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Complete title: Multi-center, single arm Phase II Study of Myeloablative Allogeneic Stem Cell Transplantation for non-remission Acute Myeloblastic Leukemia (AML) using Clofarabine and Busulfan x 4 (CloBu4) regimen
|Research Study Number||7617|
|Principal Investigator||Pamela Becker, MD, PhD|
Research Study Description
From the investigators earlier study, it is suggested that replacing Fludarabine of standard FluBu4 regimen by Clofarabine (a related drug with much more potent anti-leukemia effect) in the transplant conditioning regimen may potentiate the anti-tumor activity of the conditioning regimen without adding significant toxicity, a goal of new conditioning regimen development.
The investigators expect to enroll a total of 75 patients from about fifteen sites. The investigators main objective is to confirm both the safety and efficacy as measured by one-year overall survival, of the CloBu4 combination as full intensity conditioning for non-remission acute myelogenous leukemia.
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- AML not in remission at the time of transplant
- "Not in remission" is defined as "greater than 5.0% bone marrow blasts by aspirate morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration.
- For primary induction failure patients: Patients must have failed at least 2 induction regimens.
- For patients with relapsed disease: Patients who relapse more than 6 months after preceding remission must fail at least one reinduction regimen to be eligible. For patients in whom the preceding remission is equal to or shorter than 6 months duration, no re-induction regimen is required to qualify for this protocol.
- If the pre-transplant bone marrow aspirate and biopsy are hypoplastic (less than 10% cellularity), and blast percentages cannot be determined, the patient is eligible if the preceding bone marrow met the above criteria.
- Patients with peripheral circulating blasts or patients with extramedullary leukemia are eligible if bone marrow aspirate and biopsy meets the above criteria. Age and Organ Function Criteria
- Age: 2 to 65 years in age.
- Cardiac: LVEF = 40% by MUGA (Multi Gated Acquisition) scan or echocardiogram.
- Pulmonary: FEV1 and FVC capacity) = 40% predicted, DLCO (corrected for hemoglobin) = 40% of predicted.
- Children who are unable to cooperate for pulmonary function tests (PFTs), must have no evidence of dyspnea at rest, no exercise intolerance, and not require supplemental oxygen therapy.
- Renal: Age equal to or older than 12: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula. Age younger than 12: Either estimated or measured CrCl should be greater than 90 ml/min/1.73m2. For estimation, Schwartz formula will be used.
- Hepatic: Serum bilirubin = 1.5 x upper limit of normal (ULN); (AST)/ ALT = 2.5 x ULN; Alkaline phosphatase = 2.5 x ULN
- Performance status: Karnofsky = 70%., or Lansky=70% Consent: All patients must sign informed consent
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Non-compliant to medications.
- No appropriate caregivers identified.
- HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive
- Active life-threatening cancer requiring treatment other than AML
- Uncontrolled medical or psychiatric disorders.
- Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection
- Active central nervous system (CNS) leukemia
- Preceding allogeneic HSCT
- Receiving intensive chemotherapy within 21 days of registration.
- Patients with preceding primary myelofibrosis
- Peripheral blasts > 10,000/µL at the time of registration
Other exclusion criteria may apply.
Hematologic Malignancies; Leukemia; Myelodysplastic and Myeloproliferative Syndromes (MDS and MPD)
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