Clinical trial · Interventional
High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML
High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia
NCT00774046CI-TRIAL-00013716completedPhase 2Results postedClinicalTrials.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 the effectiveness of a particular combination of drugs used to treat cancer.
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ara-C | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction chemotherapy followed by stem cell transplant
- description
- Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
- interventionNames
- Drug: Ara-C
- Drug: Mitoxantrone
- Drug: Etoposide
Primary outcomes (3)
- measure
- Response to Induction Chemotherapy (CR or PR)
- timeFrame
- Day 28-40
- description
- Complete remission (CR): \<5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): \>5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.