Clinical trial · Interventional
Efficacy and Safety of Chidamide in CBF Leukemia
NCT03031262CI-TRIAL-00090375active not recruitingPhase 1 / Phase 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)
In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML) patients who have reached CR are randomised into two groups and receive high-dose cytarabine (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is evaluated.
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 |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- High Dose of Cytarabine
- description
- CBF Patients who reach CR after reduction therapy receive high dose of cytarabine.
- interventionNames
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- HDAC + Chidamide
- description
- CBF Patients who reach CR after reduction therapy receive high dose of cytarabine plus chidamide.
- interventionNames
- Drug: Cytarabine
- Drug: Chidamide
Primary outcomes (1)
- measure
- Relapse-Free Survival Rate (RFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age of 14 to 55 years old; 2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes) and with AML1-ETO or CBF-MYH11 mutation. 3. Reached CR after induction regimen. 4. ECOG score of ≤ 2; 5. Patients with eligible laboratory examination including liver,renal and heart function. 6. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent. Exclusion Criteria: 1. Secondary leukemia. 2. Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor. 3. Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included. 4. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients; 5. With BCR-ABL fusion gene; 6. Pregnant or lactating women; 7. With ineligible renal or liver function; 8. With active cardiovascular disease; 9. Severe infection disease including uncured tuberculosis pulmonary aspergillosis; 10. AIDS; 11. Patients had central nervous system involvement when they were diagnosed as AML. 12. Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research. 13. Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results. 14. Patients with other factors which were considered unsuitable to participate in the study by the investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.