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A Pilot Trial of AVD and Brentuximab Vedotin (SGN-35) in the Treatment of Stage III-IV HIV-associated Hodgkin Lymphoma — AMC-085  

HIV Infection Clinical Trial

Official title:
A Pilot Trial of AVD and Brentuximab Vedotin (SGN-35) in the Treatment of Stage III-IV HIV-associated Hodgkin Lymphoma

Clinical Trial Summary

This phase II trial studies the side effects and the best dose of brentuximab vedotin and combination chemotherapy work in treating patients with stage III-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth by finding cancer cells and causing them to die. 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 or by stopping them from dividing. Giving brentuximab vedotin together with combination chemotherapy may kill more cancer cells.

Clinical Trial Description

OUTLINE: This is a phase II study. Patients receive doxorubicin hydrochloride intravenously (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 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years. PRIMARY OBJECTIVE: • To establish an estimate of the two-year progression-free survival (PFS) for patients with HIV-associated stage III-IV Hodgkin lymphoma when treated using brentuximab vedotin plus the AVD chemotherapy regimen. SECONDARY OBJECTIVE: - To evaluate the toxicity of AVD and brentuximab vedotin with highly active antiretroviral therapy (HAART). - To estimate the partial response (PR) rate, complete response (CR) rate, overall survival (OS), and event free survival (EFS) at 2 and 5 years. - To evaluate the effect of AVD and brentuximab vedotin on CD4 and CD8 counts after cycle 1, 4, at the end of therapy, and every 3 months after treatment completion for one year. - To investigate the prognostic value of FDG-PET/CT scans at baseline, after cycle 2, and at treatment completion, with respect to 2-year progression free survival. - To evaluate HAART status at baseline and to correlate this with tumor response to therapy and OS and PFS. - To characterize the histologic subtypes in HIV-HL in the HAART era. - To assess the neurotoxicity of HAART in combination with AVD and brentuximab vedotin. - To evaluate effect of AVD and brentuximab vedotin on viral load after cycle 1, 4, at the completion of therapy, and every 3 months after treatment completion for one year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02298257
Study type Interventional
Source The Lymphoma Academic Research Organisation
Contact
Status Completed
Phase Phase 2
Start date June 2015
Completion date August 8, 2022
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