NCT04838704

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The is a prospective, randomized two-arm, and multicenter study. To compare the efficacy and safety of low-dose ruxolitinib combined 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.

Conditions

• Graft Versus Host Disease

Interventions

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

Timeline

• Start date: 2021-04-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-04-09
• Last updated: 2025-06-04

Locations

1 site across 1 country: China