Is NCT04370301 recruiting in Seattle, WA?

Yes, NCT04370301 is currently recruiting participants at its Seattle, WA location. This primary myelofibrosis clinical trial is actively enrolling qualified participants.

How do I join the primary myelofibrosis clinical trial in Seattle?

To join this clinical trial in Seattle, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Seattle clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Primary Myelofibrosis Clinical Trial in Seattle, WA

About This Primary Myelofibrosis Study in Seattle

This initial cohort of this phase II trial studied the outcomes of using a JAK inhibitor prior to reduced intensity haploidentical (Haplo) transplantation for the treatment of primary or secondary myelofibrosis (MF). The primary risk of using Haplo HCT in patients with MF is graft failure. In the first cohort, all patients engrafted. There were no instances of graft failure. However, a large number of patients did have graft versus host disease as a complication of their transplant. JAK inhibitors have since been approved for the indication of graft versus host disease treatment. And we are also using them for graft versus host disease prevention in a study of MF patients with sibling and unrelated donors. Therefore, we are opening a new cohort of the current study using the JAK inhibitor prior to, during and after Haplo transplant. Our goal is to decrease graft versus host disease in patients receiving a Haplo MF transplant without increasing the risk of graft failure.

Sponsor: Fred Hutchinson Cancer Center

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Seattle?

Yes, this clinical trial (NCT04370301) has an active research site in Seattle, WA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Primary Myelofibrosis Treatment Options in Seattle, WA

If you're searching for primary myelofibrosis treatment options in Seattle, WA, this clinical trial (NCT04370301) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Seattle research site is actively enrolling participants for this clinical trial. You'll receive care from experienced primary myelofibrosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all primary myelofibrosis clinical trials near you to find additional studies recruiting in your area.

Primary Myelofibrosis Clinical Trial in Seattle, WA

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