Non Hodgkin Lymphoma Clinical Trial

Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL – (COASTAL)

Summary

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.

View Full Description

Full Description

This is an open label, randomized, two-arm Phase 3 study in subjects with relapsed or refractory FL and MZL to evaluate efficacy and safety of zandelisib in combination with rituximab in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP).

Subjects must have relapsed after at least one previous line of systemic immunochemotherapy. Previous treatments must have included an anti-CD20 monoclonal antibody (mAb) with chemotherapy such as Bendamustine (B), CHOP, CVP, FND, or similar regimens, or an anti-CD20 mAb with Lenalidomide (L).

Approximately 534 randomized subjects will be enrolled in this study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for subjects in Japan and Taiwan

Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:

FL Gr 1, Gr 2, or Gr 3a
MZL (splenic, nodal, or extra-nodal)
Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy
Subjects must have at least one bi-dimensionally measurable lesion >1.5 cm
Adequate hematologic parameters at screening unless abnormal values are due to disease
Adequate renal and hepatic function
Adequate cardiac function based on ECG and LVEF assessments

Exclusion Criteria:

Histologically confirmed diagnosis of FL Gr 3b or transformed disease
Prior therapy with PI3K inhibitors
Ongoing or history of drug-induced pneumonitis
Known lymphomatous involvement of the central nervous system
Tested positive for or active viral infection with hepatitis B or C virus
Tested positive or active infection with human immunodeficiency virus
Tested positive, or active infection with human T-cell leukemia virus type 1
Any uncontrolled clinically significant illness
History of clinically significant cardiovascular abnormalities such as congestive heart failure
History of clinically significant gastrointestinal (GI) conditions
Females who are pregnant

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

534

Study ID:

NCT04745832

Recruitment Status:

Recruiting

Sponsor:

MEI Pharma, Inc.

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There are 137 Locations for this study

