Study of Stem Cell Transplant vs. Non-Transplant Therapies in High-Risk Myelofibrosis

Sponsor
University Health Network, Toronto
Study ID
NCT04217356
Status
Active Not Recruiting

Conditions

  • Bone Marrow Cancer
  • High-Risk Cancer
  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Hematopoietic stem cell transplant — BIOLOGICAL
    Intravenous infusion of hematopoietic stem cells from a donor.
  • Ruxolitinib — DRUG
    Ruxolitinib is type of drug called a janus kinase (JAK) inhibitor. Ruxolitinib is taken orally (by mouth).
  • Hydroxyurea — DRUG
    Hydroxyurea is a type of drug called an antimetabolite. Hydroxyurea is taken orally (by mouth).

Study Details

The purpose of this research study is to see how effective hematopoietic stem cell transplantation (HCT) is compared to best available non-transplant therapies (BAT) in patients with high risk myelofibrosis. This will be done by asking participants to choose the treatment that they prefer to receive (HCT or BAT) and then comparing the outcomes of the participants in both treatment groups.

Key Dates

Start date
Aug 5, 2020
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: Hematopoietic stem cell transplant (HCT)
    Standard of care hematopoietic stem cell transplant with a matched donor.
  • Arm: Best available non-transplant therapies (BAT)
    Standard of care treatment with a janus kinase (JAK) inhibitor drug called ruxolitinib or treatment with an antimetabolite drug called hydroxyurea.

Primary Outcome Measure

Number of patients allocated to hematopoietic stem cell transplantation (HCT) [ Time Frame: 5 years ]

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