Clinical trial · Observational
Pharmacoeconomics in the Application of 5-azacitidine in the Treatment of Myelodysplastic Syndromes and Acute Myeloid Leukemia
NCT04296214CI-TRIAL-00052630withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor recruitment
Summary
Brief summary (as posted)
The investigators want to compare the global response rate of patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) after six months of treatment with 5-azacitidine on two different doses. First group of 50 mg/m2 for 10 days each 28 days versus 75 mg/m2 for 7 days on 28 days cycles.
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 Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-azacitidine | Drug | Azacitidine | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- A
- description
- Azacitidine 50 mg/m2 for 10 days each 28 days
- interventionNames
- Drug: 5-azacitidine
- label
- B
- description
- Azacitidine 75 mg/m2 for 7 days each 28 days
- interventionNames
- Drug: 5-azacitidine
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 6 months
- description
- Global response rate by International Criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Confirmed diagnosis of MDS that require treatment with 5-aza characterized by: i) RAEB-1 defined as the presence of 5%-9% of myeloblasts in bone marrow; ii) RAEB-2 defined as the presence of 10%-19% of myeloblasts in bone marrow or 5%-19% blasts in peripheral blood; iii) IPSS-R very high, high or intermediate * Confirmed AML with blasts ≥ 20% in bone marrow or peripheral blood and that its not candidate to receive intense chemotherapy at consideration of the physician. * Performance status of 0, 1 o 2 by the Eastern Cooperative Oncology Group (ECOG). * Availability to sign an informed consent Exclusion Criteria: * Previous treatment for MDS or AML with chemotherapy or another antineoplastics including hypomethylating agents. * Acute promyelocytic leukemia
References
Publications (0)
Data not yet available
No reference posted for this study.