A Study Comparing Haploidentical Hematopoietic Stem Cell Transplantations (HSCTs) From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies

NCT04547049 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Zhejiang University

Phase

Phase 3

Started

2020-09-01

Last updated

2026-04-09

Condition(s) studied

LeukemiaMDS

Investigational drug(s) / intervention(s)

Cytarabine →Busulfan →Cyclophosphamide →Me-CCNURabbit antithymocyte globulinAllogeneic HSCTCyclosporin A →Mycophenolate Mofetil →MTX

Cytarabine: 4 mg/m2/day administered IV day -10 through -9.

Busulfan: 3.2 mg/kg/day administered IV day -8 through -6.

Cyclophosphamide: 1.8 g/m2/day administered IV day -5 through -4.

Me-CCNU: 250mg/m2 once administered orally on day -3.

Rabbit antithymocyte globulin: Between 6mg/kg total dose administered IV day -5 through -2 AND 7.5mg/kg total dose administered IV day -5 through -2.

Allogeneic HSCT: Day 0

Cyclosporin A: 2.5 mg/kg/day administered intravenously from day -7, target: 200-300ng/mL. Usually tapered during the second month, and ended in complete withdrawal during the ninth month after transplantation.

Mycophenolate Mofetil: 500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.

MTX: 15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.

Study summary

An open, multi-center, randomized trial comparing haploidentical HSCTs from young non-first-degree and older first-degree donors in hematological malignancies

Eligibility

Sex

ALL

Min age

13 Years

Max age

78 Years

Healthy volunteers

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

Primary outcome measure(s)

Overall survival (OS) — 2 years
All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression.

Trial sites (8)

Facility	City	Region
Xiangya Hospital Central South University	Changsha	China
Xinqiao Hospital, State Key Laboratory of Trauma and Chemical Poisoning, Army Medical University	Chongqing	China
The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	China
Zhejiang Provincial People's Hospital	Hangzhou	China
The First Affiliated Hospital of Nanjing Medical University	Nanjing	China
The Affiliated People's Hospital of Ningbo University	Ningbo	China
The First Affiliated Hospital of Ningbo University	Ningbo	China
The First Affiliated Hospital of Soochow University	Suzhou	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04547049 on ClinicalTrials.gov ↗ ← All trials in China