Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT03233347
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Ann Arbor Stage I 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

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Brentuximab Vedotin — DRUG
    Given IV
  • Dacarbazine — DRUG
    Given IV
  • Doxorubicin — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Vinblastine — DRUG
    Given IV

Study Details

This phase II trial evaluates how well AVD (doxorubicin, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab may improve survival of patients with stage I-II Hodgkin lymphoma.

Key Dates

Start date
Oct 13, 2017
Status verified
Sep 2025
Primary completion
Jul 1, 2025
Completion
Jul 8, 2026

Study Design

Enrollment
82 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (combination chemotherapy, nivolumab)
    Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and dacarbazine IV over \>= 30 minutes, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET-positive then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. PET-positive patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. PET-negative patients receive nivolumab IV over 30 minutes on day 1 starting after AVD and BV treatment. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression free survival [ Time Frame: From registration, where progression is by computed tomography (CT)-based or positron emission tomography (PET)-CT based criteria, assessed at 3 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Mayo Clinic in RochesterRochesterMinnesota55905-
University of Nebraska Medical CenterOmahaNebraska68198-
Hackensack University Medical CenterHackensackNew Jersey07601-
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203-
University of Pennsylvania/Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
M D Anderson Cancer CenterHoustonTexas77030-
University of Washington Medical Center - MontlakeSeattleWashington98195-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAMayo Clinic in Rochester· Rochester, MNUniversity of Nebraska Medical Center· Omaha, NEHackensack University Medical Center· Hackensack, NJCarolinas Medical Center/Levine Cancer Institute· Charlotte, NCUniversity of Pennsylvania/Abramson Cancer Center· Philadelphia, PA

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