Clinical trial · Interventional
5-azacytidine Valproic Acid and ATRA in AML and High Risk MDS
Multi Centers, Open-trial Phase II Study Evaluating 5-azacytidine (Vidaza®) + Valproic Acid (Depakine ®) Before Administration of Retinoic Acid (Vesanoid®) in Patients With Acute Myelogenous Leukemia and High Risk Myelodysplasia.
- 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)
MULTICENTERS. Uncontrolled and open phase II study. Evaluation of the effectiveness of a treatment associating 5 Azacytidine,Valproic acid ,Retinoic Acid at subjects-reached of syndromes myelodysplasia and acute MYELOID leukaemia Hematological response at 6 months Uncontrolled prospective cohort.
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 Myelogenous Leukaemia (AML) | Acute Myeloid Leukemia | ALIAS | 0.85 |
| Myelodysplastic Syndrome (MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5 azacytidine - VALPROIC acid- Retinoic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 5-azacytidine VALPROIC acid and ATRA
- interventionNames
- Drug: 5 azacytidine - VALPROIC acid- Retinoic acid
Primary outcomes (1)
- measure
- Hematological response at 6 months
- timeFrame
- at 6 months
Secondary outcomes (3)
- measure
- Evaluating Red Blood cells and Platelets transfusion
- timeFrame
- during the study
- measure
- Evaluating Days of hospitalisation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 years * high Risk Acute Myelogenous Leukemia (FAB-M3 excluded), including : * AML in first relapse in patients with secondary AML(after MDS and CMML) * AML in first relapse in patients with a CR duration \< 12 months * Second Relapse or \> 2 * de novo AML without previous treatment in elderly patients (FAB-M3 excluded) , if : * 70 years * with de novo AML or secondary AML (Transformation of myelodysplasia) * Unfit for Intensive chemotherapy * High risk myelodysplasia, including : * RAEB or t-RAEB (FAB) * With IPSS score Intermediate-2 or High risk (Greenberg, 1997) * non eligible for allogeneic HSC transplantation * Women of childbearing potential (WOBP) must be using an adequate method of contraception * Men with WOBP have to use an acceptable method to avoid pregnancy * Signed Written informed consent Exclusion Criteria: * APL(FAB) * Clinical CNS involvement * Uncontrolled infectious disease * Adequate hepatic function defined as total bilirubin \< 3 times ULN ALAT and ASAT \< 2.5 times ULN * Adequate renal function (serum creatinine \< 1.5x ULN anc Creatinine clearance \< 25ml/min) * Included in an other clinical trial * Previous treatment with 5-aza \&/or Valproic acid \&/or retinoic acid * Positive pregnancy test * Women who are breastfeeding
References
Publications (0)
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