Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms

Inclusion Criteria

• •At least 18 years of age at the time of signing the informed consent form (ICF)
• •Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2
• •Must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• •Willing and able to adhere to the study visit schedule and other protocol requirements.
• •Philadelphia chromosome negative myeloproliferative disease (including polycythemia vera, myelofibrosis, and essential thrombocytosis, chronic myelomonocytic leukemia, atypical chronic myelogenous leukemia, myelodysplastic syndrome/myeloproliferative neoplasm-unclassified, MPN not otherwise specified) having undergone first allogeneic HCT.
• •Engraftment including \>95% myeloid cell donor chimerism and Absolute neutrophil count (ANC) \> 1.0 x 109/L
• •Platelets \> 50 x 109/L with no platelet transfusions in the prior 7 days
• •Absence of disease progression as defined by International Working Group (IWG) Myeloproliferative Neoplasm Response Criteria
• •Acute GVHD of the skin is permitted if prednisone has been tapered to \<0.25 mg/kg with continued response
• •Females of childbearing potential (FCBP) must:
• •1. Have a negative pregnancy tests as verified by the Investigator during screening prior to enrollment (a second pregnancy test will be collected prior to therapy as below). She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence\* from heterosexual contact.
• •2. Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use and be able to comply with highly effective contraception\*\* without interruption, -14 days prior to starting investigational product, during the study treatment (including dose interruptions), and for 30 days after discontinuation of study treatment.
• •Note: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
• •Male participants must:
• •Practice true abstinence\* (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 30 days following investigational product discontinuation, or longer if required for each compound and/or by local regulations, even if he has undergone a successful vasectomy.
• •\* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception).
• •\*\* Agreement to use highly effective methods of contraception that alone or in combination resulting in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly throughout the course of the study. Such methods include: Combined (estrogen and progestogen containing) hormonal contraception: Oral; Intravaginal; Transdermal; Progestogen-only hormonal contraception associated with inhibition of ovulation: Oral; Injectable hormonal contraception; Implantable hormonal contraception; Placement of an intrauterine device; Placement of an intrauterine hormone-releasing system; Bilateral tubal occlusion; Vasectomized partner.