Phase 2
Completed N=46
Study of Stem Cell Transplantation for Hematologic Malignancies Using Clofarabine and Busulfan Regimen
Source: ClinicalTrials.gov NCT00556452 ↗Enrolled (actual)
46
Serious AEs
50.0%
Results posted
Jan 2015
Primary outcomePrimary: Regimen Related Toxicities — 56; 70; 4; 10 toxicities
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Regimen Related Toxicities |
56; 70; 4; 10; 8; 11 | — |
| PRIMARY One-year Overall Survival Rate for AML |
48 | — |
| SECONDARY Two-year Overall Survival for All Cases. |
28 | — |
| SECONDARY Five Year Overall Survival for All Cases |
6 | — |
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
Data sourced from ClinicalTrials.gov (NCT00556452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.