Status:
COMPLETED
Clofarabine and High-Dose Melphalan Followed by Donor Stem Cell Transplant in Patients With Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Myelodysplastic Syndromes
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
1-120 years
Phase:
PHASE1
Brief 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...
Detailed Description
OBJECTIVES: * To determine the maximum tolerated dose and toxicities of clofarabine when administered with high-dose melphalan as a conditioning regimen in patients undergoing allogeneic stem cell tr...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of one of the following:
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Myelodysplastic syndromes
- Disease meets 1 of the following criteria:
- In first complete remission (CR)
- In second CR
- In relapse
- No more than 50% blasts in bone marrow
- Not deemed eligible for standard transplantation regimens by the attending physician, or at high risk for relapse
- No suspected or proven CNS leukemia
- HLA-matched (6/6) sibling donor available
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 50-100%
- Glomerular filtration rate (pediatric patients) or creatinine clearance ≥ 60 mL/min OR serum creatinine \< 1.5 times upper limit of normal (ULN)
- Serum bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 2.5 times ULN
- LVEF ≥ 50% by ECHO or MUGA scan
- DLCO or FEV\_1 ≥ 40% predicted
- Not pregnant
- Negative pregnancy test
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing, active, or poorly controlled infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Poorly controlled pulmonary disease
- Psychiatric illness/social situation that would limit compliance with study requirement
- No active cytomegalovirus (CMV) or fungal disease
- HIV negative
- PRIOR CONCURRENT THERAPY:
- Recovered from prior intensive chemotherapy (pediatric patients)
- At least 100 days since prior autologous stem cell transplantation
- At least 100 days since prior radiotherapy administered as part of a transplantation conditioning regimen
- At least 4 weeks since prior chemotherapy
- At least 24 hours since prior hydroxyurea for blast count control
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00641030
Start Date
July 1 2007
End Date
January 1 2011
Last Update
June 15 2023
Active Locations (1)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000