Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma
NCT03712202 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155
Last updated 2024-11-06
Summary
This phase II trial studies how well brentuximab vedotin and nivolumab work in treating patients with stage I-II classic Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Conditions
- Ann Arbor Stage I Hodgkin Lymphoma
- Ann Arbor Stage I Mixed Cellularity Classic Hodgkin Lymphoma
- Ann Arbor Stage I Nodular Sclerosis Classic Hodgkin Lymphoma
- Ann Arbor Stage IA Hodgkin Lymphoma
- Ann Arbor Stage IB Hodgkin Lymphoma
- Ann Arbor Stage II Hodgkin Lymphoma
- Ann Arbor Stage IIA Hodgkin Lymphoma
- Ann Arbor Stage IIB Hodgkin Lymphoma
- Classic Hodgkin Lymphoma
- Lymphocyte-Rich Classic Hodgkin Lymphoma
- Ann Arbor Stage I Lymphocyte-Depleted Classic HL
- Ann Arbor Stage II Lymphocyte-Depleted Classic HL
- Ann Arbor Stage II Mixed Cellularity Classic HL
- Ann Arbor Stage II Nodular Sclerosis Classic HL
Interventions
- DRUG
-
Bleomycin
Given IV
- DRUG
-
Brentuximab Vedotin
Given IV
- DRUG
-
Dacarbazine
Given IV
- DRUG
-
Doxorubicin
Given IV
- BIOLOGICAL
-
Given IV
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- DRUG
-
Vinblastine
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Alex F Herrera · City of Hope Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-28
- Primary Completion
- 2024-12-23
- Completion
- 2024-12-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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