Clinical trial NCT04745832: Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
Official title: A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Follicular Lymphoma (FL)
Non Hodgkin Lymphoma
Marginal Zone Lymphoma
Lead sponsor: MEI Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin, Inc.
First posted: 2021-02-09
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Rituximab plus Zandelisib

Arm 2: Rituximab plus chemotherapy (CHOP or Bendamustine)
Primary purpose: TREATMENT

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.

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:

  1. FL Gr 1, Gr 2, or Gr 3a
  2. 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 1 year 7 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 1 year 7 months
measure: Complete Response Rate (CRR)
timeFrame: 1 year 7 months
measure: Overall Survival
timeFrame: 1 year 7 months
measure: Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab)
timeFrame: 1 year 7 months
measure: Number of SAEs (Zandelisib When Combined With Rituximab)
timeFrame: 1 year 7 months
measure: Number of Lab Abnormalities (Zandelisib When Combined With Rituximab)
timeFrame: 1 year 7 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The Oncology Institute of Hope and Innovation
state: Arizona
city: Fountain Valley
country: United States
facility: Orange Coast Memorial Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Riverside
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Hollywood
country: United States
facility: BRCR Medical Center Inc
state: Florida
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Farmington Hills
country: United States
facility: Revive Research Institute
state: Michigan
city: Sterling Heights
country: United States
facility: Revive Research Institute
state: Michigan
city: Springfield
country: United States
facility: Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center
state: Missouri
city: Mullica Hill
country: United States
facility: Inspira Medical Center Mullica Hill
state: New Jersey
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Baytown
country: United States
facility: Alpha Research Institute, LLC
state: Texas
city: Harlingen
country: United States
facility: Valley Cancer Associates
state: Texas
city: Ogden
country: United States
facility: Community Cancer Trials of Utah
state: Utah
city: Garran
country: Australia
facility: Canberra Hospital
city: West Perth
country: Australia
facility: The Perth Blood Institute (PBI)
city: Westmead
country: Australia
facility: Westmead Hospital
city: Brugge
country: Belgium
facility: AZ Sint-Jan Burgge-Oostende AV
city: Brussel
country: Belgium
facility: UZ Brussel
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Haine-Saint-Paul
country: Belgium
facility: Center Hospitalier de Jolimont
city: Leuven
country: Belgium
facility: UZ Leuven Campus Gasthuisberg
city: Saint John's
country: Canada
facility: Eastern Regional Health Authority
state: Newfoundland and Labrador
city: Sherbrooke
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie
state: Quebec
city: Québec
country: Canada
facility: McGill University Health Centre
city: Clermont-Ferrand
country: France
facility: CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte,
city: Le Mans
country: France
facility: Centre Hospitalier De Dunkerque - Service d'hématologie
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lyon
country: France
facility: Centre Leon Berard
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Pessac
country: France
facility: CHU de Bordeaux - Maladies Du Sang, Centre François Magendie
city: Rouen
country: France
facility: Centre Henri Becquerel, Service d'Hematologie
city: Tours Cedex 1
country: France
facility: CHU de Tours, Hôpital Bretonneau Centre
city: Villejuif
country: France
facility: Institut De Cancerologie Gustave Roussy
city: Tbilisi
country: Georgia
facility: LTD Israeli-Georgian Medical Research Clinic "Helsicore"
city: Tbilisi
country: Georgia
facility: M. Zodelava Hematology Center
city: Tbilisi
country: Georgia
facility: J.S.C. K. Eristavi National Center of Experimental and Clinic
city: Tbilisi
country: Georgia
facility: LTD "Medinvest" Institute of Hematology and Transfusiology
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko", Department of Haematology and Bone Marrow Transplantation
city: Ioánnina
country: Greece
facility: University General Hospital of Ioannina, Department of Haematology
city: Patras
country: Greece
facility: University General Hospital of Patras "Panagia H. Voitheia"
city: Thessaloníki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou"
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz,
city: Aviano
country: Italy
facility: SOC Oncologia Medica e dei Tumori Immunocorrelati
city: Bologna
country: Italy
facility: UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi
