Myeloproliferative Neoplasms Clinical Trial

To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

440

Study ID:

NCT04551066

Recruitment Status:

Recruiting

Sponsor:

Incyte Corporation

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There are 168 Locations for this study

See Locations Near You

Alaska Oncology
Anchorage Alaska, 99508, United States
Mayo Clinic Rochester
Phoenix Arizona, 85054, United States
Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center
Berkeley California, 94704, United States
CCARE
Fresno California, 93720, United States
California Research Institute (Cri)
Los Angeles California, 90027, United States
UCLA School of Medicine
Los Angeles California, 90095, United States
Scripps Clinic
San Diego California, 92103, United States
Coastal Integrated Cancer Care - Cicc
San Luis Obispo California, 93401, United States
Stamford Hospital - Medical Oncology Hematology
Stamford Connecticut, 06904, United States
Georgetown University
Washington District of Columbia, 20057, United States
Emory University
Atlanta Georgia, 30322, United States
University of Kansas Hospital Authority
Westwood Kansas, 66205, United States
University of Kentucky - Markey Cancer Center
Lexington Kentucky, 40536, United States
Tulane University
New Orleans Louisiana, 70112, United States
Johns Hopkins University
Baltimore Maryland, 21287, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Midamerica Cancer Care
Kansas City Missouri, 64114, United States
New Jersey Hematology Oncology Associates Llc
Brick New Jersey, 08724, United States
Morristown Medical Center - Atlantic Health System
Morristown New Jersey, 07960, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Westchester Medical Center Advanced Oncology and Infusion Center
Hawthorne New York, 10532, United States
Mount Sinai School of Medicine
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Duke Cancer Center
Durham North Carolina, 27710, United States
Wake Forest Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Kaiser Permanente - Northwest
Portland Oregon, 97227, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57103, United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
Renovatio Clinical
Houston Texas, 77005, United States
Kelsey Seybold Clinic
Houston Texas, 77025, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
Providence Regional Medical Center Everett
Everett Washington, 98201, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Ordensklinikum Linz Gmbh Elisabethinen
Linz , 04020, Austria
Universitaetsklinikum St. Poelten
St. Polten , 03100, Austria
Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse
Wien , 01140, Austria
Hanusch-Krankenhaus Wiener Gebietskrankenkasse
Wien , 01140, Austria
A.Z. St.-Jan A.V.
Brugge , 08000, Belgium
Cliniques Universitaires Ucl Saint-Luc
Brussels , 01000, Belgium
Cliniques Universitaires Ucl Saint-Luc
Brussels , 1000, Belgium
Grand Hospital de Charleroi
Charleroi , 06000, Belgium
Jessa Ziekenhuis
Hasselt , 03500, Belgium
AZ DELTA
Roeselare , 08800, Belgium
Affiliated Hospital of Hebei University
Baoding , 71000, China
Peking University People'S Hospital (Pkuph) - Institute of Hematology
Beijing , 10004, China
Peking University Third Hospital
Beijing , 10009, China
The First Hospital of Jilin University
Changchun , 13002, China
Xiangya Hospital Central South University
Changsha , 41000, China
Fujian Medical University Union Hospital
Fuzhou , 35000, China
Guangdong Provincial of People Hospital
Guangzhou , 51008, China
Nanfang Hospital
Guangzhou , 51051, China
The First Affiliated Hospital of Zhejiang University
Hangzhou , 31000, China
Harbin Institute of Hematology and Oncology
Harbin , 15001, China
Anhui Provincial Hospital
Hefei , 23000, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot , 10050, China
Jinan Central Hospital
Jinan , 25001, China
The First Hospital of Lanzhou University
Lanzhou , 73000, China
Lanzhou University Second Hospital
Lanzhou , 73003, China
Jiangxi Provincial of People Hospital
Nanchang , 33000, China
The First Affiliated Hospital of Nanchang University
Nanchang , 33000, China
Jiangsu Province Hospital
Nanjing , 21002, China
Zhongshan Hospital Fudan University
Shanghai , 20003, China
Shenzhen University Hospital
Shenzhen , 51805, China
The Second Hospital of Hebei Medical University
Shijiazhuang , 50000, China
Tianjin Medical University General Hospital
Tianjin , 30005, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , 32500, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan , 43002, China
Yantai Yuhuangding Hospital
Yantai , 26400, China
Henan Provincial Peoples Hospital
Zhengzhou , 45000, China
Aalborg University Hospital
Aalborg , 9000, Denmark
Odense University Hospital
Odense , 5000, Denmark
Helsinki University Central Hospital
Helsinki , FI-00, Finland
Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
La Tronche , 38700, France
Centre Hospitalier de Versailles - Hopital Andre Mignot
Le Chesnay , 78157, France
Chu Limoges - Hopital Dupuytren
Limoges , 87042, France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes , 44093, France
Chu Nimes
Nimes , 30900, France
Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)
Paris , 75010, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-benite , 69495, France
Hospital de La Miletrie
Poitiers , 86021, France
Chu de Rennes - Hospital Pontchaillou
Rennes , 35033, France
Universitatsklinikum Halle (Saale)
Halle (saale) , 06120, Germany
Universitaetsmedizin Rostock
Rostock , 18057, Germany
Assaf Harofeh Medical Center
