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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
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
Conditions
Interventions
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
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
gene expression analysis
Peripheral blood draw on day -9 and day -4 prior to transplant
reverse transcriptase-polymerase chain reaction
Peripheral blood draw on day -9 and day -4 prior to transplant
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
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.
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