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The Oncology Institute of Hope and Innovation
Tucson Arizona, 85745, United States
Orange Coast Memorial Medical Center
Fountain Valley California, 92708, United States
Long Beach Memorial Medical Center
Long Beach California, 90806, United States
The Oncology Institute of Hope and Innovation
Riverside California, 92506, United States
BRCR Medical Center Inc
Hollywood Florida, 33021, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Revive Research Institute
Farmington Hills Michigan, 48334, United States
Revive Research Institute
Sterling Heights Michigan, 48314, United States
Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center
Springfield Missouri, 65804, United States
Inspira Medical Center Mullica Hill
Mullica Hill New Jersey, 08062, United States
MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Alpha Research Institute, LLC
Baytown Texas, 77521, United States
Valley Cancer Associates
Harlingen Texas, 78550, United States
Community Cancer Trials of Utah
Ogden Utah, 84405, United States
Canberra Hospital
Garran , 2605, Australia
The Perth Blood Institute (PBI)
West Perth , 6005, Australia
Westmead Hospital
Westmead , 2145, Australia
AZ Sint-Jan Burgge-Oostende AV
Brugge , 8000, Belgium
UZ Brussel
Brussel , 1090, Belgium
Universitair Ziekenhuis Antwerpen
Edegem , 655, , Belgium
Center Hospitalier de Jolimont
Haine-Saint-Paul , 7100, Belgium
UZ Leuven Campus Gasthuisberg
Leuven , , Belgium
Eastern Regional Health Authority
Saint John's Newfoundland and Labrador, A1B3V, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie
Sherbrooke Quebec, JIH5N, Canada
McGill University Health Centre
Québec , H4A 3, Canada
CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte,
Clermont-Ferrand , 63003, France
Centre Hospitalier De Dunkerque - Service d'hématologie
Le Mans , 72000, France
Centre Hospitalier du Mans
Le Mans , 72000, France
Centre Leon Berard
Lyon , 69373, France
Hôpital Saint-Louis
Paris , 75010, France
CHU de Bordeaux - Maladies Du Sang, Centre François Magendie
Pessac , 33600, France
Centre Henri Becquerel, Service d'Hematologie
Rouen , 76038, France
CHU de Tours, Hôpital Bretonneau Centre
Tours Cedex 1 , 37044, France
Institut De Cancerologie Gustave Roussy
Villejuif , 94805, France
LTD Israeli-Georgian Medical Research Clinic "Helsicore"
Tbilisi , 0112, Georgia
M. Zodelava Hematology Center
Tbilisi , 0112, Georgia
J.S.C. K. Eristavi National Center of Experimental and Clinic
Tbilisi , 0159, Georgia
LTD "Medinvest" Institute of Hematology and Transfusiology
Tbilisi , 0186, Georgia
General Hospital of Athens "Laiko", Department of Haematology and Bone Marrow Transplantation
Athens , 11527, Greece
University General Hospital of Ioannina, Department of Haematology
Ioánnina , 455 0, Greece
University General Hospital of Patras "Panagia H. Voitheia"
Patras , 26504, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloníki , 57010, Greece
Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály
Budapest , H-112, Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika
Debrecen , H-403, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz,
Nyiregyhaza , H-440, Hungary
SOC Oncologia Medica e dei Tumori Immunocorrelati
Aviano , 33081, Italy
UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi
Bologna , 40138, Italy
U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle
Cuneo , 12100, Italy
U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi
Firenze , 50134, Italy
U.O. Clinica Ematologica
Genova , 16132, Italy
SC Oncologia Medica
Meldola , 47014, Italy
UOC Ematologia, Presidio Ospedaliero Papardo
Messina , 98158, Italy
UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre
Mestre , 30174, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milano , 20122, Italy
Dipartimento di Oncoematologia, Unità Linfomi, Ospedale
Milano , 20132, Italy
Divisione Oncoematologia, Istituto Europeo di Oncologia
Milano , 20141, Italy
Azienda Ospedaliera Ospedali Riuniti Via Sofia
Palermo , 90146, Italy
UO Ematologia, Ospedale Civile S.Maria delle Croci
Ravenna , 48121, Italy
UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna
Rimini , 47923, Italy
Istituti Fisioterapici Ospitalieri
Roma , 00144, Italy
S.C. Oncoematologia Azienda Ospedaliera Santa Maria
Terni , 05110, Italy
National Hospital Organization Nagoya Medical Center
Naka-ku Aichi, 460-0, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama-Shi Ehime, 791-0, Japan
National Hospital Organization Kyushu Cancer Center
Minami Fukuoka, 811-1, Japan
Gunma University Hospital
Maebashi Gunma, 371-8, Japan
Kobe City Medical Center General Hospital
Kobe Hyogo, 650-0, Japan
Kagoshima University Hospital
Sakuragaoka Kagoshima-Shi, Kagoshima, 890-8, Japan
University Hospital Kyoto Prefectural University of Medicine
Kamigyo-ku Kyoto, 602-8, Japan
Kindai University Hospital
Osakasayama-shi Osaka, 589-8, Japan
Anjo Kosei Hospital
Aichi , 446-8, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Aichi , 466-8, Japan
Aomori Prefectural Central Hospital
Aomori , 030-8, Japan
Chiba Cancer Center
Chiba , 260-8, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Chugoku Central Hospital
Hiroshima , 720-0, Japan
Hokkaido University Hospital
Hokkaido , 060-8, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto , 860-0, Japan
Kyoto University Hospital
Kyoto , 606-8, Japan
National University Corporation Tohoku University Hospital
Miyagi , 980-8, Japan
Aichi Cancer Center Hospital
Nagoya , 464-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Osaka University Hospital
Osaka , 565-0, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo , 113-8, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Tokyo , 135-8, Japan
Keio University Hospital
Tokyo , 160-8, Japan
Inje University Busan Paik Hospital
Busan , 47392, Korea, Republic of
Dong-A university Hospital
Busan , 49201, Korea, Republic of
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Kyungpook National University Hospital
Daegu , 41944, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollyang , 58128, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea
Seoul , 06591, Korea, Republic of
Ewka Womans University Mokdong Hospital
Seoul , 07985, Korea, Republic of
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of
Albert Schweizer Ziekenhuis, Hematology Department
Dordrecht , 3318, Netherlands
Spaarne Gasthuis, Oncology Department
Hoofddorp , 2134, Netherlands
Canterbury District Health Board, Haematology Department
Christchurch , 8011, New Zealand
Dunedin Hospital, Southern Blood and Cancer Service
Dunedin , 9016, New Zealand
Klinika Hematologii, Szpital Uniwersytecki
Bydgoszcz , 85-16, Poland
Pratia MCM Krakow
Kraków , 30-51, Poland
ARS Medical - Szpital, Oddzial hematologiczny
Piła , 64-92, Poland
Centrum Medyczne Pratia Poznan
Skorzewo , 60-18, Poland
University Clinical Center of Serbia, Clinic for Hematology
Belgrade , 11000, Serbia
Zvezdara University Medical Center, Clinical department for Hematology and Oncology
Belgrade , 11000, Serbia
Clinical Hospital Center "Zemun", Clinic for Internal Medicine, Department for Hematology
Belgrade , 11080, Serbia
Oncology Institute of Vojvodina, Clinic for Internal Oncology
Kamenica , 21204, Serbia
University Clinical Center Kragujevac, Clinic for Hematology
Kragujevac , 34000, Serbia
Clinical Center of Vojvodina, Clinic for Hematology
Novi Sad , 21000, Serbia
Hospital Universitario Quironsalud
Alcorcón Madrid, 28223, Spain
Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology
Barcelona , 08035, Spain
Hospital Universitario Mútua Terrassa
Barcelona , 08221, Spain
Institut Catalá d'Oncologia, Hospital Duran i Reynals
Barcelona , 08908, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Complejo Hospitalario de Navarra
Navarro , 31008, Spain
Hospital Universitario de Canarias
Santa Cruz De Tenerife , 38320, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain
China Medical University Hospital
Taichung , 40433, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
Chi Mei Hospital
Tainan City , 73657, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
Gazi University Health Research and Application Hospital, Hematology Department
Ankara , 29 06, Turkey
Istanbul University Istanbul Medical Faculty, Hematology Department
Istanbul , 34093, Turkey
Erciyes University Medical Faculty, Department of Hematology
Kayseri , 38039, Turkey
Ondokuz Mayis University Medical Faculty, Hematology Department
Samsun , 55200, Turkey
Namik Kemal University Hospital
Tekirdağ , 59100, Turkey
Karadeniz Technical University Medical Faculty Department of Hematology
Trabzon , 61080, Turkey
North Wales Cancer Treatment Centre
Bodelwyddan Denbighshire, LL18 , United Kingdom
Royal Cornwall Hospital
Cornwell , TR1 3, United Kingdom
Department of Haematology St. George's University of London
London , SW17 , United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
London , SW3 6, United Kingdom
Imperial College Healthcare NHS Trust Hammersmith Hospital
London , W12 0, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Genesis Care Oxford
Oxford , OX4 6, United Kingdom
University Hospitals Plymouth NHS Trust, Derriford Hopital
Plymouth , PL6 8, United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
Surrey Quays , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

534

Study ID:

NCT04745832

Recruitment Status:

Recruiting

Sponsor:


MEI Pharma, Inc.

How clear is this clinincal trial information?

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