Clinical trial · Interventional
Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia
Busulfan-Fludarabine-Clofarabine With Allogeneic Stem Cell Transplantation for Advanced Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Advanced, Gleevec Refractory Chronic Myeloid Leukemia. A Randomized Phase II Study.
- 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 goal of this clinical research study is to find the best dose of clofarabine and fludarabine that can be given with busulfan followed by an allogeneic blood stem cell transplant. Researchers will study whether this combination can help to control the disease, and look at the safety of this combination. Researchers also want to find out if combining busulfan with clofarabine alone or combining busulfan with both fludarabine and clofarabine will improve the treatment, compared with the previous standard method using busulfan and fludarabine alone.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Clofarabine | Drug | Clofarabine | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Stem Cell Infusion | Other | — | UNRESOLVED |
| Thymoglobulin (ATG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine
- description
- 4-day Treatment Period Day -6 to Day -2: Busulfan 30 mg/m\^2 intravenous (IV) Daily + Fludarabine 30 mg/m\^2 IV Daily; + Clofarabine 10 mg/m\^2 IV Daily; Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
- interventionNames
- Drug: Clofarabine
- Drug: Busulfan
- Drug: Fludarabine
- Other: Stem Cell Infusion
- Drug: Thymoglobulin (ATG)
- Drug: Filgrastim
- type
- EXPERIMENTAL
- label
- Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine
- description
- 4-day Treatment Period Day -6 to Day -2: Busulfan 20 mg/m\^2 IV + Fludarabine 20 mg/m\^2 IV Daily + Clofarabine 20 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
- interventionNames
- Drug: Clofarabine
- Drug: Busulfan
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis or 1) Acute myeloid leukemia past first remission, in first or subsequent relapse, or induction failures, 2) Myelodysplastic syndromes with intermediate or high risk International Prognostic Scoring System score (IPSS scores) (16), and having failed previous chemotherapy, or 3) Chronic Myeloid Leukemia, Philadelphia-chromosome positive and having failed / being resistant to therapy based on Gleevec or other tyrosine kinase inhibitors. 2. Patient has not been administered intensive systemic chemotherapeutic drugs within 21 days prior to trial enrollment (bone marrow transplant (BMT) Day -9). Gleevec, alternative tyrosine kinase inhibitors, other nonmyelosuppressive agents, low dose cytarabine, hydroxyurea is permitted if indicated to control the leukemia. All tyrosine inhibitor- or other non-myelosuppressive agents have to be terminated at least one week prior to admission for this treatment. 3. No uncontrolled infection. Protocol principal investigator (PI) will be final arbiter if there is uncertainty regarding whether a previous infection is resolved on appropriate antibiotics therapy. 4. age \</= 60 5. A related or unrelated donor who is HLA-matched or mismatched in 1 HLA, A, B, C, DR or DQ locus is acceptable (i.e. at least a 9/10 matched related or unrelated donor, matched with molecular high-resolution technique per current standard for the BMT program). 6. ZUBROD performance status \<2 7. Life expectancy is not severely limited by concomitant illness. 8. Left ventricular ejection fraction \>/=45% No uncontrolled arrhythmias or symptomatic cardiac disease. 9. Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capacity (DLCO) \>/= 50% of expected corrected for hemoglobin. In patients \</= 7 years pulmonary function will be assessed per pediatric BMT routine 10. Serum creatinine \</= 1.5 mg%. 11. Serum glutamic pyruvic transaminase (SGPT) \</= 200 IU/ml, serum bilirubin and alkaline phosphatase within accepted laboratory standard normal limits or considered not clinically significant. No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and perform liver biopsy pror to determining study eligibility. 12. Female patient is not pregnant (negative human chorionic gonadotropin (hCG) pregnancy test in all women of child-bearing-potential in accordance with departmental routine). 13. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent. Exclusion Criteria: 1. Effusion or ascites estimated to be \>1L prior to drainage. 2. HIV-positive. 3. Hepatitis C or HBsAg positive 4. Prior stem cell transplant after a myeloablative conditioning program (such as busulfan-based using a total dose of \>/= 12 mg/kg given by mouth or \>/= 10 mg/kg IV, or a total-body irradiation-based program. 5. Active or prior Central Nervous System (CNS) leukemia 6. Biphenotypic acute leukemia.
References
Publications (1)
- RESULTAndersson BS, Valdez BC, de Lima M, Wang X, Thall PF, Worth LL, Popat U, Madden T, Hosing C, Alousi A, Rondon G, Kebriaei P, Shpall EJ, Jones RB, Champlin RE. Clofarabine +/- fludarabine with once daily i.v. busulfan as pretransplant conditioning therapy for advanced myeloid leukemia and MDS. Biol Blood Marrow Transplant. 2011 Jun;17(6):893-900. doi: 10.1016/j.bbmt.2010.09.022. Epub 2010 Oct 11. PMID 20946966