Clinical trial · Interventional
Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia
Efficacy and Safety of Decitabine in Combination With Low-dose Cytarabine as Inductive Treatment in Newly Diagnosed Elderly Patients With Acute Myeloid Leukemia
NCT02985372CI-TRIAL-00025066unknownPhase 3ClinicalTrials.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)
This prospective multicenter clinical study was designed to assess the efficacy and safety of decitabine in combination with low-dose cytarabine induction treatment for elderly patients with newly diagnosed acute myeloid leukemia (AML).
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, Adult | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Acute myeloid leukemia
- description
- All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
- interventionNames
- Drug: Decitabine
- Drug: Cytarabine
Primary outcomes (2)
- measure
- Overall response rate
- timeFrame
- three years
- measure
- complete remission rate
- timeFrame
- three years
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with previously untreated non-M3 AML (diagnosed by the WHO2016 criteria). 2. Age: ≥ 60 and ≤ 75 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 2ULN. 5. Without central nervous system symptoms. 6. Willing to accept the follow-up. 7. Normal heart function(EF\>50%). The subjects volunteer to sign the informed consent. Exclusion Criteria: 1. With severe cardiac, renal or hepatic insufficiency. 2. With other cancers requiring treatment. 3. With other hematological diseases(e.g. Hemophilia, myelofibrosis, etc.). 4. With severe infection or metabolic disease(including tuberculosis and pulmonary aspergillosis). 5. Brain disorders or severe mental diseases which could limit compliance with study requirements. 6. Major operation within 3 weeks. 7. With HIV infection or AIDS-associated diseases. 8. Any drug abuse, medical, mental or social situations which would affect the results. 9. Hypersensitivity to cytarabine (not including drug fever or exanthema) or decitabine.
References
Publications (0)
Data not yet available
No reference posted for this study.