NCT04547049Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
An open, multi-center, randomized trial comparing haploidentical HSCTs from young non-first-degree and older first-degree donors in hematological malignancies
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 7 Sept 2020
- Start date
- 1 Sept 2020
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Diseases
- Childhood cancers
- NCT number
- NCT04547049
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 232
- From 1 Sept 2020 to the primary completion date, 1 Apr 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 13 years to 78 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Xinqiao Hospital, State Key Laboratory of Trauma and Chemical Poisoning, Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The First Affiliated Hospital, College of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The First Affiliated Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| The Affiliated People's Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.