Comparing stem cell transplants from different donor types for leukemia treatment
An Open, Multi-center, Randomized Trial Comparing Haploidentical HSCTs From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies
This study is testing whether stem cell transplants from younger non-family donors work better than those from older family donors for people with leukemia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 13 Years to 78 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Changsha and 7 other locations) |
| Trial ID | NCT04547049 on ClinicalTrials.gov |
What this trial studies
This open, multi-center, randomized trial aims to compare the clinical outcomes of haploidentical hematopoietic stem cell transplantations (HSCTs) from young non-first-degree donors and older first-degree donors in patients with hematological malignancies, including leukemia. The study will enroll 176 patients, divided into two groups of 88, and will monitor key clinical criteria such as survival rates, relapse occurrences, and transplantation-related mortality. Eligible patients are those aged 13-78 who lack suitable HLA identical or partially mismatched donors and have specific types of leukemia or myelodysplastic syndromes (MDS). The trial will utilize various chemotherapy agents as part of the treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are patients aged 13-78 with hematological malignancies who do not have suitable HLA identical or haploidentical first-degree donors.
Not a fit: Patients with suitable HLA identical donors or those who do not meet the specific eligibility criteria for the trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve transplant outcomes for patients with hematological malignancies by identifying the most effective donor type.
How similar studies have performed: Other studies have explored haploidentical HSCTs, but this specific comparison of donor types is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≥ 3 * 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
Where this trial is running
Changsha and 7 other locations
- Xiangya Hospital Central South University — Changsha, China (Recruiting)
- Xinqiao Hospital, State Key Laboratory of Trauma and Chemical Poisoning, Army Medical University — Chongqing, China (Recruiting)
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, China (Recruiting)
- Zhejiang Provincial People's Hospital — Hangzhou, China (Recruiting)
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, China (Recruiting)
- The Affiliated People's Hospital of Ningbo University — Ningbo, China (Recruiting)
- The First Affiliated Hospital of Ningbo University — Ningbo, China (Recruiting)
- The First Affiliated Hospital of Soochow University — Soochow, China (Recruiting)
Study contacts
- Principal investigator: Yi Luo, MD — First Affiliated Hospital of Zhejiang University
- Study coordinator: Yi Luo, MD
- Email: luoyijr@zju.edu.com
- Phone: 86-13666609126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.