Reduced Intensity Haploidentical Transplantation for Treating Primary or Secondary Myelofibrosis

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04370301

Provider View

This study is exploring a new approach to treat primary or secondary myelofibrosis using a reduced intensity haploidentical transplant, which involves using a partially matched donor. The goal is to reduce complications like graft versus host disease while ensuring the transplant is successful.

Patient Parameters

Program Overview

This study is testing a new method for treating myelofibrosis, a type of bone marrow disorder, by using a reduced intensity haploidentical transplant. This involves using a donor who is a partial match to the patient. The study aims to reduce the risk of graft versus host disease, a common complication, by using a JAK inhibitor medication before, during, and after the transplant. The initial phase showed promising results with no graft failures, and the new phase will continue to explore the effectiveness of this approach.

Description

In this study, patients with myelofibrosis will receive a treatment called a haploidentical transplant, which uses stem cells from a partially matched donor. The process involves several steps:

  1. JAK Inhibitor Therapy: Patients will take a JAK inhibitor medication for at least 8 weeks before starting the transplant process and continue it for 9-12 months after the transplant.

  2. Conditioning: Before the transplant, patients will receive medications and radiation to prepare their body. This includes melphalan and fludarabine given through an IV, and total-body irradiation.

  3. Transplant: On the day of the transplant, patients will receive stem cells from the donor through an IV.

  4. GVHD Prevention: To prevent graft versus host disease, patients will receive several medications, including cyclophosphamide, tacrolimus, and mycophenolate mofetil, along with a growth factor to help blood cell recovery.

Throughout the study, patients will undergo various tests, including MRI, CT scans, bone marrow biopsies, and heart function tests. Follow-up visits will occur between 80-100 days after treatment, at 1 year, and up to 5 years to monitor health and treatment outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be over 18 years old.
  • Diagnosed with primary or secondary myelofibrosis.
  • Classified as intermediate or high-risk disease.
  • Able to understand and sign a consent form.
  • Suitable candidate for a stem cell transplant.
  • Must have taken a JAK inhibitor for at least 8 weeks before the transplant.
  • Good overall health with a performance status score of 70 or higher.
  • Adequate kidney and liver function.
  • No severe liver disease.
  • Good lung and heart function.
  • Low comorbidity index.
  • Must have a suitable donor screened for compatibility.

Exclusion Criteria

  • Cannot take JAK inhibitors due to allergies or severe kidney or liver issues.
  • Active infections or HIV positive.
  • Pregnant or trying to conceive.
  • History of previous stem cell transplant.
  • Uncontrolled infections at the time of enrollment.
  • Recent severe fungal infections without specialist approval.
  • Availability of a fully matched donor.

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