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Stem Cell Transplantation
Pre-Transplant JAK Inhibitor for Myelofibrosis
Phase 2
Waitlist Available
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
Patients meeting the criteria for intermediate-1, intermediate-2 or high-risk disease by the Dynamic International Prognostic Scoring System (DIPSS) or DIPSS-plus scoring system
Diagnosis of primary MF (PMF) as defined by the 2008 World Health Organization classification system or diagnosis of secondary MF as defined by the International Working Group (IWG) for Myeloproliferative Neoplasms Research and Treatment criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether a JAK inhibitor can improve transplant outcomes for patients with myelofibrosis by being given before the transplant.
Who is the study for?
This trial is for patients with primary or secondary myelofibrosis, a type of bone marrow cancer. Participants should have certain risk levels by DIPSS scores, good physical function (Karnofsky >= 70), adequate kidney and liver function, no severe lung issues, and not be on supplemental oxygen. They must understand the study and consent to participate. Pregnant or breastfeeding individuals, those with HIV or uncontrolled infections, prior transplants are excluded.Check my eligibility
What is being tested?
The trial tests if taking a JAK inhibitor drug called ruxolitinib before receiving stem cells from a donor can improve outcomes for myelofibrosis patients. The treatment aims to reduce symptoms like spleen enlargement and help the new stem cells work better in producing healthy blood cells after transplant.See study design
What are the potential side effects?
Potential side effects include risks associated with ruxolitinib such as infection risk increase due to immune system suppression, liver problems, anemia (low red blood cell count), bruising or bleeding easily due to low platelets. Transplant-related side effects may include graft-versus-host disease where donor cells attack patient's body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is considered intermediate-1, intermediate-2, or high-risk.
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I have been diagnosed with primary or secondary myelofibrosis according to specific medical guidelines.
Select...
My kidney function, measured by creatinine clearance, is good.
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My donor is a near-perfect match for my transplant.
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I am able to care for myself but may not be able to do active work.
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I do not have severe liver problems or diseases that affect my liver function.
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I may be eligible for a stem cell transplant.
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I have been on ruxolitinib for at least 8 weeks and can continue it until 4 days before my transplant.
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My bone marrow donor is a sibling who is a complete or near-complete match.
Select...
I do not use supplemental oxygen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2-year Overall Survival (OS) in Patients With Myelofibrosis (MF) Who Receive Treatment With a JAK Inhibitor Followed by an Allogeneic Transplant
Secondary outcome measures
Non-relapse Mortality (NRM)
Number of Patients Who Experienced Primary Graft Failure/Rejection
Number of Patients Who Experienced Secondary Graft Failure/Poor Graft Function
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ruxolitinib, transplant)Experimental Treatment12 Interventions
Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; 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
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Melphalan
2008
Completed Phase 3
~1500
Methotrexate
2013
Completed Phase 4
~3800
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Ruxolitinib
2018
Completed Phase 3
~1140
Tacrolimus
2011
Completed Phase 4
~4740
Total-Body Irradiation
1997
Completed Phase 3
~1180
Umbilical Cord Blood Transplantation
2009
Completed Phase 2
~470
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,184 Total Patients Enrolled
11 Trials studying Primary Myelofibrosis
552 Patients Enrolled for Primary Myelofibrosis
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,207 Total Patients Enrolled
12 Trials studying Primary Myelofibrosis
582 Patients Enrolled for Primary Myelofibrosis
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,104 Total Patients Enrolled
24 Trials studying Primary Myelofibrosis
3,329 Patients Enrolled for Primary Myelofibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have a closely matched donor for a transplant.My condition is considered intermediate-1, intermediate-2, or high-risk.I have been diagnosed with primary or secondary myelofibrosis according to specific medical guidelines.My kidney function, measured by creatinine clearance, is good.My donor is a near-perfect match for my transplant.I have had a fungal infection in the past 6 months without seeing an infectious disease specialist.My total bilirubin level is below 3 mg/dL, or high due to Gilbert's disease or hemolysis.My samples for tests are usually taken from my blood, not my bone marrow.I am able to care for myself but may not be able to do active work.My treatment will use one or two umbilical cord blood units to meet the cell dose needed.I do not have severe liver problems or diseases that affect my liver function.I am eligible for a cord blood transplant with specific matching and cell dose criteria.My cord blood transplant matches 4-6 of my HLA markers.I am HIV positive.I do not have any ongoing serious infections.I have had a transplant from another person.I am not pregnant or breastfeeding, or if I am, I haven't started ruxolitinib before joining.I may be eligible for a stem cell transplant.I do not have any uncontrolled infections.I have been on ruxolitinib for at least 8 weeks and can continue it until 4 days before my transplant.My bone marrow donor is a sibling who is a complete or near-complete match.I do not use supplemental oxygen.I have a history of HIV infection.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ruxolitinib, transplant)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other published cases of Umbilical Cord Blood Transplantation?
"There are presently 1294 Umbilical Cord Blood Transplantation studies. Of these, 235 are clinical trials that are ongoing. Most of the research is based in Philadelphia, Pennsylvania; however, there are 35067 locations running trials for this treatment across the world."
Answered by AI
To what ailments is Umbilical Cord Blood Transplantation commonly given as a treatment?
"leukemia, lung cancers and small cell lung cancer (sclc) are all forms of cancer that can be treated with Umbilical Cord Blood Transplantation."
Answered by AI
What has been the general consensus on Umbilical Cord Blood Transplantation's safety?
"While Phase 2 trials don't have the same level of data to support efficacy, there is safety data available which gives Umbilical Cord Blood Transplantation a score of 2."
Answered by AI
How many participants will this trial have in total?
"This study is not recruiting at this time. The trial was initially posted on 10/20/2014, with the last update being on 6/17/2022. For those looking for other studies, there are 751 clinical trials for primary myelofibrosis and 1294 Umbilical Cord Blood Transplantation studies that are still seeking participants."
Answered by AI
Are there any vacancies left in this test group for willing participants?
"No, this particular clinical trial is no longer recruiting patients. The initial posting date was October 20th, 2014 and the most recent edit was on June 17th, 2022. For those still looking to participate in a study, there are 751 trials for primary myelofibrosis and 1294 Umbilical Cord Blood Transplantation studies that are actively searching for participants."
Answered by AI
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