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

An Open, Multi-center, Randomized Trial Comparing Haploidentical HSCTs From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies

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

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 acute leukemias and MDS who are eligible to haploidentical HSCTs. 2 groups of patients will be enrolled with 116 in each group. The clinical criteria including survival, relapse, transplantation-related mortality will be monitored.

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