Beer Yaaqov , 70300, Israel
Rambam Health Care Campus
Haifa , 31999, Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem , 91120, Israel
Davidoff Cancer Center Rabin Medical Center
Petah-tikva , 49100, Israel
Kaplan Medical Center
Rehovot , 76100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv-yafo , 64239, Israel
Assuta Ramat Hahayal
Tel Aviv , 69710, Israel
Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or
Bologna , 40138, Italy
Azienda Policlinico Vittorio Emanuele
Catania , 95123, Italy
Universita Degli Studi Di Genova - Facolta Di Medicina E Chirurgia
Genova , 16132, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
Meldola , 47014, Italy
Fondazione Irccs Ca Granda Ospedale Maggiore
Milano , 20122, Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milan , 20132, Italy
Universita Di Napoli Federico Ii
Napoli , 80131, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo , 90146, Italy
Aormn Hospital Hematology and Bmt Center
Pesaro , 61122, Italy
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria , 89133, Italy
Universita Di Roma Tor Vergata
Roma , 00133, Italy
Universita Di Roma
Roma , 00161, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Roma , 00168, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome , 00168, Italy
Aou San Giovanni Di Dio E Ruggi D'Aragona
Salerno , 84131, Italy
Azienda Ospedaliera San Giuseppe Moscati
Taranto , 74123, Italy
Azienda Sanitaria Universitaria Friuli Centrale Asu Fc
Udine , 33100, Italy
A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi
Varese , 21100, Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona , 37134, Italy
Chiba Cancer Center
Chiba , 260-8, Japan
University of Yamanashi Hospital
Chuo , 409-3, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Japanese Red Cross Society Himeji Hospital
Himeji-shi , 670-8, Japan
Kansai Medical University Hospital
Hirakata , 573-1, Japan
Tokai University Hospital
Isehara , 25911, Japan
Kagoshima University Hospital
Kagoshima-shi , 890-8, Japan
Hospital of the University of Occupation and Environmental Health
Kitakyushu-shi , 807-8, Japan
Kobe City Medical Center General Hospital
Kobe-shi , 650-0, Japan
University of Miyazaki Hospital
Miyazaki , 889-1, Japan
Japanese Red Cross Nagoya Daini Hospital
Nagoya-shi , 453-8, Japan
Ogaki Municipal Hospital
Ogaki , 50385, Japan
Osaka Metropolitan University Hospital
Osaka , 545-8, Japan
Dokkyo Medical University Saitama Medical Center
Saitama , 343-8, Japan
Hokuyukai Sapporo Hokuyu Hospital
Sapporo , 003-0, Japan
Tohoku University Hospital
Sendai , 980-8, Japan
Juntendo University Hospital
Tokyo , 113-8, Japan
Mie University Hospital
TSU , 514-0, Japan
Yokohama Municipal Citizens Hospital
Yokohama-shi , 221-0, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 03651, Korea, Republic of
The Catholic University of Korea Seoul St. Mary?S Hospital
Seoul , 06591, Korea, Republic of
Wonju Severance Christian Hospital
Wonju , 26426, Korea, Republic of
Haukeland University Hospital
Bergen , 05021, Norway
Akershus University Hospital
Lorenskog , 01478, Norway
Samodzielny Publiczny Szpital Kliniczny Im. Andrzeja Mielckiego
Katowice , 40-02, Poland
Pratia Hematologia Katowice
Katowice , 41-51, Poland
Sp Zoz Szpital Uniwersytecki
Krakow , 31-50, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin , 20-08, Poland
Institute of Hematology and Transfusion Medicine
Warszawa , 02-77, Poland
Hospital General Unviersitario de Alicante
Alicante , 3010, Spain
Ico Hospital Germans Trias I Pujol
Badalona , 8916, Spain
Hospital Del Mar
Barcelona , 08003, Spain
Hospital General Universitario Vall D Hebron
Barcelona , 08035, Spain
Ico-Hospital Duran I Reynals
Barcelona , 08908, Spain
Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
Barcelona , 08908, Spain
Ico Hospital Germans Trias I Pujol
Barcelona , 08916, Spain
Hospital Del Mar
Barcelona , 8003, Spain
Hospital de Basurto
Bilbao , 48013, Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar , 30120, Spain
Hospital Universitario Virgen de Las Nieves
Granada , 18014, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria , 35010, Spain
Fundacian Jimnez Diaz
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital General Universitario Morales Meseguer
Murcia , 30008, Spain
Hospital Clinico Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitari I Politecnic La Fe
Valencia , 46000, Spain
Hospital Universitario Doctor Peset
Valencia , 46017, Spain
Baskent University Adana Hospital
Adana , 01250, Turkey
Gazi University Hospital Gazi University Faculty of Medicine
Ankara , 06500, Turkey
Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi
Istanbul , 34214, Turkey
Baskent University Istanbul Hospital
Istanbul , 34662, Turkey
Ege University Hospital
Izmir , 35040, Turkey
Dokuz Eylul University
Izmir , 35340, Turkey
Ondokuz Mayis University Medicine Faculty
Samsun , 55200, Turkey
United Lincolnshire Hospitals
Boston , PE21 , United Kingdom
Gloucestershire Royal Hospital
Gloucester , GL1 3, United Kingdom
Barts Health NHS Trust - St. Bartholomews Hospital
London , EC1A , United Kingdom
University College London Hospitals Nhs Foundation Trust
London , NW1 2, United Kingdom
Sheffield Teaching Hospitals Nhs Foundation Trust - Weston Park Hospital
Sheffield , S5 7A, United Kingdom
University Hospital of North Midlands Nhs Trust
Stoke-on-trent , ST4 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

440

Study ID:

NCT04551066

Recruitment Status:

Recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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