Clinical trial · Interventional
SMD_FLAG-IDA_98: FLAG-IDA in Induction Treatment of High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia
FLAG-IDA Chemotherapy Induction Follow by Intensive Chemotherapy Postremission +/- Autologous Hemopoietic Stem Cell Transplantation or Bone Marrow Transplantation in Patients With High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia.
- 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)
Association group of therapeutic specialities authorized in a remission induction treatment(FLAG-IDA: fludarabine, cytarabine, G-CSF (lenograstim) and idarubicin) and an intensive postremission treatment with authorized therapeutic association specialities and with/without Autologous Hemopoietic Stem Cell Transplantation or Bone Marrow Transplantation in Patients With High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia.
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 Myeloblastic Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone marrow transplantation | Procedure | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Idarubicin | Drug | Idarubicin | ALIAS |
| Peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluation of efficacy of study treatment: complete remission rate, remission duration and global survival
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Evaluation of neutropenia and thrombocytopenia duration post-induction chemotherapy
- timeFrame
- 3 months
- measure
- Determinate the percentage of patients that reach the transplantation
- timeFrame
- 3 months
- measure
- Determinate the toxicity of induction regimen and the chemotherapy postremission
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age \< 75 years * Diagnosis of Myelodysplastic Syndrome in order to FAB criteria, excluding patients with chronic myeloid leukemia. * IPI \> 1 (High risk or Intermedia risk-2) and/or IPE equal or \> 3 (High risk o Intermedia risk) or secondary acute myeloid leukemia. * Resolved toxicity for previous treatments received to Myelodysplastic Syndrome . * Myelodysplastic Syndrome de novo. Exclusion Criteria: * Associated neoplasia. * Chronic disease that can limit the patient follow up protocol (cardiovascular disease, active infection uncontrolled, etc.). * Age \< 55 years with related donor HLA compatible. * Use an investigational drug in the 30 previous days. * Previous treatment with chemotherapy agents. * Simultaneous treatment during the study with other drugs not allowed in the protocol. * Bilirubin \> 2 mg/dL and GPT \>2 times the normal value. * Creatinine \> 2 mg/dL. * Hypersensibility to agents used in the protocol. * Secondary MDS to chemo-radiotherapy . * HIV positive. * Chronic myeloblastic leukemia
References
Publications (0)
Data not yet available