Study of Stem Cell Transplantation for Hematologic Malignancies Using Clofarabine and Busulfan Regimen

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with Busulfan as a full-intensity conditioning (Clo/BU4 regimen) prior to transplant and then (Phase II) to investigate the safety and effectiveness of this regimen as a conditioning for stem cell transplant in the treatment of aggressive hematologic malignancies in subjects where more conventional approaches are failing.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Busulfan; Clofarabine

Criteria

Inclusion Criteria:

Disease Criteria

• Acute leukemia or chronic myelogenous leukemia in blastic crisis or accelerated phase, not in remission at the time of transplant

• Myelodysplastic syndrome, with more than 5% blasts in bone marrow at the time of transplant

• Hodgkin and Non-Hodgkin Lymphomas: Not in CR in PET scan or CT scan before transplant, or relapsed within 1 year from previous remission

• CLL not in remission

• Multiple Myeloma, not in remission

• Suitable donor available (related or unrelated)

Age, Organ Function Criteria

• Age: ≤ 70 years

• Cardiac: LV Ejection Fraction ≥ 40% by MUGA or Echocardiogram

• Pulmonary: FEV1 and FVC ≥ 40% predicted, and DLCO (corrected for hemoglobin) ≥ 40% of predicted

• Renal: Adult population: serum creatinine ≤ 1.0 mg/dL (if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation)

• Renal: Pediatric population: serum creatinine clearance ≥ 90 ml/min/1.73 m2 as calculated by the Schwartz formula for estimated GFR

• Hepatic: serum total bilirubin ≤ 2.0 mg/dl and AST / ALT ≤ ULN x 4

• Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

• Other active life-threatening cancer requiring treatment other than allo-HSCT

• HIV1 or HIV2 positive

• Uncontrolled medical or psychiatric disorder

• Uncontrolled viral or fungal infection

• Active CNS leukemia

• Non-compliant to medications

• No appropriate caregivers identified