Clinical trial · Interventional
Decitabine Combined With Unrelated Cord Blood Transplantation for Elderly Patients With AML
Multicenter, One-arm, Phase II Clinical Study of Decitabine Combined With Unrelated Cord Blood Transplantation for the Treatment of Acute Myeloid Leukemia (AML) in the Elderly
- 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)
Acute myeloid leukemia (AML) is a clonal disease caused by genetic mutations in Hematopoietic stem progenitor cells. Unfortunately, advanced age (\>60 years old) is considered to be one of the most important adverse prognostic factors for AML, and older patients are unable to tolerate high-dose chemotherapy, due to various complications and organ dysfunction. Based on the results of the previous research, we will carry out the pretreatment regimen of decitabine + cytarabine in elderly patients with AML who have achieved disease treatment through induction therapy, and continue the transplantation program of unrelated-blood cord blood. By assessing the patient's DFS,OS,RFS and safety to determine whether the regimen is suitable for the consolidation treatment of elderly acute myeloid leukemia, further clarify the efficacy of this regimen compared with traditional consolidation therapy, and initially confirm the effect of combined with unrelated cord blood transplantation in the treatment of acute myeloid leukemia.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Unrelated cord blood | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DAC combined with unrelated cord blood transplantation
- description
- Decitabine (DAC) 15mg/m2/d, d-7 to d-3;Ara-C 1000g/m2/q12h, d-2 to d-1.Single unrelated cord blood (TNC\>1.5\*107/kg), d0.
- interventionNames
- Biological: Unrelated cord blood
Primary outcomes (1)
- measure
- Disease free survival (DFS)
- timeFrame
- Three years
Secondary outcomes (3)
- measure
- Overall Survival (OS)
- timeFrame
- Three years
- description
- The time from enrollment to death for any reason
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. AML patients diagnosed by bone marrow morphology and Immunology; 2. Exclusion of APL by Bone marrow morphology or molecular level; 3. A patient who has obtained bone marrow cytology remission after inductive treatment; 4. Aged from 60 to 75 years; 5. Liver and kidney function: blood bilirubin ≤ 35μmol / L, AST or/ALT \<2 times the upper limit of normal (ULN), serum creatinine;≤ 150μmol / L; 6. The function of Heart is normal; 7. Physical condition score 0-2 (ECOG score); 8. Get informed consent signed by patient or family member. Exclusion Criteria: 1. APL patients, treatment-related AML; 2. Retreatment of patients; 3. Allergies to any of the drugs involved in the protocol; 4. There are obvious contraindications to chemotherapy drugs; 5. Liver and kidney function is obviously abnormal, exceeding the inclusion criteria; 6. Serious heart disease, including myocardial infarction, cardiac insufficiency; 7. Suffering from other organ malignant tumors at the same time ; 8. Active period of tuberculosis patients and HIV-positive patients; 9. Suffering from other blood system diseases at the same time; 10. Pregnancy or breastfeeding; 11. Cannot understand or follow the research plan; 12. A history of intolerance or allergies to similar drugs; 13. Patients under 60 years of age or over 75 years of age; 14. Participate in other clinical researchers at the same time; 15. There are other situations that hinder the conduct of the study.
References
Publications (0)
Data not yet available