Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT06973668
Brief Summary:
The goal of this clinical research study is to compare the effects of these drug combinations (cyclophosphamide, sirolimus, and MMF vs cyclophosphamide, sirolimus, and ruxolitinib) on the prevention of GVHD after a stem cell transplant.
Detailed Description:
Primary Objective:
To compare Grade 2-4 acute graft versus host disease-free survival (GFS) between the MMF and Ruxolitinib arms
Secondary Objectives:
To compare the following between treatment arms:
1. Grade 3-5 adverse event of this regimen as per CTCAE v5.0 criteria.
2. Graft versus host disease-free, relapse-free survival (GRFS)
3. Time to neutrophil and platelet engraftment
4. Incidence of acute and chronic GVHD
5. Relapse incidence
6. Non relapse mortality
7. Overall survival
8. Progression-free survival
9. Chimerism
10. Immunosuppression cessation time
11. Rate of graft failure
Exploratory Objective:
To conduct mechanistic studies to compare immune recovery between arms and correlate these with disease control and GVHD prophylaxis.
Study:
NCT06973668
Study Brief:
Protocol Section:
NCT06973668