Myeloproliferative Neoplasms Clinical Trial
To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)
The purpose of the study is to compare the efficacy of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis.
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.
Diagnosis of PMF, PPV-MF, or PET-MF.
DIPSS risk category of intermediate-1, intermediate-2, or high.
Palpable spleen of ≥ 5 cm below the left costal margin on physical examination at the screening visit.
Active symptoms of MF at the screening visit, as demonstrated by the presence of a TSS of ≥ 10 using the Screening Symptom Form.
Participants with an ECOG performance status score of 0, 1, or 2.
Screening bone marrow biopsy specimen and pathology report(s) available that was obtained within the prior 2 months or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24 and every 24 weeks there after. Screening/baseline biopsy specimen must show diagnosis of MF.
Life expectancy of at least 24 weeks.
Willingness to avoid pregnancy or fathering children.
Prior use of any JAK inhibitor.
Prior therapy with any drug that inhibits PI3K (examples of drugs targeting this pathway include but are not limited to INCB040093, idelalisib, duvelisib, buparlisib, copanlisib, and umbralisib).
Use of experimental drug therapy for MF or any other standard drug (eg, danazol, hydroxyurea) used for MF within 3 months of starting study drug and/or lack of recovery from all toxicities from previous therapy to ≤ Grade 1.
Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
Recent history of inadequate bone marrow reserve.
Inadequate liver and renal function at screening.
Active bacterial, fungal, parasitic, or viral infection that requires therapy.
Active HBV or HCV infection that requires treatment or at risk for HBV reactivation.
Known HIV infection.
Uncontrolled, severe, or unstable cardiac disease that in the investigator's opinion may jeopardize the safety of the participant or compliance with the Protocol.
Active invasive malignancy over the previous 2 years.
Splenic irradiation within 6 months before receiving the first dose of study drug.
Concurrent use of any prohibited medications.
Active alcohol or drug addiction that would interfere with the ability to comply with the study requirements.
Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives(whichever is longer) before the first dose of study drug or anticipated during the study.
Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
Currently breastfeeding or pregnant.
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
History of Grade 3 or 4 irAEs from prior immunotherapy.
Receipt of any live vaccine within 30 days of the first dose of study drug
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There are 168 Locations for this study
Anchorage Alaska, 99508, United States
Phoenix Arizona, 85054, United States
Berkeley California, 94704, United States
Fresno California, 93720, United States
Los Angeles California, 90027, United States
Los Angeles California, 90095, United States
San Diego California, 92103, United States
San Luis Obispo California, 93401, United States
Stamford Connecticut, 06904, United States
Washington District of Columbia, 20057, United States
Atlanta Georgia, 30322, United States
Westwood Kansas, 66205, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Kansas City Missouri, 64114, United States
Brick New Jersey, 08724, United States
Morristown New Jersey, 07960, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States
Hawthorne New York, 10532, United States
New York New York, 10029, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Portland Oregon, 97227, United States
Portland Oregon, 97239, United States
