RecruitingPhase 3NCT04547049

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

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

176 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Conditions

Leukemia

Summary

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

Eligibility

Min Age: 13 YearsMax Age: 78 Years

Inclusion Criteria22

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
The donor and recipient must be HLA haploidentical
Meets institutional selection criteria and medically fit to donate
Lack of recipient anti-donor HLA antibody

Exclusion Criteria13

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
The donor and recipient are HLA identical
Has not donated blood products to recipient

Interventions

DRUGCytarabine

4 mg/m2/day administered IV day -10 through -9.

DRUGBusulfan

3.2 mg/kg/day administered IV day -8 through -6.

DRUGCyclophosphamide

1.8 g/m2/day administered IV day -5 through -4.

DRUGMe-CCNU

250mg/m2 once administered orally on day -3.

DRUGRabbit antithymocyte globulin

Between 6mg/kg total dose administered IV day -5 through -2 AND 7.5mg/kg total dose administered IV day -5 through -2.

PROCEDUREAllogeneic HSCT

Day 0

DRUGCyclosporin A

2.5 mg/kg/day administered intravenously from day -7, target: 200-300ng/mL. Usually tapered during the second month, and ended in complete withdrawal during the ninth month after transplantation.

DRUGMycophenolate Mofetil

500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.

DRUGMTX

15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.