Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab in Autologous Stem Cell Transplantation

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00591630
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Zevalin — DRUG
    (111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
  • Carmustine — DRUG
    300 mg/m\^2 by vein.
  • Etoposide — DRUG
    200 mg/m\^2 by vein every 12 hours.
  • Cytarabine — DRUG
    200 mg/m\^2 by vein every 12 hours.
  • Melphalan — DRUG
    140 mg/m\^2 by vein.
  • Rituximab — DRUG
    Arm 1, Arm 2 = 250 mg/m\^2 by vein; Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant; Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
  • Stem Cell Transplant — PROCEDURE
    Injection of stem cells (Autologous SCT)

Study Details

The goal of this clinical research study is to learn if the addition of 90Y Zevalin to BEAM chemotherapy (carmustine, etoposide, cytarabine, and melphalan) and rituximab is more effective than the combination of BEAM and rituximab alone in patients with lymphoma who receive a stem cell transplant.

Key Dates

Start date
Nov 14, 2007
Status verified
Jan 2021
Primary completion
Mar 5, 2020
Completion
Mar 5, 2020

Study Design

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

Arms

  • Active Comparator: Zevalin + BEAM + Rituximab +Stem Cell Transplant + Rituximab
    Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
  • Active Comparator: Zevalin + BEAM + Rituximab +Stem Cell Transplant
    Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant
  • Active Comparator: BEAM + Rituximab + Stem Cell Transplant + Rituximab
    BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
  • Active Comparator: BEAM + Rituximab + Stem Cell Transplant
    BEAM + Rituximab Followed by Stem Cell Transplant

Primary Outcome Measure

Number of Participants With a 2-Year Progression-Free Survival (PFS) [ Time Frame: 2 years (beginning day 30 after treatment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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University of Texas MD Anderson Cancer Center· Houston, TX

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