Ruxolitinib Treatment for Primary and Secondary Myelofibrosis Before and After Stem Cell Transplant
This phase 2 study aims to evaluate the impact of Ruxolitinib treatment on reducing the incidence of severe graft versus host disease in patients with primary and secondary myelofibrosis, before and after stem cell transplant.
Allogeneic Hematopoietic Stem Cell Transplantation
+ Busulfan
+ Cyclophosphamide
Bone Marrow Diseases+2
+ Hematologic Diseases
+ Hemic and Lymphatic Diseases
Treatment Study
Summary
Study start date: December 18, 2020
Actual date on which the first participant was enrolled.This clinical trial aims to explore the effectiveness of a drug called ruxolitinib for patients diagnosed with primary and secondary myelofibrosis, a condition where the bone marrow is replaced by scar tissue. The study focuses on patients who are set to undergo a hematopoietic stem cell transplantation, a procedure that can help restore the body's ability to produce healthy blood cells. The importance of this study lies in its potential to improve the transplantation process and reduce the risk of complications, ultimately enhancing the quality of care for individuals living with myelofibrosis. Participants in this study will receive ruxolitinib orally starting 8 weeks before the transplantation and continuing until approximately 14 days prior to the conditioning regimen. After the transplant, they will receive ruxolitinib again until around 7 months post-transplant, followed by a gradual reduction over 2 months. The study also involves different conditioning regimens depending on the patient's specific needs, and various tests like CT scans, blood sample collections, and bone marrow biopsies to monitor the progress. The primary outcome measured is the incidence of a complication called graft versus host disease (GVHD), which will be compared to a fixed benchmark from a previous study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.79 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fred Hutch/University of Washington Cancer Consortium
Seattle, United StatesOpen Fred Hutch/University of Washington Cancer Consortium in Google Maps