NCT04547049

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 13 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 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.

Conditions

• Leukemia
• MDS

Interventions

Type	Name	Description
DRUG	Cytarabine	4 mg/m2/day administered IV day -10 through -9.
DRUG	Busulfan	3.2 mg/kg/day administered IV day -8 through -6.
DRUG	Cyclophosphamide	1.8 g/m2/day administered IV day -5 through -4.
DRUG	Me-CCNU	250mg/m2 once administered orally on day -3.
DRUG	Rabbit 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.
PROCEDURE	Allogeneic HSCT	Day 0
DRUG	Cyclosporin 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.
DRUG	Mycophenolate Mofetil	500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.
DRUG	MTX	15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.

Timeline

• Start date: 2020-09-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2020-09-14
• Last updated: 2026-04-09

Locations

8 sites across 1 country: China