Combination Chemotherapy With or Without Rituximab in Treating Participants With Stage III-IV Classic Hodgkin Lymphoma

Part of paid clinical trials in Miami, Florida.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00654732
Phase
PHASE2
Status
Completed

Conditions

  • Classic Hodgkin Lymphoma
  • Lugano Classification Stage III Hodgkin Lymphoma AJCC v8
  • Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8

Eligibility Criteria

Sex
ALL
Age
17 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bleomycin — DRUG
    Given IV
  • Dacarbazine — DRUG
    Given IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Rituximab — BIOLOGICAL
    Given IV
  • Vinblastine — DRUG
    Given IV

Study Details

This phase II trial studies how well combination chemotherapy with or without rituximab works in treating participants with stage III-IV classic Hodgkin lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab with combination chemotherapy may work better in treating participants with classic Hodgkin lymphoma.

Key Dates

Start date
Mar 19, 2008
Status verified
Feb 2020
Primary completion
Sep 5, 2018
Completion
Sep 5, 2018

Study Design

Enrollment
58 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (rituximab, combination chemotherapy)
    Participants receive rituximab intravenously IV over 7 hours on days 1, 8, 15, and 22 of course 1 and on days 1 and 8 of course 2. Participants also receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine IV over 1 hour on days 1 and 15. Treatment with ABVD repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm B (combination chemotherapy)
    Participants receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine as in Arm A.

Primary Outcome Measure

Event-free Survival (EFS) Rate [ Time Frame: From the start of study treatment up to 3 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
Rush University Medical CenterChicagoIllinois60612-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Miami, FL

By research site
University of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLRush University Medical Center· Chicago, ILMemorial Sloan Kettering Cancer Center· New York, NYM D Anderson Cancer Center· Houston, TX

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