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

Overview

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

Description

This is an open, multi-center, randomized trial comparing the clinical outcomes of haploidentical HSCTs from young non-first-degree and older first-degree donors in hematological malignancies. This study is indicated for patients with hematological malignancies including ALL, AML, MDS and NHL who are eligible to haploidentical HSCTs. 2 groups of patients will be enrolled with 80 in each group. The clinical criteria including survival, relapse, transplantation-related mortality will be monitored.

Eligibility

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