drugset / Trial / NCT00416884

Flu,Alemtuzumab,and TBI Followed By Donor Stem Cell Chronic Phase CML

NCT00416884 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation (TBI) before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and alemtuzumab, and removing the T lymphocyte cells(T cells) from the donor cells before transplant, may stop this from happening. PURPOSE: This clinical trial is studying how well giving fludarabine, alemtuzumab, and total-body irradiation together with donor stem cell transplant and donor white blood cell (WBC) infusion works in treating patients with chronic phase chronic myelogenous leukemia (CML) that did not respond to previous imatinib mesylate.

Timeline

Start
2003-05
Primary completion
2008-03
Completion
2008-03

Outcome

Outcome not reported

Stopped (Enrollment): “Low enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Campath Monoclonal antibody 30 mg —
Subject Fludarabine Small molecule 30 mg/m2 —

Indications