Clinical trial · Interventional
HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk
Compare the Safety and Effective of HLA-mismatched Microtransplantation With HLA-matched Nonmyeloablative Transplantation for Acute Myeloid Leukemia in Intermediate-risk
NCT02461121CI-TRIAL-00018155completedPhase 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 with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.
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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-lymphocyte globulin | Drug | — | UNRESOLVED |
| Ara-C | Drug | Cytarabine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine A | Drug | — | UNRESOLVED |
| fludarabine | Drug | Fludarabine | ALIAS |
| HLA matched stem cell | Genetic | — | UNRESOLVED |
| HLA mismatched stem cell | Genetic | — | UNRESOLVED |
| Mycophenolate mofetil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MST（microtransplantation）
- description
- The microtransplantation conditioning regimen included high-dose Ara-C chemotherapy (2.0 to 2.5 g/m2 per 12 hours intravenously on days -4 to -2) followed by an infusion of HLA mismatched stem cell 24 hours (day 0) after the completion of cytarabine.
- interventionNames
- Genetic: HLA mismatched stem cell
- Drug: Ara-C
- type
- ACTIVE_COMPARATOR
- label
- NST（nonmyeloablative transplantation）
- description
- The NST（nonmyeloablative transplantation）conditioning regimen consisted of 30 mg/m2/d fludarabine for days -6 to -2, 1.5-2 mg/kg/d anti-lymphocyte globulin for days -5 to -2, 40 mg/kg/d cyclophosphamide for days -4 and -2 and 2.0-3.0 g/m2/d cytarabine for days -6 to -4，followed by an infusion of HLA matched stem cell after the completion of regimen. The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
- interventionNames
- Genetic: HLA matched stem cell
- Drug: cyclosporine A
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have elderly (9-59 ages) AML pathologically confirmed per WHO guidelines. * Patients WITH intermediate-risk AML-CR1 * 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 * 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.