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

Completed · Phase 1/Phase 2

Conditions studied: Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT00556452

Run by

University of Michigan Rogel Cancer Center

People needed

46

Starts

2007-10-01

Expected to finish

2012-09-01

Last updated by the study team

2017-12-05

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• University of Michigan, Department of Internal Medicine, Blood and Marrow Transplant Program — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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