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JAK Inhibitor
Peritransplant Ruxolitinib for Myelofibrosis
Phase 2
Recruiting
Led By Rachel B. Salit
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Potential hematopoietic stem cell transplant candidate
Meeting criteria for intermediate-1, intermediate-2 or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS) or DIPSS plus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
Study Summary
This trial is testing whether a drug can help prevent a condition where the transplanted cells from a donor can attack the body's normal cells and improve transplant outcomes in patients with primary and secondary myelofibrosis.
Who is the study for?
This trial is for adults over 18 with primary or secondary myelofibrosis, classified as intermediate-1, -2, or high-risk. Participants must have used ruxolitinib for at least 8 weeks before the transplant and be able to continue post-transplant. They should not have severe kidney or liver problems, uncontrolled infections, HIV, or be pregnant. A suitable stem cell donor is required.Check my eligibility
What is being tested?
The study tests if ruxolitinib given before, during, and after a stem cell transplant can prevent graft versus host disease and improve outcomes in myelofibrosis patients. It involves chemotherapy drugs like Melphalan and Fludarabine followed by transplantation of donor stem cells.See study design
What are the potential side effects?
Ruxolitinib may cause side effects such as anemia (low red blood cells), bruising/bleeding issues due to low platelets, dizziness/fainting from low blood pressure; other drugs involved also carry risks of infection risk increase and organ damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I might be a candidate for a bone marrow transplant.
Select...
My condition is classified as intermediate-1, intermediate-2, or high-risk.
Select...
I am able to care for myself but may not be able to do active work.
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I have been diagnosed with primary or secondary myelofibrosis.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of grade II-IV graft versus host disease (GVHD) in myelofibrosis patients
Secondary outcome measures
Incidence of chronic GVHD
Incidence of grade III-IV GVHD
Incidence of primary and secondary graft failure
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ruxolitinib, conditioning, HSCT, GVHD prophylaxis)Experimental Treatment10 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Busulfan
2008
Completed Phase 3
~1120
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Ruxolitinib
2018
Completed Phase 3
~1140
Tacrolimus
2011
Completed Phase 4
~4740
Melphalan
2008
Completed Phase 3
~1500
Methotrexate
2013
Completed Phase 4
~3800
Cyclophosphamide
1995
Completed Phase 3
~3770
Total-Body Irradiation
1997
Completed Phase 3
~1180
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,200 Total Patients Enrolled
11 Trials studying Primary Myelofibrosis
568 Patients Enrolled for Primary Myelofibrosis
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,223 Total Patients Enrolled
12 Trials studying Primary Myelofibrosis
598 Patients Enrolled for Primary Myelofibrosis
Rachel B. SalitPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
117 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
71 Patients Enrolled for Primary Myelofibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I might be a candidate for a bone marrow transplant.I have an infection that is not under control.I do not have any uncontrolled infections.I have no known allergies or adverse reactions to ruxolitinib.I do not have severe kidney or liver problems.I have had a fungal infection without consulting an infectious disease specialist.I have been on ruxolitinib for at least 8 weeks and can continue it for 9 months after my transplant.My condition is classified as intermediate-1, intermediate-2, or high-risk.I am able to care for myself but may not be able to do active work.I have been diagnosed with primary or secondary myelofibrosis.My blood cancer has not transformed into a more aggressive form.I am 18 years old or older.I have a history of HIV infection.I am willing to start ruxolitinib treatment within 6 months.My platelet count is below 100, or I've had a transplant from another person.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ruxolitinib, conditioning, HSCT, GVHD prophylaxis)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Total-Body Irradiation been accorded authorization from the FDA?
"Total-Body Irradiation has been determined to be moderately safe, as it received a score of 2. This is because while there are some data affirming its safety, none exists in regards to its efficacy."
Answered by AI
Could you please detail any prior experiments involving Total-Body Irradiation?
"Currently, 1243 studies into Total-Body Irradiation are being conducted. Of those trials, 229 of them belong to Phase 3 and originate in Philadelphia, Pennsylvania with 34827 locations offering these treatments."
Answered by AI
Is this experiment currently recruiting participants?
"Indeed, the pertinent data from clinicaltrials.gov affirms that this medical trial remains open for enrollment. It was initially posted to the site on December 18th 2020 and received its last update on June 21st 2022. 45 participants are needed at a single location."
Answered by AI
How many volunteers are being accepted into this medical research project?
"Affirmative. Clinicaltrials.gov provides evidence that recruitment for this medical trial is ongoing, having been first published on December 18th 2020 and most recently modified on June 21st 2022. 45 volunteers are needed to be recruited from a single location."
Answered by AI
What maladies can Total-Body Irradiation be employed to treat?
"Total-Body Irradiation is an effective therapy for leukemia and a number of other illnesses such as lung cancer, small cell lung cancer (SCLC), atopic dermatitis, and more."
Answered by AI
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