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

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of stem cell transplant donors for patients with blood cancers who do not have a fully matched donor available: a younger, non-first-degree relative (like a cousin, aged 40 or under) versus an older, first-degree relative (like a parent or sibling, aged over 50). **You may be eligible if...** - You are between 13 and 78 years old - You have a blood cancer such as AML, mixed-phenotype leukemia, ALL, MDS, or MPN, among others - You do not have a fully matched related or unrelated donor available - You have no suitable first-degree donor aged 18–50 - Both a young non-first-degree donor (≤40) and an older first-degree donor (>50) are available for you **You may NOT be eligible if...** - A fully matched (HLA-identical) related or unrelated donor is available - You have a suitable partially matched first-degree donor between ages 18 and 50 - Your cancer is in an uncontrolled state that makes transplant too risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.