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

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Treatments: Antilymphocyte Serum; Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Cytarabine; Mycophenolic Acid; Thymoglobulin

Criteria

Patient Inclusion Criteria:

• Patient age 14-60 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, with <5% bone marrow blasts before HSCT

ALL in remission, defined as <5% bone marrow blasts morphologically

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

NHLs (including diffuse large B-cell lymphoma, lymphoblastic lymphoma, Burkitt lymphoma, peripheral T-cell lymphoma, and NK or NK-T cell lymphoma) which are relapsed/refractory OR in CR2 or beyond

• 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

• 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