Rituximab and ABVD for Hodgkin's Patients

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00504504
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    375 mg/m\^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.
  • Adriamycin — DRUG
    25 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.
  • Bleomycin — DRUG
    10 U/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.
  • Vinblastine — DRUG
    6 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.
  • Dacarbazine (DTIC) — DRUG
    375 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Study Details

Primary Objective: \- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy. ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.

Key Dates

Start date
Mar 31, 2001
Status verified
May 2013
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

Enrollment
85 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab + ABVD Chemotherapy
    Rituximab 375 mg/m\^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m\^2 IV, Bleomycin 10 U/m\^2 IV, Vinblastine 6 mg/m\^2 IV, DTIC 375 mg/m\^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.

Primary Outcome Measure

5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD [ Time Frame: Baseline to 5 Years or until disease progression ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD . Anderson Cancer CenterHoustonTexas77030-

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By research site
UT MD . Anderson Cancer Center· Houston, TX

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