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COMPLETED
NCT00641030
PHASE1

Clofarabine and High-Dose Melphalan Followed by Donor Stem Cell Transplant in Patients With Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Myelodysplastic Syndromes

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

RATIONALE: Giving chemotherapy, such as clofarabine and melphalan, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with high-dose melphalan followed by a donor stem cell transplant in treating patients with acute myeloid leukemia, acute lymphocytic leukemia, or myelodysplastic syndromes.

Official title: A Phase I Study of Clofarabine Plus High Dose Melphalan as a Conditioning Regimen for Allogeneic Transplantation

Key Details

Gender

All

Age Range

1 Year - 120 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2007-07-27

Completion Date

2011-01-01

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

DRUG

clofarabine

Administered at the appropriate dose level(dose level one = 30 mg/m2, dose level two and three = 40 mg/m2)on days -9 to day -5 from transplant

DRUG

melphalan

Administered at the appropriate dose level (dose level one and two = 100 mg/m2, dose level three = 140 mg/m2) on day -4 from transplant

GENETIC

gene expression analysis

Peripheral blood draw on day -9 and day -4 prior to transplant

GENETIC

reverse transcriptase-polymerase chain reaction

Peripheral blood draw on day -9 and day -4 prior to transplant

OTHER

flow cytometry

Bone marrow aspirate and biopsy to confirm diagnosis prior to transplant, day -9 pre-transplant, day 30 post-transplant, day 100 post-transplant, 6 months post-transplant, one year post-transplant, then yearly through year 5 post-transplant

OTHER

laboratory biomarker analysis

Peripheral blood draw day -9 or earlier pre-transplant, day 14 post-transplant, day 30 post-transplant, day 60 post-transplant, day 100 post-transplant, 6 months and one year post-transplant.

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Infusion of allogeneic hematopoietic stem cells on day 0 of transplant

Locations (1)

City of Hope Comprehensive Cancer Center

Duarte, California, United States