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

Summary

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

Eligibility

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 ≥ 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

Conditions2

Interventions8

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