MedTrace Logo

Non-Myeloablative Allogeneic Stem Cell Transplantation

NCT00525876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2011-12-07

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

Cyclophosphamide

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)

DRUG

Fludarabine

30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)

DRUG

Rituximab

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.

DRUG

Alemtuzumab

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)

PROCEDURE

Allogeneic Stem Cell Infusion

Infusion of stem cells.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Issa F. Khouri, MD, BS · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00525876 on ClinicalTrials.gov