Phase 3
Completed N=225
IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
Source: ClinicalTrials.gov NCT00469144 ↗Enrolled (actual)
225
Serious AEs
2.2%
Results posted
Jan 2021
Primary outcomePrimary: Treatment-related Mortality (TRM) — 3; 3; 7; 3 Percentage of Participants — p=0.9
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The goal of this clinical research study is to learn if giving busulfan in a dose based on blood levels, along with a fixed (unchanging) dose of fludarabine, is more effective and causes fewer side effects for AML or myelodysplastic syndrome patients than the standard method of giving a fixed busulfan dose based on body size, along with a fixed dose of fludarabine. The safety of dosing based on blood levels will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-related Mortality (TRM) |
3; 3; 7; 3; 19; 17 | 0.9 |
| PRIMARY 3 Year Progression Free Survival |
42; 56 | — |
Eligibility Criteria
Inclusion Criteria
- Acute myeloid leukemia past first remission, in first or subsequent relapse, in first remission (cytogenetics other than t(8;21, inv 16, t(15;17)) or induction failures. Only myeloid leukemia but not biphenotypic leukemia is allowed on this study.
- Myelodysplastic syndromes with intermediate or high risk International Prognostic Scoring System score
- Patient has not been administered any other systemic chemotherapeutic drug (including Mylotarg) within 21 days prior to trial enrollment (BMT Day -7 or day -9 for the test-dose arm of the study). Hydroxyurea is permitted if indicated to control induction refractory disease, and IT chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed leptomeningeal disease, that has been in remission for at least 3 months prior to enrollment on this study).
- No active infection. Protocol PI will be final arbiter if there is uncertainty regarding whether a previous infection is resolved.
- age 12 weeks.
- Left ventricular ejection fraction >45% No uncontrolled arrhythmias or symptomatic cardiac disease.
- No symptomatic pulmonary disease. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) >/= 50% of expected corrected for hemoglobin. In patients 1L prior to drainage.
- HIV-negative.
- Female patient is not pregnant (negative B-human chorionic gonadotropin (HCG) pregnancy test in all women of child-bearing-potential in accordance with departmental routine).
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
- No prior autologous stem cell transplants
Exclusion Criteria
- None.
Data sourced from ClinicalTrials.gov (NCT00469144). 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.