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New combo approach aims to tame transplant complications in bone marrow cancer

NCT ID NCT04370301

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study is for people with myelofibrosis, a type of bone marrow cancer. It tests whether giving a JAK inhibitor drug before, during, and after a half-matched stem cell transplant can lower the risk of graft-versus-host disease (a common complication where donor cells attack the body) without raising the chance of graft failure. About 20 adults aged 18 to 70 with intermediate or high-risk disease will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * PART 1: JAK INHIBITOR ADMINISTRATION INCLUSION CRITERIA * Age between 18 and 70 years * Diagnosis of primary myelofibrosis (PMF) as defined by the 2016 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 * Patients meeting the criteria for intermediate-1, intermediate-2 or high-risk disease by the Dynamic International Prognostic Scoring System (DIPSS)-plus scoring system (DIPSS may be used if all data from DIPSS are not available) * Ability to understand and the willingness to sign a written informed consent document (or legally authorized representative) * Patient must be a potential hematopoietic stem cell transplant candidate * PART 2: ALLOGENEIC STEM CELL TRANSPLANT INCLUSION CRITERIA * Meeting criteria for 1st phase as above, at time of initiation of JAK inhibitor, including ability to understand and willingness to sign a written informed consent (or legally authorized representative). Patients arriving to our institution for transplant and not enrolled in Part 1 may still be enrolled in Part 2 if Part 1 criteria met. These patients will have Part 1 endpoints transcribed from medical records * Received JAK inhibitor for at least 8 weeks immediately prior to conditioning and be willing to continue until 9-12 months post-transplant as tolerated * Karnofsky performance status score \>= 70 * Calculated creatinine clearance using the Cockcroft-Gault formula or 24 hour (hr) urine creatinine clearance must be \> 60 ml/min * Total serum bilirubin must be \< 3 mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis * Transaminases must be \< 3 x the upper limit of normal * Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension. Patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3 mg/dL, and symptomatic biliary disease will be excluded * Diffusion capacity of the lung for carbon monoxide (DLCO) corrected \> 60% normal; may not be on supplemental oxygen * Left ventricular ejection fraction \> 40% OR shortening fraction \> 26% * Comorbidity Index \< 5 at the time of pre-transplant evaluation * DONOR: Patients must be screened prior to transplant for donor-specific anti-HLA antibodies (DSA). Patients with DSA will be reviewed by the principal investigator and considered for desensitization treatment * DONOR: Children are preferred over siblings and parents * DONOR: Younger donors are preferred over older donors * DONOR: ABO matched donors are preferred over minor ABO mismatched and over major ABO mismatch donors Exclusion Criteria: * PART 1: JAK INHIBITOR ADMINISTRATION EXCLUSION CRITERIA * Contraindication to receiving a JAK inhibitor including: * Patients who have known hypersensitivity to JAK inhibitors * Clinical or laboratory evidence of significant renal or hepatic impairment including cirrhosis * Active uncontrolled infection * Known human immunodeficiency virus (HIV) positivity * Women who are pregnant or trying to conceive * Caution should be used in patients with platelets \< 100 though adjustments in dose can be made to accommodate anyone with platelets \> 50 * History of prior allogeneic transplant * Leukemic transformation (\> 20% blasts) * PART 2: ALLOGENEIC STEM CELL TRANSPLANT EXCLUSION CRITERIA * Uncontrolled viral or bacterial infection at the time of study enrollment * Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval * Known HIV positivity * Pregnant or breastfeeding * Availability of an human leukocyte antigen (HLA)-identical or 1-allele-mismatched related donor or an HLA 10 of 10 matched unrelated donor

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Fred Hutch/University of Washington Cancer Consortium

    RECRUITING

    Seattle, Washington, 98109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.