Safety and Efficacy of Campath in Nonmyeloablative Transplantation

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00038844
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Campath-1 H (Alemtuzumab) — DRUG
    Starting Dose of 15 mg by vein daily, 3 days in a row.
  • Fludarabine — DRUG
    30 mg/m2 by vein daily, 3 days in a row.
  • Cyclophosphamide — DRUG
    1 gm/m2 by vein daily, 3 days in a row.
  • Rituximab — DRUG
    375 mg/m2 by vein, given (to some patients only, based on the subtypes of lymphomas) eight days before the transplant and then weekly for a total of 4 doses.

Study Details

Objective of the low-dose transplant regimen must produce the following effects: 1. Suppression of the patient's immune system to prevent rejection of the donor cells; 2. Control of the lymphoma. The pretransplant regimen must suppress the lymphoma sufficiently to prevent marked progression of the tumor and allow time for the GVT effect to occur.

Key Dates

Start date
Jun 30, 2001
Status verified
Oct 2011
Primary completion
Dec 31, 2007
Completion
Sep 30, 2010

Study Design

Enrollment
65 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Campath in Nonmyeloablative Transplantation
    Campath-1 H Starting Dose of 15 mg by vein daily, 3 days in a row + Fludarabine 30 mg/m2 by vein daily, 3 days in a row + Cyclophosphamide 1 gm/m2 by vein daily, 3 days in a row + Rituximab 375 mg/m2 by vein, given 8 days before transplant then weekly for 4 total doses.

Primary Outcome Measure

Number of Participants Surviving 100 days post-transplant [ Time Frame: 30 Day Engraftment (Baseline) to 100 Days post-transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
U.T.M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
U.T.M.D. Anderson Cancer Center· Houston, TX

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