Myelofibrosis Clinical Trial
Official title:
A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy
This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | February 1, 2023 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of primary MF meeting the 2016 WHO criteria for overt PMF or secondary MF (PPV-MF or PET-MF) meeting the 2008 IWG-MRT criteria. - At least Intermediate 1 risk MF according to the DIPSS. - Prior treatment with ruxolitinib and/or fedratinib monotherapy - Currently receiving ruxolitinib or fedratinib monotherapy for PMF or secondary MF. - Splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume = 450 cm3 on imaging assessed during screening. - Allogeneic stem cell transplant not planned. - Platelet is greater than or equal to 50 × 109/L at screening. - Ability to comprehend and willingness to sign a written ICF for the study. - Willingness to avoid pregnancy or fathering children. Exclusion Criteria: - Prior treatment with a JAK inhibitor other than ruxolitinib or fedratinib - Record of = 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening - For participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents - Treatment with ruxolitinib, fedratinib or other MF-directed therapy (approved or investigational) within 2 weeks of Day 1 - Prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib - Unable or unwilling to undergo serial MRI or CT scans for spleen volume measurement - Unable or unwilling to complete MFSAF v4.0 diary on a daily basis during the study - ECOG performance status = 3 - Life expectancy less than 24 weeks - Not willing to receive RBC or platelet transfusions - Participants with laboratory values at screening outside of protocol defined ranges - Significant concurrent, uncontrolled medical condition - Participants with impaired cardiac function or clinically significant cardiac disease unless approved by medical monitor/sponsor - History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful - Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment. - Evidence of HBV or HCV infection or risk of reactivation - Known HIV infection. |
Country | Name | City | State |
---|---|---|---|
United States | New Jersey Hematology Oncology Associates Llc | Brick | New Jersey |
United States | Renovatio Clinical Consultants Llc | Spring | Texas |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1 : Treatment Emergent Adverse Events (TEAE'S) | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment. | 24 Weeks | |
Primary | Part 2 : Spleen Volume Reduction by MRI/CT Scan | Defined as the proportion of participants who have a reduction in spleen volume (by imaging) of at least 35 percent when compared with baseline. | 24 weeks | |
Secondary | Part 2 : Treatment Emergent Adverse Events (TEAE'S) | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment. | 13 months | |
Secondary | Part 2 : Improvement in Total Symptom Score (TSS) | Defined as the proportion of participants who achieve at least 50 percent reduction in TSS over the 28 days immediately before the end of Week 24 compared with the 7 days immediately before the initiation of itacitinib IR (baseline). | 24 Weeks | |
Secondary | Part 2 : Improvement in quality of life. | Defined as the mean change in the 5 multi-item functional scale scores and the multi-item global health status scale score (EORTC QLQ-C30). | 24 weeks | |
Secondary | Part 2 : Improvement in Patient Global Impression of Change (PGIC) | Defined as percentage of participants who are categorized as improved | 24 Weeks |
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