Overview

Decitabine and Peripheral Stem Cell Transplantation in Treating Patients Who Have Relapsed Following Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

Status:
Completed
Trial end date:
2002-03-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Peripheral stem cell transplantation may be an effective treatment for leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed following bone marrow transplantation. PURPOSE: Phase I/II trial to study the effectiveness of decitabine and peripheral stem cell transplantation in treating patients who have leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed after bone marrow transplantation.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Azacitidine
Cyclosporine
Cyclosporins
Decitabine
Lenograstim
Criteria
DISEASE CHARACTERISTICS: Acute leukemia, myelodysplastic syndromes or chronic myelogenous
leukemia (CML) in accelerated phase or blast crisis and relapsed within 1 year after
allogeneic bone marrow transplantation Must not be candidates for second course of high
dose chemoradiotherapy

PATIENT CHARACTERISTICS: Age: 60 and under Performance status: Zubrod 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL Renal:
Creatinine less than 2 mg/dL Cardiovascular: Greater than 40% ejection fraction per MUGA
scan or ECHO Other: Not pregnant No serious intercurrent illness No active CNS disease Must
be ineligible for protocols of higher priority No active acute graft vs host disease (GVHD)
greater than grade 2 or extensive chronic GVHD No active uncontrolled infection Original
marrow donor must undergo filgrastim primed peripheral blood stem cell collection

PRIOR CONCURRENT THERAPY: See Disease Characteristics