Phase 2
N=20
Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia
Acute Myeloid Leukemia · Myelodysplastic Syndrome · Chronic Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00469014 ↗Enrolled (actual)
20
Serious AEs
22.2%
Results posted
Jan 2021
Primary outcome: Primary: Treatment Related Mortality — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Clofarabine (Drug); Busulfan (Drug); Fludarabine (Drug); Stem Cell Infusion (Other); Thymoglobulin (ATG) (Drug); Filgrastim (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Related Mortality |
0; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- 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.
- 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.
- age /=45% No uncontrolled arrhythmias or symptomatic cardiac disease.
- 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 1L prior to drainage.
- HIV-positive.
- Hepatitis C or HBsAg positive
- 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.
- Active or prior Central Nervous System (CNS) leukemia
- Biphenotypic acute leukemia.
Data sourced from ClinicalTrials.gov (NCT00469014). 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.