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Safety and Efficacy of Campath in Nonmyeloablative Transplantation

NCT00038844 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2011-11-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Campath-1 H (Alemtuzumab)

Starting Dose of 15 mg by vein daily, 3 days in a row.

DRUG

Fludarabine

30 mg/m2 by vein daily, 3 days in a row.

DRUG

Cyclophosphamide

1 gm/m2 by vein daily, 3 days in a row.

DRUG

Rituximab

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2007-12-31
Completion
2010-09-30

Countries

  • United States

Study Locations

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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 NCT00038844 on ClinicalTrials.gov