A Study Comparing Haploidentical Hematopoietic Stem Cell Transplantations (HSCTs) From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies
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
No
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
Status
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
More First Affiliated Hospital of Zhejiang University trials in China
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.
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