To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)
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|ClinicalTrials.gov Identifier: NCT04551066|
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : April 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Myelofibrosis Primary Myelofibrosis Post Essential Thrombocythemia Myelofibrosis Post Polycythemia Vera Myelofibrosis||Drug: parsaclisib Drug: ruxolitinib Drug: placebo||Phase 3|
This is a Phase 3, randomized, double-blind study of the combination of the PI3Kδ inhibitor parsaclisib or matching placebo and the JAK1/2 inhibitor ruxolitinib in participants with PMF or secondary MF (PPV-MF or PET-MF) with DIPSS risk category of intermediate or high. Prospective participants must have not received prior MF therapy with a JAK inhibitor or a PI3K inhibitor. After participants have been determined to be eligible for the study and completed the baseline symptom diary assessment for 7 days, they will be randomized to 1 of 2 treatment groups, with stratification for platelet count (≥ 100 × 10^9/L vs 50 to < 100 × 10^9/L inclusive) and DIPSS risk category (high vs intermediate-2 vs intermediate-1).
Once all enrolled participants completed the week 24 assessments the study will be unblinded and and participants randomized to placebo will have the opportunity to cross over to begin receiving parsaclisib, together with continued ruxolitinib, as long as hematology parameters are adequate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Triple blind|
|Official Title:||A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kδ Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis|
|Estimated Study Start Date :||March 31, 2021|
|Estimated Primary Completion Date :||September 26, 2023|
|Estimated Study Completion Date :||February 27, 2026|
Experimental: Group A : parsaclisib + ruxolitinib
Participants will receive parsaclisib and ruxolitinib starting from Day 1 for the duration of study, ruxolitinib dose will be determined by baseline platelet count.
parsaclisib will be administered QD orally
Other Name: INCB050465
ruxolitinib will be administered BID orally
Placebo Comparator: Group B : placebo + ruxolitinib
Participants will receive placebo and ruxolitinib starting from Day 1 for the duration of study, ruxolitinib dose will be determined by baseline platelet count.
ruxolitinib will be administered BID orally
placebo will be administered QD orally
- Proportion of participants achieving targeted reduction in spleen volume [ Time Frame: Baseline to Week 24 ]Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
- Proportion of participants who have a targeted reduction in Total Symptom Score (TSS) [ Time Frame: Baseline to Week 24 ]Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
- Change in TSS [ Time Frame: Baseline to Week 24 ]Change in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
- Time to the first ≥ 50% reduction in TSS [ Time Frame: Baseline to Week 24 ]Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
- Overall Survival (OS) [ Time Frame: Up to approximately 36 months ]OS is defined as randomization date to death due to any cause.
- Number of Treatment Emergent Adverse Events (TEAE) [ Time Frame: Up to approximately 36 months ]Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 35 days after last dose of study drug.
- Time of onset of targeted reduction in spleen volume [ Time Frame: Baseline to Week 144 ]Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
- Duration of maintenance of targeted reduction in spleen volume [ Time Frame: Baseline to Week 144 ]Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551066
|Contact: Incyte Corporation Call Center (US)||email@example.com|
|Contact: Incyte Corporation Call Center (ex-US)||+800 firstname.lastname@example.org|
|United States, Alaska|
|Alaska Oncology and Hematology, LLC||Not yet recruiting|
|Anchorage, Alaska, United States, 99508|
|United States, California|
|Fresno, California, United States, 93720|
|United States, Missouri|
|Midamerica Cancer Care||Recruiting|
|Kansas City, Missouri, United States, 64114|
|United States, New Jersey|
|New Jersey Hematology Oncology Associates Llc||Recruiting|
|Brick, New Jersey, United States, 08724|
|United States, Oregon|
|Kaiser Permanente - Northwest||Recruiting|
|Portland, Oregon, United States, 97227|
|United States, South Dakota|
|Avera Cancer Institute||Recruiting|
|Sioux Falls, South Dakota, United States, 57103|
|United States, Texas|
|Houston, Texas, United States, 77005|
|Hospital General Universitari Vall D Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Study Director:||Albert Assad, M.D||Incyte Corporation|