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

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
LeukemiaMyelodysplastic Syndromes
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

Trial Locations (1)

91010-3000

City of Hope Comprehensive Cancer Center, Duarte

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER

NCT00641030 - Clofarabine and High-Dose Melphalan Followed by Donor Stem Cell Transplant in Patients With Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Myelodysplastic Syndromes | Biotech Hunter | Biotech Hunter