Non-Myeloablative Allogeneic Stem Cell Transplantation

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00525876
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Matched Donors: 750 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine. Unrelated or Mismatched Donors: 1000 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)
  • Fludarabine — DRUG
    30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)
  • Rituximab — DRUG
    Matched Donors: 375 mg/m\^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation. Unrelated/Mismatched Donors: 375 mg/m\^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0) For development of disease progression or no response, immunomanipulation with Rituximab 375 mg/m\^2 given intravenously, then 1000 mg/m\^2 given intravenously weekly for 3 weeks, and taper off Tacrolimus dose over 2 weeks. DLI = Donor Lymphocyte Infusion/Immunomodulation Post Transplantation Immunomodulation for patients with lymphoid Malignancies: 375 mg/m\^2 then 1000 mg/m\^2 weekly x 3 if immunomanipulation is undertaken for persistent disease.
  • Alemtuzumab — DRUG
    Unrelated/Mismatched Donors: 15 mg per day given intravenously days 1 through 3 after transplantation. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)
  • Allogeneic Stem Cell Infusion — PROCEDURE
    Infusion of stem cells.

Study Details

1. To determine the safety and efficacy of non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for patients with advanced or recurrent mantle cell lymphoma. 2. To determine factors associated with response and durable remission in patients receiving rituximab, cyclophosphamide, and fludarabine in preparation for allogeneic stem cell transplantation.

Key Dates

Start date
Jan 31, 2005
Status verified
Nov 2011
Primary completion
Sep 30, 2010
Completion
Sep 30, 2010

Study Design

Enrollment
49 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Matched Sibling Transplant
    Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
  • Experimental: Allo MUD & MM
    Allo MUD \& MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.

Primary Outcome Measure

Overall Survival at 100 Days Post Transplant (Number of Surviving Participants) [ Time Frame: 100 days post transplant ]

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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