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

NCT04547049 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2026-04-09

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Yi Luo, MD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2026-04-01
Completion
2026-04-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04547049 on ClinicalTrials.gov