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

PHASE3TerminatedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

August 13, 2021

Primary Completion Date

March 20, 2023

Study Completion Date

March 20, 2023

Conditions
Follicular Lymphoma (FL)Non Hodgkin LymphomaMarginal Zone Lymphoma
Interventions
DRUG

Zandelisib

Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3

DRUG

Rituximab

Rituximab IV 375 mg/m2 for 6 cycles

DRUG

Bendamustine

Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles

DRUG

CHOP

Cyclophosphamide, Vindcristine IV, and Prednisone daily orally

Trial Locations (141)

704

National Cheng Kung University Hospital, Tainan City

1090

UZ Brussel, Brussels

2134

Spaarne Gasthuis, Oncology Department, Hoofddorp

2145

Westmead Hospital, Westmead

2605

Canberra Hospital, Garran

3318

Albert Schweizer Ziekenhuis, Hematology Department, Dordrecht

6005

The Perth Blood Institute (PBI), West Perth

7100

Center Hospitalier de Jolimont, Haine-Saint-Paul

8000

AZ Sint-Jan Burgge-Oostende AV, Bruges

8011

Canterbury District Health Board, Haematology Department, Christchurch

9016

Dunedin Hospital, Southern Blood and Cancer Service, Dunedin

11000

University Clinical Center of Serbia, Clinic for Hematology, Belgrade

Zvezdara University Medical Center, Clinical department for Hematology and Oncology, Belgrade

11080

"Clinical Hospital Center Zemun, Clinic for Internal Medicine, Department for Hematology", Belgrade

11527

"General Hospital of Athens Laiko, Department of Haematology and Bone Marrow Transplantation", Athens

