Phase 2
Completed N=116
High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML
Source: ClinicalTrials.gov NCT00774046 ↗Enrolled (actual)
116
Serious AEs
21.9%
Results posted
Jun 2013
Primary outcomePrimary: Response to Induction Chemotherapy (CR or PR) — 81.2 percentage of participants
Summary
The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response to Induction Chemotherapy (CR or PR) |
81.2 | — |
| PRIMARY Overall Survival |
399 | — |
| PRIMARY Relapse-free Survival |
415 | — |
| SECONDARY Feasibility of Stem Cell Collection |
70 | — |
| SECONDARY Numbers of Stem Cells Collected |
4.50 | — |
| SECONDARY Overall Survival in Patients Undergoing Autologous Stem Cell Transplant |
294 | — |
| SECONDARY Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant |
367 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have received cytotoxic chemotherapy, radiation,or a drug known to affect the properties of DNA or cell growth for some condition other than acute myeloid leukemia prior to diagnosis.
- Patients must have t-MDS/t-AML
- To be eligible for allogeneic transplantation, patients must have a suitable donor who is HLA compatible.
- Patients must be over the age of 10.
- Patients must be reviewed and discussed at the Leukemia and Transplant Conferences of the Section of Hematology/Oncology.
Exclusion Criteria
- Patients must not have any other serious medical condition(e.g.uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection)
- Psychiatric condition which would prevent compliance or possibly be worsened by treatment
Data sourced from ClinicalTrials.gov (NCT00774046). 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.