Clinical trial · Interventional
Haplo HCT vs Haplo-cord HCT for Patients With AML
An Open-label, Multicenter, Randomized, Phase 3 Trial to Assess the Efficacy and Safety of Coinfusion With Unrelated Cord Blood Unit for Patients With Acute Myeloid Leukemia Undergoing Haploidentical Hematopoietic Cell Transplantation
- 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 who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.
Conditions
Conditions (4)
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 |
| Cord Blood Unit | — | UNRESOLVED | — |
| Haplo-identical Donor | — | UNRESOLVED | — |
| Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| haplo-cord HCT | Procedure | — | UNRESOLVED |
| haplo-HCT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Haplo-HCT
- description
- people enrolled in this arm will receive a typical haploidentical donor HCT
- interventionNames
- Procedure: haplo-HCT
- type
- EXPERIMENTAL
- label
- Haplo-cord HCT
- description
- people enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical donor HCT
- interventionNames
- Procedure: haplo-cord HCT
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 3 year after randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 to 60 years old; 2. Patients with AML; 3. With available minimal residual disease (MRD) parameters assessed by flow cytometry (FCM) and/or quantitative real-time PCR (qPCR) 4. Having no available HLA-matched donor, and willing to undergo haplo-HCT and having a suitable haploidentical donor 5. With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 6. Signing informed consent form, having the ability to comply with study and follow-up procedures Exclusion Criteria: 1. Acute promyelocytic leukaemia (AML subtype M3) 2. With other malignances 3. Failing to acquire a suitable UCB unit 4. With previous history of autologous haematopoietic cell transplantation (auto-HCT), allogeneic haematopoietic cell transplantation (allo-HCT) or chimaeric antigen receptor T-cell therapy 5. With uncontrolled infection intolerant to haplo-HCT 6. With severe organ dysfunction * Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy) * Respiratory failure (PaO2≤60 mmHg) * Hepatic abnormalities (total bilirubin≥2×upper limit of normal \[ULN\], alanine aminotransferase or aspartate aminotransferase≥2×ULN) * Renal dysfunction (creatinine≥2 mg/dL creatinine clearance rate \< 30 mL/min) 7. In pregnancy or lactation period 8. With any conditions not suitable for the trial (investigators' decision)
References
Publications (1)
- DERIVEDZhou B, Chen J, Liu T, Ye Y, Zhang Y, Ding Y, Liu H, Zhu M, Ma X, Li X, Zhao L, Lin Z, Huang H, Xu Y, Wu D. Haploidentical hematopoietic cell transplantation with or without an unrelated cord blood unit for adult acute myeloid leukemia: a multicenter, randomized, open-label, phase 3 trial. Signal Transduct Target Ther. 2024 May 6;9(1):108. doi: 10.1038/s41392-024-01820-5. PMID 38705885