12100

U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle, Cuneo

16132

U.O. Clinica Ematologica, Genova

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan

20132

Dipartimento di Oncoematologia, Unità Linfomi, Ospedale, Milan

20141

Divisione Oncoematologia, Istituto Europeo di Oncologia, Milan

21000

Clinical Center of Vojvodina, Clinic for Hematology, Novi Sad

21204

Oncology Institute of Vojvodina, Clinic for Internal Oncology, Kamenica

26504

"University General Hospital of Patras Panagia H. Voitheia", Pátrai

28034

Hospital Universitario Ramón y Cajal, Madrid

28223

Hospital Universitario Quironsalud, Alcorcón

30174

UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre, Mestre

31008

Complejo Hospitalario de Navarra, Navarro

33021

BRCR Medical Center Inc, Hollywood

33081

SOC Oncologia Medica e dei Tumori Immunocorrelati, Aviano

33600

CHU de Bordeaux - Maladies Du Sang, Centre François Magendie, Pessac

34000

University Clinical Center Kragujevac, Clinic for Hematology, Kragujevac

34093

Istanbul University Istanbul Medical Faculty, Hematology Department, Istanbul

37044

CHU de Tours, Hôpital Bretonneau Centre, Tours

38039

Erciyes University Medical Faculty, Department of Hematology, Kayseri

38320

Hospital Universitario de Canarias, Santa Cruz de Tenerife

40138

"UO di Ematologia L.e A.Seragnoli Policlinico Sant'Orsola Malpighi", Bologna

40705

Taichung Veterans General Hospital, Taichung

41009

Hospital Universitario Virgen Macarena, Seville

41944

Kyungpook National University Hospital, Daegu

44033

Ulsan University Hospital, Ulsan

44109

MetroHealth Medical Center, Cleveland

47014

SC Oncologia Medica, Meldola

47392

Inje University Busan Paik Hospital, Busan

47923

UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna, Rimini

48121

UO Ematologia, Ospedale Civile S.Maria delle Croci, Ravenna

48202

Henry Ford Hospital, Detroit

48314

Revive Research Institute, Sterling Heights

48334

Revive Research Institute, Farmington Hills

49201

Dong-A university Hospital, Busan

49241

Pusan National University Hospital, Busan

50009

Hospital Universitario Miguel Servet, Zaragoza

50134

U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi, Florence

55200

Ondokuz Mayis University Medical Faculty, Hematology Department, Samsun

57010

"General Hospital of Thessaloniki G. Papanikolaou", Thessaloniki

58128

Chonnam National University Hwasun Hospital, Jeollyang

59100

Namik Kemal University Hospital, Tekirdağ

61080

Karadeniz Technical University Medical Faculty Department of Hematology, Trabzon

63003

CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte,, Clermont-Ferrand

65804

Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center, Springfield

69373

Centre Leon Berard, Lyon

72000

Centre Hospitalier De Dunkerque - Service d'hématologie, Le Mans

Centre Hospitalier du Mans, Le Mans

73657

Chi Mei Hospital, Tainan City

75010

Hôpital Saint-Louis, Paris

76038

Centre Henri Becquerel, Service d'Hematologie, Rouen

77521

Alpha Research Institute, LLC, Baytown

78550

Valley Cancer Associates, Harlingen

84405

Community Cancer Trials of Utah, Ogden

85745

The Oncology Institute of Hope and Innovation, Tucson

90146

Azienda Ospedaliera Ospedali Riuniti Via Sofia, Palermo

90806

Long Beach Memorial Medical Center, Long Beach

92506

The Oncology Institute of Hope and Innovation, Riverside

92708

Orange Coast Memorial Medical Center, Fountain Valley

94805

Institut De Cancerologie Gustave Roussy, Villejuif

98158

UOC Ematologia, Presidio Ospedaliero Papardo, Messina

404332

China Medical University Hospital, Taichung

08062

Inspira Medical Center Mullica Hill, Mullica Hill

655, 2650

Universitair Ziekenhuis Antwerpen, Edegem

Unknown

UZ Leuven Campus Gasthuisberg, Leuven

A1B3V6

Eastern Regional Health Authority, St. John's

JIH5N4

Centre intégré universitaire de santé et de services sociaux de l'Estrie, Sherbrooke

H4A 3J1

McGill University Health Centre, Québec

0112

"LTD Israeli-Georgian Medical Research Clinic Helsicore", Tbilisi

M. Zodelava Hematology Center, Tbilisi

0159

J.S.C. K. Eristavi National Center of Experimental and Clinic, Tbilisi

0186

"LTD Medinvest Institute of Hematology and Transfusiology", Tbilisi

455 00

University General Hospital of Ioannina, Department of Haematology, Ioannina

H-1122

Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály, Budapest

H-4032

Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Debrecen

H-4400

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz,, Nyíregyháza

00144

Istituti Fisioterapici Ospitalieri, Roma

05110

S.C. Oncoematologia Azienda Ospedaliera Santa Maria, Terni

460-0001

National Hospital Organization Nagoya Medical Center, Naka-ku

791-0280

National Hospital Organization Shikoku Cancer Center, Matsuyama

811-1395

National Hospital Organization Kyushu Cancer Center, Minami

371-8511

Gunma University Hospital, Maebashi

650-0047

Kobe City Medical Center General Hospital, Kobe

890-8520

Kagoshima University Hospital, Sakuragaoka

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kamigyō-ku

589-8511

Kindai University Hospital, Osakasayama-shi

446-8602

Anjo Kosei Hospital, Aichi

466-8650

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Aichi

030-8553

Aomori Prefectural Central Hospital, Aomori

260-8717

Chiba Cancer Center, Chiba

812-8582

Kyushu University Hospital, Fukuoka

720-0001

Chugoku Central Hospital, Hiroshima

060-8648

Hokkaido University Hospital, Hokkaido

860-0008

National Hospital Organization Kumamoto Medical Center, Kumamoto

606-8507

Kyoto University Hospital, Kyoto

980-8574

National University Corporation Tohoku University Hospital, Miyagi

464-8681

Aichi Cancer Center Hospital, Nagoya

700-8558

Okayama University Hospital, Okayama

541-8567

Osaka International Cancer Institute, Osaka

565-0871

Osaka University Hospital, Osaka

113-8677

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo

135-8550

The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Tokyo

160-8582

Keio University Hospital, Tokyo

85-168

Klinika Hematologii, Szpital Uniwersytecki, Bydgoszcz

30-510

Pratia MCM Krakow, Krakow

64-920

ARS Medical - Szpital, Oddzial hematologiczny, Piła

60-185

Centrum Medyczne Pratia Poznan, Skorzewo

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea, Seoul

07985

Ewka Womans University Mokdong Hospital, Seoul

08035

Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology, Barcelona

08221

Hospital Universitario Mútua Terrassa, Barcelona

08908

Institut Catalá d'Oncologia, Hospital Duran i Reynals, Barcelona

29 06560

Gazi University Health Research and Application Hospital, Hematology Department, Ankara

LL18 5UJ

North Wales Cancer Treatment Centre, Bodelwyddan

TR1 3LJ

Royal Cornwall Hospital, Cornwell

SW17 0RE

Department of Haematology St. George's University of London, London

SW3 6JJ

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital, London

W12 0HS

Imperial College Healthcare NHS Trust Hammersmith Hospital, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

OX4 6LB

Genesis Care Oxford, Oxford

PL6 8DH

University Hospitals Plymouth NHS Trust, Derriford Hopital, Plymouth

SM2 5PT

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital, Surrey Quays

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Kyowa Kirin, Inc.

INDUSTRY

lead

MEI Pharma, Inc.

INDUSTRY