رادار التجارب AI | ||
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حالة التجربة السريرية NCT04509700 لـ أورام الخلايا البائية الخبيثة هي نشط (لا يقبل مشاركين جدد). اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
إنسايتRollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) المرحلة الثانية ١١٢ تجربة مفتوحة علاج مركب
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT04509700 مصممة لدراسة علاج لـأورام الخلايا البائية الخبيثة. إنها تجربة تدخُّلية من المرحلة الثانية وهي نشط (لا يقبل مشاركين جدد). بدأت في ١٣ ذو الحجة ١٤٤١ هـ مع خطة لتجنيد ١١٢ مشاركًا. تقودها إنسايت، ومن المتوقع اكتمالها بحلول ٢٩ ربيع الآخر ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٩ جمادى الآخرة ١٤٤٧ هـ.
الملخص
This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib.
وصف مفصل
The purpose of this study is to provide continued use of parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib to participants who are currently enrolled in an Incyte-sponsored study and receiving the same treatment, who have at least stable disease, who are obtaining clinical benefit (in the opinion of the investigator) on the current study treatment, as defined by the parent Protoc...عرض المزيد
العنوان الرسمي
A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
الحالات الطبية
أورام الخلايا البائية الخبيثةمعرّفات دراسة أخرى
- INCB 50465-801
- 2022-501687-18-00 (معرف السجل) (EU CT Number)
- 2019-004948-30 (رقم EudraCT)
NCT معرّف
تاريخ البدء (فعلي)
2020-08-03
آخر تحديث مُنشور
2025-12-10
تاريخ الاكتمال (المقدر)
2027-09-30
عدد المشاركين المخطط لهم
١١٢
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الثانية
الحالة
نشط (لا يقبل مشاركين جدد)
الكلمات الرئيسية
non-Hodgkin lymphoma
phosphatidylinositol 3-kinase
myeloproliferative neoplasm
phosphatidylinositol 3-kinase
myeloproliferative neoplasm
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
غير عشوائي
نموذج التدخل
المجموعة الواحدة
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةparsaclisib Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover. | parsaclisib Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover. |
تجريبيةparsaclicib + itacitinib Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover. | parsaclisib + itacitinib Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover. |
تجريبيةparsaclisib + ruxolitinib Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover. | parsaclisib + ruxolitinib Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover. |
تجريبيةparsaclisib + ibrutinib Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover. | parsaclisib + ibrutinib Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover. |
النتيجة الرئيسية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related AEs | Through study completion, an average of 5 years |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib.
- Currently tolerating treatment in the parent Protocol.
- Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination therapy with Itacitinib, ruxolitinib, or ibrutinib as determined by the investigator.
- Has at least stable disease, as determined by the investigator.
- Has demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
- Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis, and any other study procedures indicated in this Protocol.
- Willingness to avoid pregnancy or fathering children
- Ability to comprehend and willingness to sign an ICF
- Has been permanently discontinued from study treatment in the parent Protocol for any reason.
- Able to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib therapy outside a clinical study.
- Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
- Pregnant or breastfeeding women.
إنسايتلا توجد بيانات اتصال.
105 مواقع الدراسة في 17 بلدان
Alabama
Uab Comprehensive Cancer Center, Birmingham, Alabama, 35233, United States
University of Alabama At Birmingham, Birmingham, Alabama, 35233, United States
Arizona
Mayo Clinic Rochester, Phoenix, Arizona, 85054, United States
University of Arizona Cancer Center-Out Pt., Tucson, Arizona, 85719, United States
California
City of Hope National Medical Center, Duarte, California, 31010, United States
California Cancer Associates For Research and Excellence, Fresno, California, 93720, United States
Innovative Clinical Research Institute, Long Beach, California, 90805, United States
Colorado
Rocky Mountain Cancer Center, Aurora, Colorado, 80012, United States
Illinois
Rush University Medical Center-Consultants in Hematology, Chicago, Illinois, 60612, United States
Kansas
University of Kansas Hospital Authority, Westwood, Kansas, 66205, United States
Maryland
Rcca Md, Llc, Bethesda, Maryland, 20817, United States
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Michigan
University of Michigan Cancer Center, Ann Arbor, Michigan, 48109, United States
Mississippi
Hattiesburg Clinic Hematology, Hattiesburg, Mississippi, 39401, United States
Missouri
Saint Luke'S Hospital of Kansas City, Kansas City, Missouri, 64111, United States
Hca Midwest Health-Research Medical Center, Kansas City, Missouri, 66211, United States
Nevada
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, 89169, United States
New York
Roswell Park Cancer Institute, Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
Ohio
University Hospitals Case Medical Center, Cleveland, Ohio, 44106, United States
Cleveland Clinic, Cleveland, Ohio, 44195, United States
