Status:
COMPLETED
Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Acute Myelogenous Leukemia
Eligibility:
All Genders
55-70 years
Phase:
PHASE2
Brief Summary
The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates \< 20% reported. Younger patients with AML in first comple...
Eligibility Criteria
Inclusion
- For Study Registration:
- Age 55 - 70 years.
- Subjects diagnosed with AML (\> 20% myeloblasts).
- For Proceeding to Transplant:
- Subjects must be in either complete remission (CR) or partial remission (PR) within 14 days prior to admission.
- Subjects must be \> 21 days since completion of prior systemic chemotherapy or radiation therapy (including craniospinal XRT), prior to admission .
- Organ function requirements for a reduced intensity (FluBu2) regimen (must be met within 21 days of admission):
- Cardiac: LV Ejection Fraction \> 40% on MUGA or Echocardiogram.
- Pulmonary: FEV1 and FVC \> 40% predicted, DLCO \> 40% of predicted.
- Renal: Serum creatinine \< 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH).
- Hepatic: serum total bilirubin \< 3.0 mg/dl and AST / ALT \< 4x ULN
- Karnofsky \> 60%.
- Organ function requirements for a full intensity (FluBu4) regimen (must be met within 21 days of admission):
- Cardiac: LV Ejection Fraction \> 40% on MUGA or Echocardiogram.
- Pulmonary: FEV1 and FVC \> 50% predicted, DLCO (corrected for hemoglobin) \> 50% of predicted.
- Renal: serum creatinine \< 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH)
- Hepatic: serum total bilirubin \< 3.0 mg/dl and AST / ALT \< 4x ULN.
- Karnofsky \> 60%.
Exclusion
- For Study Registration:
- Subjects with M3 AML (FAB classification)
- For Proceeding to Transplant:
- Subjects who exhibit signs of progressive disease (\> 20% blasts) within 14 days prior to admission for transplant
- Patients with an uncontrolled viral or fungal infection within the prior 28 days.
- Patients who are HIV1 or HIV2 positive.
- Uncontrollable medical or psychiatric disorder
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00623935
Start Date
March 1 2007
End Date
November 1 2015
Last Update
April 8 2016
Active Locations (1)
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1
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109