Sioux Falls South Dakota, 57103, United States
Dallas Texas, 75246, United States
Houston Texas, 77005, United States
Houston Texas, 77025, United States
Houston Texas, 77030, United States
Everett Washington, 98201, United States
Seattle Washington, 98109, United States
Linz , 04020, Austria
St. Polten , 03100, Austria
Wien , 01140, Austria
Wien , 01140, Austria
Brugge , 08000, Belgium
Brussels , 01000, Belgium
Brussels , 1000, Belgium
Charleroi , 06000, Belgium
Hasselt , 03500, Belgium
Roeselare , 08800, Belgium
Baoding , 71000, China
Beijing , 10004, China
Beijing , 10009, China
Changchun , 13002, China
Changsha , 41000, China
Fuzhou , 35000, China
Guangzhou , 51008, China
Guangzhou , 51051, China
Hangzhou , 31000, China
Harbin , 15001, China
Hefei , 23000, China
Hohhot , 10050, China
Jinan , 25001, China
Lanzhou , 73000, China
Lanzhou , 73003, China
Nanchang , 33000, China
Nanchang , 33000, China
Nanjing , 21002, China
Shanghai , 20003, China
Shenzhen , 51805, China
Shijiazhuang , 50000, China
Tianjin , 30005, China
Wenzhou , 32500, China
Wuhan , 43002, China
Yantai , 26400, China
Zhengzhou , 45000, China
Aalborg , 9000, Denmark
Odense , 5000, Denmark
Helsinki , FI-00, Finland
La Tronche , 38700, France
Le Chesnay , 78157, France
Limoges , 87042, France
Nantes , 44093, France
Nimes , 30900, France
Paris , 75010, France
Pierre-benite , 69495, France
Poitiers , 86021, France
Rennes , 35033, France
Halle (saale) , 06120, Germany
Rostock , 18057, Germany
Beer Yaaqov , 70300, Israel
Haifa , 31999, Israel
Jerusalem , 91120, Israel
Petah-tikva , 49100, Israel
Rehovot , 76100, Israel
Tel Aviv-yafo , 64239, Israel
Tel Aviv , 69710, Israel
Bologna , 40138, Italy
Catania , 95123, Italy
Genova , 16132, Italy
Meldola , 47014, Italy
Milano , 20122, Italy
Milan , 20132, Italy
Napoli , 80131, Italy
Palermo , 90146, Italy
Pesaro , 61122, Italy
Reggio Calabria , 89133, Italy
Roma , 00133, Italy
Roma , 00161, Italy
Roma , 00168, Italy
Rome , 00168, Italy
Salerno , 84131, Italy
Taranto , 74123, Italy
Udine , 33100, Italy
Varese , 21100, Italy
Verona , 37134, Italy
Chiba , 260-8, Japan
Chuo , 409-3, Japan
Fukuoka , 812-8, Japan
Himeji-shi , 670-8, Japan
Hirakata , 573-1, Japan
Isehara , 25911, Japan
Kagoshima-shi , 890-8, Japan
Kitakyushu-shi , 807-8, Japan
Kobe-shi , 650-0, Japan
Miyazaki , 889-1, Japan
Nagoya-shi , 453-8, Japan
Ogaki , 50385, Japan
Osaka , 545-8, Japan
Saitama , 343-8, Japan
Sapporo , 003-0, Japan
Sendai , 980-8, Japan
Tokyo , 113-8, Japan
TSU , 514-0, Japan
Yokohama-shi , 221-0, Japan
Seoul , 03080, Korea, Republic of
Seoul , 03651, Korea, Republic of
Seoul , 06591, Korea, Republic of
Wonju , 26426, Korea, Republic of
Bergen , 05021, Norway
Lorenskog , 01478, Norway
Katowice , 40-02, Poland
Katowice , 41-51, Poland
Krakow , 31-50, Poland
Lublin , 20-08, Poland
Warszawa , 02-77, Poland
Alicante , 3010, Spain
Badalona , 8916, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Barcelona , 08908, Spain
Barcelona , 08916, Spain
Barcelona , 8003, Spain
Bilbao , 48013, Spain
El Palmar , 30120, Spain
Granada , 18014, Spain
Las Palmas de Gran Canaria , 35010, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Murcia , 30008, Spain
Salamanca , 37007, Spain
Valencia , 46000, Spain
Valencia , 46017, Spain
Adana , 01250, Turkey
Ankara , 06500, Turkey
Istanbul , 34214, Turkey
Istanbul , 34662, Turkey
Izmir , 35040, Turkey
Izmir , 35340, Turkey
Samsun , 55200, Turkey
Boston , PE21 , United Kingdom
Gloucester , GL1 3, United Kingdom
London , EC1A , United Kingdom
London , NW1 2, United Kingdom
Sheffield , S5 7A, United Kingdom
Stoke-on-trent , ST4 6, United Kingdom
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