city: Cuneo
country: Italy
facility: U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle
city: Firenze
country: Italy
facility: U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi
city: Genova
country: Italy
facility: U.O. Clinica Ematologica
city: Meldola
country: Italy
facility: SC Oncologia Medica
city: Messina
country: Italy
facility: UOC Ematologia, Presidio Ospedaliero Papardo
city: Mestre
country: Italy
facility: UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
city: Milano
country: Italy
facility: Dipartimento di Oncoematologia, Unità Linfomi, Ospedale
city: Milano
country: Italy
facility: Divisione Oncoematologia, Istituto Europeo di Oncologia
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Via Sofia
city: Ravenna
country: Italy
facility: UO Ematologia, Ospedale Civile S.Maria delle Croci
city: Rimini
country: Italy
facility: UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna
city: Roma
country: Italy
facility: Istituti Fisioterapici Ospitalieri
city: Terni
country: Italy
facility: S.C. Oncoematologia Azienda Ospedaliera Santa Maria
city: Naka-ku
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Matsuyama-Shi
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Minami
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Sakuragaoka
country: Japan
facility: Kagoshima University Hospital
state: Kagoshima-Shi, Kagoshima
city: Kamigyo-ku
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Aichi
country: Japan
facility: Anjo Kosei Hospital
city: Aichi
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
city: Aomori
country: Japan
facility: Aomori Prefectural Central Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hiroshima
country: Japan
facility: Chugoku Central Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Miyagi
country: Japan
facility: National University Corporation Tohoku University Hospital
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A university Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Jeollyang
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Ewka Womans University Mokdong Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Dordrecht
country: Netherlands
facility: Albert Schweizer Ziekenhuis, Hematology Department
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis, Oncology Department
city: Christchurch
country: New Zealand
facility: Canterbury District Health Board, Haematology Department
city: Dunedin
country: New Zealand
facility: Dunedin Hospital, Southern Blood and Cancer Service
city: Bydgoszcz
country: Poland
facility: Klinika Hematologii, Szpital Uniwersytecki
city: Kraków
country: Poland
facility: Pratia MCM Krakow
city: Piła
country: Poland
facility: ARS Medical - Szpital, Oddzial hematologiczny
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia, Clinic for Hematology
city: Belgrade
country: Serbia
facility: Zvezdara University Medical Center, Clinical department for Hematology and Oncology
city: Belgrade
country: Serbia
facility: Clinical Hospital Center "Zemun", Clinic for Internal Medicine, Department for Hematology
city: Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina, Clinic for Internal Oncology
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac, Clinic for Hematology
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina, Clinic for Hematology
city: Alcorcón
country: Spain
facility: Hospital Universitario Quironsalud
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology
city: Barcelona
country: Spain
facility: Hospital Universitario Mútua Terrassa
city: Barcelona
country: Spain
facility: Institut Catalá d'Oncologia, Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Navarro
country: Spain
facility: Complejo Hospitalario de Navarra
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Ankara
country: Turkey
facility: Gazi University Health Research and Application Hospital, Hematology Department
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty, Hematology Department
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty, Department of Hematology
city: Samsun
country: Turkey
facility: Ondokuz Mayis University Medical Faculty, Hematology Department
city: Tekirdağ
country: Turkey
facility: Namik Kemal University Hospital
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Medical Faculty Department of Hematology
city: Bodelwyddan
country: United Kingdom
facility: North Wales Cancer Treatment Centre
state: Denbighshire
city: Cornwell
country: United Kingdom
facility: Royal Cornwall Hospital
city: London
country: United Kingdom
facility: Department of Haematology St. George's University of London
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Genesis Care Oxford
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust, Derriford Hopital
city: Surrey Quays
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
Study officials:
References: