Clinical trial · Interventional
A Phase II Study of Maintenance With Azacitidine in MDS Patients
A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy
NCT00446303CI-TRIAL-00006087terminatedPhase 2ClinicalTrials.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)
A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving complete or partial remission (CR or PR) after intensive chemoterapy. The primary objective is response duration (MDS or AML)
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 |
|---|---|---|---|
| Leukemia, Myelocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Reponse duration and cumulative incidence of relapses
- timeFrame
- 1-24 months
Secondary outcomes (2)
- measure
- Toxicity according to WHO
- timeFrame
- 1-24 months
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * MDS with int 2 or high IPSS score eitherRAEB 1 or 2 according to the WHO classification (see appendix 1) or CMML with WBC \< 13 109/l RAEB-T according to the FAB classification (see appendix 1) without t(8 ;21), inv 16 or t(16;16) AML secondary to MDS (sAML) with a confirmed MDS phase of at least 2 months with available bone marrow cytogenetics at diagnosis of AML AND in CR or PR according to IWG criteria (see appendix 3) after one or two courses of predefined intensive chemotherapy (see page 12) with available cytogenetics at evaluation of response Aged 18 years of age or more Written Informed consent Adequate Contraception, if relevant Negative pregnancy test if relevant. Patients not eligible for the azacitidine confirmatory trial (azacitidine " versus " conventional treatment ") or unwilling to participate to it Exclusion Criteria: * AML secondary to myeloproliferative or MDS/MPD WHO subgroups except CMML with WBC\< 13 109/l * Therapy related MDS (after chemo or radiotherapy for a previous neoplasm or immune disorder) * Patients eligible for allogeneic bone marrow transplantation (with a identified donor) * Liver and/or kidney failures prohibiting the use of azacitidine. Creatininemia \> 1.5 normal value ALAT and ASAT \> 3N * Bilirubin \> 2 N, unless due to dyserythropoiesis * Known hypersensitivity to azacitidine or mannitol * Other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor * Uncontrolled infection, * WHO Performance status \> 2 * Life expectancy less than 3 months
References
Publications (0)
Data not yet available
No reference posted for this study.