Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
- Conditions
- Follicular Lymphoma (FL)Marginal Zone LymphomaNon Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT04745832
- Lead Sponsor
- MEI Pharma, Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 82
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rituximab plus chemotherapy Rituximab Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab plus chemotherapy Bendamustine Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab plus chemotherapy CHOP Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab plus Zandelisib Zandelisib Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Rituximab plus Zandelisib Rituximab Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles
- Primary Outcome Measures
Name Time Method Progression Free Survival 1 year 7 months PFS is defined as the time from randomization date until the date of disease progression, or death from any cause
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) 1 year 7 months ORR is defined as the proportion of subjects who have a best overall response of CR or PR according to the Lugano Classification over the entire duration of the study, including the efficacy follow-up period.
Complete Response Rate (CRR) 1 year 7 months CRR is defined as the proportion of subjects who have a best overall response of CR during the study (i.e., up to time of analysis of PFS).
Overall Survival 1 year 7 months OS is defined as the time (in days) from randomization until death from any cause. For subjects alive at the time of analysis, they will be censored at the last documented alive date.
Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab) 1 year 7 months Measured by the number of Treatment Emergent AEs
Number of SAEs (Zandelisib When Combined With Rituximab) 1 year 7 months Measured by the number of SAEs
Number of Lab Abnormalities (Zandelisib When Combined With Rituximab) 1 year 7 months Measured by the number of laboratory abnormalities
Trial Locations
- Locations (138)
Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center
🇺🇸Springfield, Missouri, United States
Community Cancer Trials of Utah
🇺🇸Ogden, Utah, United States
Centre intégré universitaire de santé et de services sociaux de l'Estrie
🇨🇦Sherbrooke, Quebec, Canada
LTD "Medinvest" Institute of Hematology and Transfusiology
🇬🇪Tbilisi, Georgia
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz,
🇭🇺Nyiregyhaza, Hungary
Pratia MCM Krakow
🇵🇱Kraków, Poland
Zvezdara University Medical Center, Clinical department for Hematology and Oncology
🇷🇸Belgrade, Serbia
General Hospital of Athens "Laiko", Department of Haematology and Bone Marrow Transplantation
🇬🇷Athens, Greece
Eastern Regional Health Authority
🇨🇦Saint John's, Newfoundland and Labrador, Canada
Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály
🇭🇺Budapest, Hungary
J.S.C. K. Eristavi National Center of Experimental and Clinic
🇬🇪Tbilisi, Georgia
General Hospital of Thessaloniki "G. Papanikolaou"
🇬🇷Thessaloníki, Greece
Centrum Medyczne Pratia Poznan
🇵🇱Skorzewo, Poland
University Clinical Center of Serbia, Clinic for Hematology
🇷🇸Belgrade, Serbia
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Clinical Center of Vojvodina, Clinic for Hematology
🇷🇸Novi Sad, Serbia
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
The Oncology Institute of Hope and Innovation
🇺🇸Riverside, California, United States
Orange Coast Memorial Medical Center
🇺🇸Fountain Valley, California, United States
CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte,
🇫🇷Clermont-Ferrand, France
AZ Sint-Jan Burgge-Oostende AV
🇧🇪Brugge, Belgium
The Perth Blood Institute (PBI)
🇦🇺West Perth, Australia
UZ Brussel
🇧🇪Brussel, Belgium
Alpha Research Institute, LLC
🇺🇸Baytown, Texas, United States
Westmead Hospital
🇦🇺Westmead, Australia
UZ Leuven Campus Gasthuisberg
🇧🇪Leuven, Belgium
Canberra Hospital
🇦🇺Garran, Australia
LTD Israeli-Georgian Medical Research Clinic "Helsicore"
🇬🇪Tbilisi, Georgia
M. Zodelava Hematology Center
🇬🇪Tbilisi, Georgia
CHU de Bordeaux - Maladies Du Sang, Centre François Magendie
🇫🇷Pessac, France
Centre Hospitalier De Dunkerque - Service d'hématologie
🇫🇷Le Mans, France
CHU de Tours, Hôpital Bretonneau Centre
🇫🇷Tours Cedex 1, France
Centre Hospitalier du Mans
🇫🇷Le Mans, France
University General Hospital of Ioannina, Department of Haematology
🇬🇷Ioánnina, Greece
University General Hospital of Patras "Panagia H. Voitheia"
🇬🇷Patras, Greece
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika
🇭🇺Debrecen, Hungary
UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre
🇮🇹Mestre, Italy
Dipartimento di Oncoematologia, Unità Linfomi, Ospedale
🇮🇹Milano, Italy
Kindai University Hospital
🇯🇵Osakasayama-shi, Osaka, Japan
Aichi Cancer Center Hospital
🇯🇵Nagoya, Japan
Aomori Prefectural Central Hospital
🇯🇵Aomori, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Minami, Fukuoka, Japan
Kagoshima University Hospital
🇯🇵Sakuragaoka, Kagoshima-Shi, Kagoshima, Japan
U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi
🇮🇹Firenze, Italy
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna
