Clinical trial · Interventional
Study of Stem Cell Transplant for Leukemia and Myelodysplastic Syndromes Using Clofarabine and Busulfan Regimen
Phase II Trial of Clofarabine With Parenteral Busulfan (Busulfex®) Followed by Allogeneic Related or Unrelated Donor Transplantation for the Treatment of Hematologic Malignancies and Diseases
NCT00852163CI-TRIAL-00009881completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to determine whether Clofarabine in combination with Busulfan is effective as a preparative transplant regimen for the treatment of leukemia and myelodysplastic syndromes
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine with Busulfan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clofarabine with Busulfan
- description
- Clofarabine 40 mg/m2 IV QD × 5 days Busulfan (Busulfex™) 3.2 mg/kg IV QD × 2 days
- interventionNames
- Drug: Clofarabine with Busulfan
Primary outcomes (1)
- measure
- Disease free survival at one and two year
- timeFrame
- At 1 year and 2 Year
Secondary outcomes (4)
- measure
- Incidence of hematopoietic engraftment
- timeFrame
- 100 days
- measure
- Incidence and severity of acute toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Disease Criteria: * Acute myelogenous leukemia (AML) * Acute lymphocytic leukemia (ALL) * Myelodysplastic syndromes (MDS) Refractory anemia (RA) with adverse cytogenetics (SWOG criteria) or beyond (RAEB, RAEB-T, AML) * Other Myeloproliferative Disorders Myelofibrosis, Agnogenic Myeloid Metaplasia, Chronic Myelomonocytic Leukemia (CMML) * Chronic lymphocytic leukemia (CLL) High risk or advanced disease Other Inclusion Criteria: * 18 years of age or older * Related or unrelated donor with HLA criteria as follows: * Related donors: a serologic equivalent HLA Class I (A, B, and C) and Class II DRB1 or DQB1 matched donor OR a donor who is a single 1 antigen mismatched for A, B, C, DRB1, or DQB1 loci * Unrelated donors: sequence-based typing fully matched A, B, C, DRB1, and DQB1 allele-matched donor OR a donor who is no greater than 1 antigen mismatched for A, B, C, DRB1, or DQB1 loci * Able to provide valid informed consent. * Female patients must have a negative serum pregnancy test within 2 weeks prior to enrollment. * Male and female patients must use an effective contraceptive method during the study and for up to 12 months after study treatment. Exclusion Criteria: Organ Function Criteria: * Cardiac: symptomatic coronary artery disease or ejection fraction \<45% or uncontrolled cardiac failure * Pulmonary: FEV1 or DLCO (corrected) \<50% of predicted values and/or receiving continuous supplementary oxygen * Hepatic: Bilirubin ≥ 1.2 mg/dL or AST/ALT ≥ 3x upper limit of normal (ULN) unless the liver is involved with malignant disease * Renal: creatinine clearance \< 60 mL/min (24-hour urine collection) or \<50 mL/min (Glofil test) * Karnofsky score \<60% * Active CNS disease * Prior hematopoietic transplantation (autologous or allogeneic) \<6 months prior to study entry * Use of investigational agents less than or equal to 30 days before study entry. * Life threatening, or clinically significant infection * Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results. * Female patients who are pregnant or breast feeding * HIV-positive
References
Publications (0)
Data not yet available
No reference posted for this study.