Ruxolitinib With Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation

Sponsor
Zhejiang University
Study ID
NCT04838704
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib+Calcineurin inhibitor+Methotrexate — DRUG
    low-dose ruxolitinib combine with calcineurin inhibitor and short course of methotrexate.
  • Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil — DRUG
    calcineurin inhibitor and short course of methotrexate and mycophenolate mofetil

Study Details

Low Dose Ruxolitinib with Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor plus Methotrexate and Mycophenolate mofetil as Graft Versus Host Disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.

Key Dates

Start date
Apr 1, 2021
Status verified
May 2025
Primary completion
Dec 1, 2024
Completion
Dec 1, 2024

Study Design

Enrollment
215 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: RUX group
  • Active Comparator: Control group

Primary Outcome Measure

100-day cumulative II-IV aGVHD incidence after HSCT [ Time Frame: From the date of transplantation to the first occurrence of grade II-IV acute GVHD, assessed up to 100 days. ]

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