🇮🇹Rimini, Italy
Anjo Kosei Hospital
🇯🇵Aichi, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Dunedin Hospital, Southern Blood and Cancer Service
🇳🇿Dunedin, New Zealand
Istituti Fisioterapici Ospitalieri
🇮🇹Roma, Italy
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama-Shi, Ehime, Japan
UO Ematologia, Ospedale Civile S.Maria delle Croci
🇮🇹Ravenna, Italy
Albert Schweizer Ziekenhuis, Hematology Department
🇳🇱Dordrecht, Netherlands
Dong-A university Hospital
🇰🇷Busan, Korea, Republic of
National University Corporation Tohoku University Hospital
🇯🇵Miyagi, Japan
Chonnam National University Hwasun Hospital
🇰🇷Jeollyang, Korea, Republic of
Okayama University Hospital
🇯🇵Okayama, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
🇯🇵Tokyo, Japan
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
🇯🇵Tokyo, Japan
Oncology Institute of Vojvodina, Clinic for Internal Oncology
🇷🇸Kamenica, Serbia
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Hospital Universitario Mútua Terrassa
🇪🇸Barcelona, Spain
Spaarne Gasthuis, Oncology Department
🇳🇱Hoofddorp, Netherlands
Klinika Hematologii, Szpital Uniwersytecki
🇵🇱Bydgoszcz, Poland
Canterbury District Health Board, Haematology Department
🇳🇿Christchurch, New Zealand
Hospital Universitario de Canarias
🇪🇸Santa Cruz De Tenerife, Spain
SOC Oncologia Medica e dei Tumori Immunocorrelati
🇮🇹Aviano, Italy
UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle
🇮🇹Cuneo, Italy
U.O. Clinica Ematologica
🇮🇹Genova, Italy
SC Oncologia Medica
🇮🇹Meldola, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
🇮🇹Milano, Italy
Azienda Ospedaliera Ospedali Riuniti Via Sofia
🇮🇹Palermo, Italy
S.C. Oncoematologia Azienda Ospedaliera Santa Maria
🇮🇹Terni, Italy
McGill University Health Centre
🇨🇦Québec, Canada
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kamigyo-ku, Kyoto, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Hôpital Saint-Louis
🇫🇷Paris, France
Centre Leon Berard
🇫🇷Lyon, France
Centre Henri Becquerel, Service d'Hematologie
🇫🇷Rouen, France
Institut De Cancerologie Gustave Roussy
🇫🇷Villejuif, France
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
BRCR Medical Center Inc
🇺🇸Hollywood, Florida, United States
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
Revive Research Institute
🇺🇸Sterling Heights, Michigan, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Chugoku Central Hospital
🇯🇵Hiroshima, Japan
UOC Ematologia, Presidio Ospedaliero Papardo
🇮🇹Messina, Italy
Divisione Oncoematologia, Istituto Europeo di Oncologia
🇮🇹Milano, Italy
National Hospital Organization Nagoya Medical Center
🇯🇵Naka-ku, Aichi, Japan
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
🇯🇵Aichi, Japan
National Hospital Organization Kumamoto Medical Center
🇯🇵Kumamoto, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Hokkaido University Hospital
🇯🇵Hokkaido, Japan
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Keio University Hospital
🇯🇵Tokyo, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Ewka Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
ARS Medical - Szpital, Oddzial hematologiczny
🇵🇱Piła, Poland
Clinical Hospital Center "Zemun", Clinic for Internal Medicine, Department for Hematology
🇷🇸Belgrade, Serbia
University Clinical Center Kragujevac, Clinic for Hematology
🇷🇸Kragujevac, Serbia
Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology
🇪🇸Barcelona, Spain
Hospital Universitario Quironsalud
🇪🇸Alcorcón, Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Institut Catalá d'Oncologia, Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Complejo Hospitalario de Navarra
🇪🇸Navarro, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
China Medical University Hospital
🇨🇳Taichung, Taiwan
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Chi Mei Hospital
🇨🇳Tainan City, Taiwan
Gazi University Health Research and Application Hospital, Hematology Department
🇹🇷Ankara, Turkey
Istanbul University Istanbul Medical Faculty, Hematology Department
🇹🇷Istanbul, Turkey
Erciyes University Medical Faculty, Department of Hematology
🇹🇷Kayseri, Turkey
Ondokuz Mayis University Medical Faculty, Hematology Department
🇹🇷Samsun, Turkey
Karadeniz Technical University Medical Faculty Department of Hematology
🇹🇷Trabzon, Turkey
North Wales Cancer Treatment Centre
🇬🇧Bodelwyddan, Denbighshire, United Kingdom
Namik Kemal University Hospital
🇹🇷Tekirdağ, Turkey
Royal Cornwall Hospital
🇬🇧Cornwell, United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
🇬🇧Surrey Quays, United Kingdom
Department of Haematology St. George's University of London
🇬🇧London, United Kingdom
Genesis Care Oxford
🇬🇧Oxford, United Kingdom
Imperial College Healthcare NHS Trust Hammersmith Hospital
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
University Hospitals Plymouth NHS Trust, Derriford Hopital
🇬🇧Plymouth, United Kingdom
Valley Cancer Associates
🇺🇸Harlingen, Texas, United States
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Center Hospitalier de Jolimont
🇧🇪Haine-Saint-Paul, Belgium
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Inspira Medical Center Mullica Hill
🇺🇸Mullica Hill, New Jersey, United States