who have HIV, and have not yet received treatment for their lymphoma, except for brief initial therapy to manage urgent symptoms. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I have to stop taking my current medications for the trial?
You may need to stop taking certain medications before joining the trial. Specifically, if you are on strong CYP3A4 inhibitors or P-glycoprotein inhibitors, you must stop them at least 7 days before starting the trial. It's important to review all your medications with the study team to ensure they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that brentuximab vedotin is usually well-tolerated by patients with Hodgkin lymphoma. In past studies, patients with relapsed or difficult-to-treat Hodgkin lymphoma responded well to brentuximab vedotin, with response rates of 75% and 86%. These studies primarily assessed the treatment's effectiveness but also provided safety information.
Common side effects of brentuximab vedotin include low blood cell counts, nerve damage, and tiredness. However, most patients do not experience serious issues. Researchers are testing its effectiveness when combined with chemotherapy drugs like doxorubicin, vinblastine, and dacarbazine to determine if this combination can improve outcomes without causing excessive side effects.
This trial is in the early stages, focusing on safety and the appropriate dose. Although previous studies suggest the treatment may be safe, further research is needed to confirm this in different populations.12345Why do researchers think this study treatment might be promising?
Brentuximab vedotin is unique because it combines an antibody with a chemotherapy drug, creating an antibody-drug conjugate that specifically targets and destroys cancer cells. This is different from traditional chemotherapy, which attacks all rapidly dividing cells, healthy or cancerous. Researchers are excited about brentuximab vedotin for Hodgkin's lymphoma because it offers a more targeted approach, potentially reducing side effects and improving effectiveness. Additionally, when paired with chemotherapy agents like doxorubicin, vinblastine, and dacarbazine, it has the potential to enhance treatment outcomes by attacking the cancer on multiple fronts.
What evidence suggests that this trial's treatments could be effective for HIV-associated Hodgkin lymphoma?
Research has shown that brentuximab vedotin, when combined with chemotherapy, yields promising results for treating Hodgkin's lymphoma. In this trial, participants will receive a combination of brentuximab vedotin with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine. One study found that 93.9% of patients were still alive six years after receiving this treatment, meaning nearly 94 out of 100 patients survived for six years post-treatment. Brentuximab vedotin targets specific cancer cells and delivers chemotherapy directly to them, enhancing the effectiveness of cancer cell destruction. Additionally, real-world evidence indicates that this treatment reduces the chance of cancer returning in high-risk patients after a stem cell transplant. These findings suggest that brentuximab vedotin, combined with chemotherapy, can be an effective treatment option for Hodgkin's lymphoma.36789
Who Is on the Research Team?
Paul G Rubinstein
Principal Investigator
AIDS Malignancy Consortium
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
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
What Are the Treatments Tested in This Trial?
Interventions
- Brentuximab Vedotin
- Dacarbazine
- Doxorubicin Hydrochloride
- Vinblastine
Brentuximab Vedotin is already approved in United States, European Union for the following indications:
- Hodgkin lymphoma
- Systemic anaplastic large cell lymphoma
- Primary cutaneous anaplastic large cell lymphoma
- CD30-expressing mycosis fungoides
- Peripheral T-cell lymphoma
- 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
The Lymphoma Academic Research Organisation
Collaborator