Study on Ruxolitinib Before, During, and After Stem Cell Transplant in Older Patients with Myelofibrosis and Related Blood Disorders

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT07228624

Provider View

This clinical trial is exploring the use of the drug ruxolitinib alongside standard treatments to prevent complications in older patients undergoing stem cell transplants for myelofibrosis or related blood disorders.

Patient Parameters

Program Overview

This study is testing whether adding the drug ruxolitinib to standard treatments can help prevent complications in older patients with myelofibrosis or related blood disorders who are receiving a stem cell transplant. The transplant involves receiving blood-forming stem cells from a donor to replace damaged cells. Ruxolitinib may help prevent a condition where the new cells attack the body, known as graft versus host disease (GVHD).

Description

The study is divided into two parts:

Part 1: Patients will take ruxolitinib or a similar drug for at least 8 weeks before starting the transplant process. They will continue taking ruxolitinib twice a day for 12 months, then once a day until 18 months. Patients will receive chemotherapy to prepare their body for the transplant.

Part 2: Patients will receive the stem cell transplant. They will also receive medications to prevent GVHD, including tacrolimus and methotrexate. Patients will undergo various tests, including blood tests and scans, before and after the transplant to monitor their health.

After the treatment, patients will have follow-up visits at specific intervals to check their progress and health.

Eligibility Criteria

Inclusion Criteria

  • Aged 18-75 years, or over 75 if meeting specific health criteria.
  • Diagnosed with myelofibrosis or a related blood disorder.
  • Able to understand and sign a consent form.
  • Eligible for a stem cell transplant and willing to take ruxolitinib as part of the treatment.
  • Have a suitable donor for the transplant, either a matched sibling or unrelated donor.
  • Meet specific health and organ function criteria, including heart and lung function.

Exclusion Criteria

  • Allergic to ruxolitinib or similar drugs.
  • Previous stem cell transplant.
  • Uncontrolled infections or certain viral infections like HIV or untreated tuberculosis.
  • Pregnant or breastfeeding.
  • Recent history of heart attack, stroke, or blood clots.
  • Other cancers with a high risk of returning.
  • No suitable donor for the transplant.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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