The Ohio State University, Columbus, Ohio, 43210, United States
Oregon
Knight Cancer Institute At Oregon Health and Science University, Portland, Oregon, 97239, United States
Texas
Baylor Scott White Univeristy Medical Center, Dallas, Texas, 75246, United States
Washington
University of Washington-Seattle Cancer Care Alliance, Seattle, Washington, 98109-4405, United States
Medical University of Vienna, Vienna, 01090, Austria
Cliniques Universitaires Ucl Saint-Luc, Brussels, 01200, Belgium
Universitair Ziekenhuis Gent (Uz Gent), Ghent, 09000, Belgium
Az Groeninge, Kortrijk, 08500, Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg, Leuven, 03000, Belgium
University Hospital Hradec Kralove, Hradec Králové, 50005, Czechia
Univerzita Karlova V Praze 1. Lekarska Fakulta, Prague, 128 00, Czechia
Fakultni Nemocnice V Motole, Prague, 15000, Czechia
University Hospital Kralovkse Vinohrady, Prague, Czechia
Aarhus University Hospital, Århus N, 08200, Denmark
Rigshospitalet, Copenhagen, 02100, Denmark
Sjaellands Universitetshospital, Roskilde, 04000, Denmark
Chru de Brest Hospital Morvan, Brest, 29200, France
Centre Antoine Laccassagne, Nice, 06189, France
Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris), Paris, 75010, France
Hospital Universitaire Pitie-Salpetriere, Paris, 75013, France
Centre Hospitalier Universitaire de Toulouse, Toulouse, 31059, France
Chru Hopitaux de Tours Hospital Bretonneau, Tours, 37000, France
Petz Aladar County Teaching Hospital, Győr, 09024, Hungary
Hadassah Hebrew University Medical Center Ein Karem Hadassah, Jerusalem, 91120, Israel
Rabin Medical Center - Beilinson Hospital, Petah Tikva, 49100, Israel
Sheba Medical Center, Tel Litwinsky, 5265601, Israel
University of Bologna Institute of Haematology L E A Seragnoli, Bologna, 40126, Italy
Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or, Bologna, 40138, Italy
Azienda Ospedaliero-Universitaria Careggi (Aouc), Florence, 50134, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori, Meldola (FC), 47014, Italy
Fondazione Irccs Ca Granda Ospedale Maggiore, Milan, 20122, Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milan, 20133, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan, 20162, Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milan, 22162, Italy
Universita Di Napoli Federico Ii, Naples, 80131, Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara, Novara, 28100, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo, 90146, Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara, Pisa, 56126, Italy
Ospedale Santa Maria Delle Croci, Ravenna, 48121, Italy
Ospedale Sant. Eugenio, Roma, 00144, Italy
Juntendo University Hospital, Bunkyō City, 113-8431, Japan
National Cancer Center Hospital, Chūō, 104-0045, Japan
Kansai Medical University Hospital, Hirakata, 573-1191, Japan
Tokai University Hospital, Isehara, 259-1193, Japan
Irb of Kobe City Medical Center General Hospital, Kobe, 650-0047, Japan
University Hospital Kyoto Prefectural University of Medicine, Kyoto, 602-8566, Japan
Nho Matsumoto Medical Center, Matsumoto-shi, 399-8701, Japan
Miyagi Cancer Center, Miyagi, 981-1293, Japan
Jrc Aichi Medical Center Nagoya Daini Hospital, Nagoya, 466-8650, Japan
Niigata Cancer Center Hospital, Niigata, 951-8566, Japan
Osaka Metropolitan University Hospital, Osaka, 545-8585, Japan
Hokuyukai Sapporo Hokuyu Hospital, Sapporo, 003-0006, Japan
National Hospital Org. Hokkaido Cancer Center, Sapporo, 003-0804, Japan
Tohoku University Hospital, Sendai, 980-8574, Japan
Tokyo Medical University Hospital, Shinjuku, 160-0023, Japan
Tenri Hospital, Tenri, 632-8552, Japan
Nippon Medical School Hospital, Tokyo, 113-8603, Japan
Yokohama Municipal Citizens Hospital, Yokohama, 221-0855, Japan
University of Fukui Hospital, Yoshida-gun, 910-1193, Japan
Haukeland University Hospital, Bergen, 05021, Norway
Sp Zoz Szpital Uniwersytecki, Kracow, 31-501, Poland
Wwcoit Im. M. Kopernika W Lodzi, Lodz, 93-513, Poland
Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu, Nowy Sącz, 33-300, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1, Wroclaw, 20-081, Poland
The Catholic University of Korea Seoul St. Mary'S Hospital, Seoul, 06591, South Korea
Hospital General Unviersitario de Alicante, Alicante, 03010, Spain
Germans Trias I Pujol, Badalona, 08916, Spain
Hospital Del Mar, Barcelona, 08003, Spain
Hospital Clinic Barcelona, Barcelona, 08036, Spain
Hospital Clinic I Provincial, Barcelona, 08036, Spain
Start Madrid - Ciocc, Boadilla del Monte, 28660, Spain
Institut Catala Doncologia - Hospital Duran I Reynals, L'Hospitalet de Llobregat, 08908, Spain
Hospital General Universitario Gregorio Maranon, Madrid, 28009, Spain
Hospital Universitario Fundacin Jimnez Daz, Madrid, 28040, Spain
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
Hospital Universitario Hm Sanchinarro, Madrid, 28050, Spain
Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón, 28233, Spain
Hospital Clinico Universitario de Salamanca, Salamanca, 37007, Spain
Hospital Universitario Virgen Del Rocio, Seville, 41013, Spain
Karolinska University Hospital Solna, Stockholm, 171 76, Sweden
Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi, Istanbul, 34214, Turkey (Türkiye)
Ege University Hospital, Izmir, 35040, Turkey (Türkiye)
Birmingham Heartlands Hospital, Birmingham, B9 5SS, United Kingdom