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Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma

NCT01771107 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-08-15

Study results available
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Summary

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.

Conditions

  • AIDS-Related Hodgkin Lymphoma
  • Ann Arbor Stage II Hodgkin Lymphoma
  • Ann Arbor Stage IIA Hodgkin Lymphoma
  • Ann Arbor Stage IIB Hodgkin Lymphoma
  • Ann Arbor Stage III Hodgkin Lymphoma
  • Ann Arbor Stage IIIA Hodgkin Lymphoma
  • Ann Arbor Stage IIIB Hodgkin Lymphoma
  • Ann Arbor Stage IV Hodgkin Lymphoma
  • Ann Arbor Stage IVA Hodgkin Lymphoma
  • Ann Arbor Stage IVB Hodgkin Lymphoma
  • Classic Hodgkin Lymphoma
  • HIV Infection

Interventions

DRUG

Brentuximab Vedotin

Given IV

DRUG

Dacarbazine

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Pharmacological Study

Correlative studies

DRUG

Vinblastine

Given IV

Sponsors & Collaborators

  • The Lymphoma Academic Research Organisation

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Paul G Rubinstein · AIDS Malignancy Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-08
Primary Completion
2021-10-15
Completion
2024-03-21

Countries

  • United States
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01771107 on ClinicalTrials.gov