Myeloproliferative Neoplasms Clinical Trial
To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)
The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy.
Prospective participants must be on stable doses of ruxolitinib ranging from 5 mg BID to 25 mg BID and will have been on that dose for at least the last 8 weeks prior to Day 1. At least 3 months duration of prior ruxolitinib is required. Participants must meet Protocol-defined criteria for suboptimal response to ruxolitinib monotherapy. 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 a participant has completed the week 24 assessments, the participant's treatment assignment will then be unblinded and if found to be placebo, the participant will have the opportunity to crossover 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.
Treated with ruxolitinib for ≥ 3 months with a stable dose for at least the last 8 weeks prior to Day 1
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 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 used for MF (whether for treatment of MF or another indication) with the exception of ruxolitinib, within 3 months of starting study drug, and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better.
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
Unwillingness to receive RBC transfusions to treat low hemoglobin levels.
Known hypersensitivity or severe reaction to parsaclisib or ruxolitinib or excipients of parsaclisib/matching placebo or ruxolitinib formulations.
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There are 172 Locations for this study
Berkeley California, 94704, United States
Fresno California, 93720, United States
Los Angeles California, 90027, United States
Redlands California, 92373, 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
Augusta Georgia, 30912, United States
Indianapolis Indiana, 46202, United States
Westwood Kansas, 66205, United States
New Orleans Louisiana, 70112, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, 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
Hawthorne New York, 10532, United States
New York New York, 10029, United States
New York New York, 10065, United States
Clyde North Carolina, 28721, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15232, United States
Memphis Tennessee, 38120, United States
Dallas Texas, 75230, United States
Dallas Texas, 75246, United States
Dallas Texas, 75390, United States
Houston Texas, 77005, United States
Houston Texas, 77025, United States
Everett Washington, 98201, United States
Wien , 01140, Austria
Brugge , 08000, Belgium
Hasselt , 3500, Belgium
Roeselare , 8800, Belgium
Yvoir , 05530, Belgium
Beijing , 10004, China
Beijing , 10005, China
Beijing , 10009, China
Beijing , 10019, China
Changchun , 13002, China
Changzhou , 21300, China
Fuzhou , 35000, China
Guangzhou , 51051, China
Hangzhou , 31000, China
Harbin , 15001, China
Hefei , 23002, China
Hohhot , 10050, China
Jinan , 25001, China
Kunming , 65010, China
Lanzhou , 73000, China
Lanzhou , 73003, China
Nanchang , 33000, China
Nanchang , 33000, China
Nanjing , 21002, China
Qingdao , 26600, China
Shenyang , 11000, China
Shenzhen , 51805, China
Tianjin , 30005, China
Tianjin , 51008, China
Wuhan , 43002, China
Wuhan , 43003, China
Xi'an , 71000, China
Yantai , 26400, China
Zhengzhou , 45000, China
Zhengzhou , 45000, China
Helsinki , FI-00, Finland
La Tronche , 38700, France
Limoges Cedex , 87042, France
Limoges Cedex , 87042, France
Nantes , 44093, France
Nimes , 30900, France
Paris , 75010, France
Paris , 75012, France
Pierre-Benite , 69495, France
Toulouse , 31059, France
Vandoeuvre-les-nancy , 54500, France
Bonn , 53127, Germany
Greifswald , 17475, Germany
Halle (saale) , 06120, Germany
Rostock , 18057, Germany
Budapest , 01088, Hungary
Eger , 03300, Hungary
Gyor , 09024, Hungary
Ashdod , 77476, Israel
Haifa , 31999, Israel
Jerusalem , 91120, Israel
Rehovot , 76100, Israel
Tel Aviv , 64239, Israel
Tel Aviv , 69710, Israel
Avellino , 83100, Italy
Bari , 70124, Italy
Bologna , 40138, Italy
Catania , 11111, Italy
Florence , 50134, Italy
Genova , 16132, Italy
Milano , 20122, Italy
Napoli , 80131, Italy
Novara , 28100, Italy
Palermo , 90146, Italy
Perugia , 06156, Italy
Perugia , 6156, Italy
Pescara , 65124, Italy
Pisa , 56126, Italy
Reggio Calabria , 89133, Italy
Roma , 00161, Italy
Roma , 00168, Italy
Roma , 144, Italy
Rome , 00168, Italy
Siena , 53100, Italy
Taranto , 74123, Italy
Udine , 33100, Italy
Varese , 21100, Italy
Fukuoka , 812-8, Japan
Himeji-shi , 670-8, Japan
Hirakata , 573-1, Japan
Isehara , 25911, Japan
Izunokuni , 410-2, Japan
Kagoshima , 890-8, Japan
Kitakyushu-shi , 807-8, Japan
Kobe-shi , 650-0, Japan
Kumamoto-shi , 862-8, 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
Tokyo , 113-8, Japan
Tokyo , 113-8, Japan
Yamanashi , 409-3, Japan
Busan , 49241, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Bergen , 05021, Norway
Lorenskog , 01478, Norway
Katowice , 40-04, Poland
Katowice , 41-08, Poland
Krakow , 31-50, Poland
Lublin , 20-08, Poland
Warszawa , 02-77, Poland
Bucharest , 30171, Romania
Târgu Mureș , 54013, Romania
Alicante , 03010, Spain
Badalona , 08916, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Las Palmas de Gran Canaria , 35010, Spain
Madrid , 24041, Spain
Madrid , 28040, Spain
Murcia , 30008, Spain
Murcia , 30120, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Valencia , 46000, Spain
Valencia , 46017, Spain
Zaragoza , 50009, Spain
Kaohsiung City , 83301, Taiwan
Taichung , 00404, Taiwan
Tainan , 00704, Taiwan
Adana , 01250, Turkey
Ankara , 06500, Turkey
Istanbul , 34214, Turkey
Istanbul , 34662, Turkey
Izmir , 35040, Turkey
Samsun , 55200, Turkey
Aberdeen , AB15 , United Kingdom
Boston , PE21 , United Kingdom
Gloucester , GL1 3, United Kingdom
London , NW1 2, United Kingdom
Middlesbrough , TS4 3, United Kingdom
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