Is NCT07228624 recruiting in Seattle, WA?

Yes, NCT07228624 is currently recruiting participants at its Seattle, WA location. This myelodysplastic/myeloproliferative neoplasm clinical trial is actively enrolling qualified participants.

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.

Myelodysplastic/Myeloproliferative Neoplasm Clinical Trial in Seattle, WA

Q: How do I join the myelodysplastic/myeloproliferative neoplasm 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.

About This Myelodysplastic/Myeloproliferative Neoplasm Study in Seattle

This phase II trial tests the effect of adding ruxolitinib to standard graft versus host disease (GVHD) prevention in treating older patients with myelofibrosis (MF) or myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap syndromes before, during, and after a donor (allogeneic) hematopoietic cell transplant (HCT). Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. Giving chemotherapy, such as cytoxan and busulfan or fludarabine and melphalan, before a donor transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving standard prevention (prophylaxis) therapies, such as tacrolimus and methotrexate, after the transplant may stop this from happening. Methotrexate, a type of antifolate, is in a class of medications called antimetabolites. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill cancer cells. Tacrolimus is used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Ruxolitinib, a type of Janus-associated kinase (JAK) inhibitor, blocks a protein called JAK, which may help keep abnormal blood cells or cancer cells from growing. It may also lower the body's immune response and prevent the development of GVHD. Giving ruxolitinib before, during and after allogeneic HCT in addition to standard GVHD prophylaxis may be safe, tolerable and effective in preventing GVHD and improving outcomes in older patients with MF or MDS/MPN overlap syndrome.

Sponsor: Fred Hutchinson Cancer Center

Who Can Participate

Inclusion Criteria

PART 1 JAK INHIBITOR ADMINISTRATION: Age 18-75 years

Patients \> 75 must be considered an HCT candidate, meet all protocol criteria and have comorbidity score =\< 3 and Karnofsky performance status (KPS) \> or = to 90. Patients. \> 75 who do not meet these criteria may be presented at PCC for consensus exception

PART 1 JAK INHIBITOR ADMINISTRATION: Disease criteria

Diagnosis of primary or secondary MF as defined by the 2022 World Health Organization classification system or the International Consensus Classification for Myeloid and Acute Leukemias

Diagnosis of an MDS/MPN overlap syndrome as defined by the 2022 World Health Organization

PART 1 JAK INHIBITOR ADMINISTRATION: Ability to understand and the willingness to sign a written informed consent document

PART 1 JAK INHIBITOR ADMINISTRATION: Patient must be a potential HCT candidate as assessed by the consenting physician

PART 1 JAK INHIBITOR ADMINISTRATION: Patient must be agreeable to taking a JAK-inhibitor (ruxolitinib preferred) for at least 8 consecutive weeks immediately prior to conditioning and be willing to take ruxolitinib 5mg BID starting from day -4 prior to and continuing until 12 months post-transplant as tolerated followed by a 6-month taper.

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Meeting criteria for Part 1 at time of initiation of JAK-inhibitor, including the ability to understand and willingness to sign a written informed consent. Patients arriving to our institution for HCT and not enrolled in Part 1 may still be enrolled in Part 2 if Part 1 criteria are met. These patients will have Part 1 endpoints transcribed from their medical records

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Received a JAK-inhibitor for at least 8 weeks immediately prior to conditioning and be willing to take Rux from day -4 at the 5mg BID dose until 12 months post-transplant as tolerated followed by a 6 month taper

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Performance status score

Karnofsky ≥ 70 or \> 90 for patients \> 75 years old

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: HCT-CI Score \< 8; if patient is \> 75 years old HCT-CI \< 3

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Calculated creatinine clearance using the Cockcroft-Gault formula or 24-hour urine creatinine clearance must be \> 60 ml/min

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Total serum bilirubin must be \< 3mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Transaminases must be \< 3 x the upper limit of normal

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: 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 \> 3mg/dL, and symptomatic biliary disease will be excluded

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Diffusion capacity of lung for carbon monoxide (DLCO) corrected \> 60% normal. Patient may not be on oxygen

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Left ventricular ejection fraction \> 40%

DONOR: Human leukocyte antigen (HLA)-matched sibling donor

DONOR: 10 of 10 HLA-matched unrelated donor

DONOR: 9 of 10 allele or antigen mismatched unrelated donor

DONOR: Peripheral blood is preferred over bone marrow

DONOR: Matched unrelated donors may be preferred over siblings if the unrelated donor is \< 30 years and the sibling is \> 60 years. However, sibling donors \< 70 should be preferred over mismatched unrelated donors

Exclusion Criteria

PART 1 JAK INHIBITOR ADMINISTRATION: Contraindication to receiving ruxolitinib including patients who have known hypersensitivity to JAK inhibitors and excipients

PART 1 JAK INHIBITOR ADMINISTRATION: History of prior allogeneic transplant

PART 1 JAK INHIBITOR ADMINISTRATION: Leukemic transformation (\> 20% blasts)

PART 1 JAK INHIBITOR ADMINISTRATION: Uncontrolled viral, bacterial, or fungal infection despite being on therapy

PART 1 JAK INHIBITOR ADMINISTRATION: History of HIV infection

PART 1 JAK INHIBITOR ADMINISTRATION: History of untreated tuberculosis (TB)

PART 1 JAK INHIBITOR ADMINISTRATION: Pregnant or breastfeeding

PART 1 JAK INHIBITOR ADMINISTRATION: Patients with history of myocardial infarction (MI), cerebrovascular accident (CVA) or unprovoked pulmonary embolism (PE)/deep vein thrombosis (DVT) in the past 6 months

PART 1 JAK INHIBITOR ADMINISTRATION: Secondary malignancy in last 5 years with \> 20% risk of relapse

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Contraindication to receiving ruxolitinib including patients who have known hypersensitivity to JAK inhibitors and excipients

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: History of prior allogeneic transplant

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Leukemic transformation (\> 20% blasts)

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Uncontrolled viral or bacterial infection at the time of transplant data review and consent conference

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: History of HIV infection

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: History of untreated TB

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Requiring supplemental oxygen

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Pregnant or breastfeeding

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Secondary malignancy in last 5 years with \> 20% risk of relapse

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Patients with a history of MI, CVA, or unprovoked PE/DVT in the past 6 months

PART 2 ALLOGENEIC STEM CELL TRANSPLANT: Patients without an HLA-identical sibling donor, 10 of 10 HLA-matched or 9 of 10 mismatched 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 (NCT07228624) 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.

Myelodysplastic/Myeloproliferative Neoplasm Treatment Options in Seattle, WA

If you're searching for myelodysplastic/myeloproliferative neoplasm treatment options in Seattle, WA, this clinical trial (NCT07228624) 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 phase 2 clinical trial. You'll receive care from experienced myelodysplastic/myeloproliferative neoplasm 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 myelodysplastic/myeloproliferative neoplasm clinical trials near you to find additional studies recruiting in your area.

Myelodysplastic/Myeloproliferative Neoplasm Clinical Trial in Seattle, WA

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