Clinical trial · Interventional
Study of Stem Cell Transplantation for Hematologic Malignancies Using Clofarabine and Busulfan Regimen
Phase I/II Study of Myeloablative Allogeneic Stem Cell Transplantation for Aggressive Hematologic Malignancies Using Clofarabine and Busulfan x 4 (Clo/BU4) Regimen
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine/Busulfan x 4 | Drug | — | UNRESOLVED |
| Peripheral blood stem cell transplant | Procedure | — | UNRESOLVED |
| Total Lymphoid Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clo/BU4
- description
- Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment. After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.
- interventionNames
- Drug: Clofarabine/Busulfan x 4
- Procedure: Peripheral blood stem cell transplant
- Radiation: Total Lymphoid Irradiation
Primary outcomes (2)
- measure
- Regimen Related Toxicities
- timeFrame
- two years
- description
- The incidence of non-hematological toxicities (Common Terminology Criteria for Adverse Events (CTCAE) 3.0) from initiation of conditioning to Day + 30 or toxicities after day +30, possibly, probably or definitely related to conditioning for all patients treated with Clofarabine (independent of dose level).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMagenau J, Tobai H, Pawarode A, Braun T, Peres E, Reddy P, Kitko C, Choi S, Yanik G, Frame D, Harris A, Erba H, Kujawski L, Elenitoba-Johnson K, Sanks J, Jones D, Paczesny S, Ferrara J, Levine J, Mineishi S. Clofarabine and busulfan conditioning facilitates engraftment and provides significant antitumor activity in nonremission hematologic malignancies. Blood. 2011 Oct 13;118(15):4258-64. doi: 10.1182/blood-2011-06-358010. Epub 2011 Aug 12. PMID 21841163