Clinical trial · Interventional
Azacitidine Compared to Conventional Chemotherapy as Consolidation of Elderly Patients With AML
Azacitidine Compared to Conventional Chemotherapy in Consolidation of Elderly Patients (65 Years or Older) With AML in First Complete Remission
NCT01794169CI-TRIAL-00019169terminatedPhase 2ClinicalTrials.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 purpose of this study is to determine whether Azacitidine consolidation is superior to standard DA consolidation treatment of acute myeloid leukemia in first complete remission in elderly patients.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| DA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Azacitidine
- description
- Azacitidine 75mg/m2/d subcutaneously once daily for 5 days given every 5:th week for 8 cycles.
- interventionNames
- Drug: Azacitidine
- type
- ACTIVE_COMPARATOR
- label
- DA
- description
- Two courses of DA in accordance with the Swedish National treatment program (reduced doses): In case one induction course was given: First consolidation course: daunorubicin 45 mg/m2 x 1 (iv infusion) day 1-3 and cytarabine 1000 mg/m2 x 2 (iv infusion) day 1-4. Second consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5. In case two induction courses were given: First consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5. Second consolidation course: cytarabine 200mg x 2 (fixed dose sc injection) day 1-5.
- interventionNames
- Drug: DA
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects \>65 years of age at the time of signing the informed consent form 2. A confirmed diagnosis of AML according to the 2008 WHO classification * This includes: Bone marrow aspirate with a good clot or biopsy for morphology, flow cytometry, cytogenetic analysis, and in case of normal cytogenetics, molecular genetic analyses including FLT3-ITD, NPM-1 and CEBP A * Bio-banking of leukemic cells at diagnosis performed (according to guidelines of the Swedish National AML biobank). 3. A documented CR or CRp achieved after one or two induction courses. Exclusion Criteria: 1. Subjects who are not considered to be candidates to complete the consolidation therapy due to medical or psychological reasons. 2. Subjects who have taken any investigational drugs or participated in an interventional clinical trial within 30 days prior to screening. 3. Patients with acute promyelocytic leukemia 4. Patients with t(8;21) or inv(16) 5. CNS leukemia 6. Patients with a previous diagnosis of MDS, i.e. AML preceded by a diagnosed MDS 7. Subjects who are candidates for allogeneic stem cell transplantation (SCT) 8. Another cancer diagnosis with a life expectancy of less than two years
References
Publications (0)
Data not yet available
No reference posted for this study.