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

CompletedPhase 1, Phase 2

Sponsor: University of Michigan Rogel Cancer Center

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

Interventions: Clofarabine/Busulfan x 4, Peripheral blood stem cell transplant, Total Lymphoid Irradiation

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: — to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Ann Arbor, Michigan, United States