Clinical trial · Interventional
Safety and Efficacy Study of Microtransplantation to Treat Elderly Acute Myeloid Leukemia
Phase III Clinical Trial of Microtransplantation to Treat Elderly Acute Myeloid Leukemia
NCT02171117CI-TRIAL-00022984IMCG-EAMLunknownPhase 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)
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are randomly assigned to standard induction and consolidation chemotherapy with microtransplantation （MST-group）or without (CT-group).Compare the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate of the two groups.
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 |
|---|---|---|---|
| HLA-mismatched donor peripheral stem cell infusion | Biological | — | UNRESOLVED |
| microtransplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- CT-group
- description
- standard induction and consolidation chemotherapy only, without microtransplantation
- type
- EXPERIMENTAL
- label
- MST-group
- description
- standard induction and consolidation chemotherapy with microtransplantation
- interventionNames
- Procedure: microtransplantation
- Biological: HLA-mismatched donor peripheral stem cell infusion
Primary outcomes (1)
- measure
- the remission rate
- timeFrame
- 2 months
- description
- ①bone marrow: blasts \<5% (with a count of at least 200 Nucleated cells).②Hemogram: absolute neutrophil count of more than 1.0×109/L，platelets of \>100×109/L. ③Clinical: Without the signs and symptoms caused by leukemia infiltration d , and independent of transfusion;
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have elderly (60-85 ages) AML pathologically confirmed per WHO guidelines. * Patients have not been treated before. * Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2. * Patients must have a HLA mismatched donor who should be able to provide informed consent. * All genders and races are eligible. * ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min * By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range. * Donors must be able to safely undergo leukapheresis. Exclusion Criteria: * received operation 4 weeks before randomization * acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase; * active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol * occurred stroke or intracranial hemorrhage within 6 months before randomization. * Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant. * There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA). * Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection * Any situation processed by the PI that will be damaged to the patients safety. * Patients and / or authorized family member refuse to sign the consent. * attend other clinical researchers in 3 months. * Donors exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff.
References
Publications (0)
Data not yet available
No reference posted for this study.