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