Clinical trial · Interventional
A Study Comparing Haploidentical Hematopoietic Stem Cell Transplantations (HSCTs) From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies
An Open, Multi-center, Randomized Trial Comparing Haploidentical HSCTs From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies
NCT04547049CI-TRIAL-00107713active not recruitingPhase 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)
An open, multi-center, randomized trial comparing haploidentical HSCTs from young non-first-degree and older first-degree donors in hematological malignancies
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic HSCT | Procedure | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cyclosporin A | Drug | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Me-CCNU | Drug | — | UNRESOLVED |
| MTX | Drug | Methotrexate | ALIAS |
| Mycophenolate Mofetil | Drug | — | UNRESOLVED |
| Rabbit antithymocyte globulin | Drug |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Non-first-degree donor
- description
- Each patient receive graft from a non-first degree donor aged ≤40 Conditoning regimens are decided by each center accoding to disease risk, patient age \& status, and cormobidity index.The centers are required to use the same principle when treating NFD and FD patients. The used protocol in the current study included: For MAC: use BU-CY-based (described in detail) For RIC: use BUFlu: Drug: Fludarabine 30 mg/m²/kg, administered IV d-10 through d-5. Drug: Busulfan, 3.2 mg/kg/day administered IV day -6 (BU2) or -7 through -5 (BU3). Other conditioning regimen may include: TBF, FluMel, FBM, Cy-TBI, Flu-TBI.
- interventionNames
- Drug: Cytarabine
- Drug: Busulfan
- Drug: Cyclophosphamide
- Drug: Me-CCNU
- Drug: Rabbit antithymocyte globulin
- Procedure: Allogeneic HSCT
- Drug: Cyclosporin A
- Drug: Mycophenolate Mofetil
- Drug: MTX
- type
- ACTIVE_COMPARATOR
- label
- First-degree donor
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Patient Inclusion Criteria: * Patient age 13-78 years * Absence of a suitable HLA identical related or unrelated hematopoietic stem cell donor * Absence of a suitable partially HLA-mismatched (haploidentical), first-degree related donor aged between 18 and 50 * Presence of both HLA haploidentical young non-first-degree (age ≤ 40) and older first-degree (age \>50) donors Eligible diagnoses: AML（excluding APL） with at least one of the following: * median- or high- risk according to the WHO prognostic stratification system * failure to achieve CR after 2 cycles of induction chemotherapy * AML arising from MDS or a myeloproliferative disorder, or secondary AML * patients in CR2 or beyond Mixed-phenotype acute leukemia (MPAL) in morphological remission Acute lymphoblastic leukemia (T or B) in morphological remission MDS with at least one of the following: * IPSS score of INT-2 or greater * IPSS score of INT-1 with life-threatening cytopenias, including those generally requiring greater than weekly transfusions * A first allo-HCT * Adequate end-organ function * ECOG performance status \< 2 * No other contraindications for HSCT * Signature of the informed consent Patient Exclusion Criteria * Availability of suitable HLA identical related or unrelated hematopoietic stem cell donors * Availability of suitable partially HLA-mismatched (haploidentical), first-degree related donor aged between 18 and 50 * Not the first allo-HCT * Presence of uncontrolled bacterial, viral, or fungal infection * Patients with severe heart, lung, liver and kidney insufficiency * HIV-positive patients * Women of childbearing potential who are pregnant (β-HCG+) or breast feeding * Patients with a psychiatric history * ECOG performance status ≥ 2 * Patients with malignancies other than the primary disease * Refusal to sign the informed consent Donor Inclusion Criteria: * The donor and recipient must be HLA haploidentical * Meets institutional selection criteria and medically fit to donate * Lack of recipient anti-donor HLA antibody Donor Exclusion Criteria: * The donor and recipient are HLA identical * Has not donated blood products to recipient
References
Publications (0)
Data not yet available
No reference posted for this study.