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

Primary Purpose

Follicular Lymphoma (FL), Non Hodgkin Lymphoma, Marginal Zone Lymphoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zandelisib
Rituximab
Bendamustine
CHOP
Sponsored by
MEI Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma (FL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Oncology Institute of Hope and Innovation
  • Orange Coast Memorial Medical Center
  • Long Beach Memorial Medical Center
  • The Oncology Institute of Hope and Innovation
  • BRCR Medical Center Inc
  • Henry Ford Hospital
  • Revive Research Institute
  • Revive Research Institute
  • Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center
  • Inspira Medical Center Mullica Hill
  • MetroHealth Medical Center
  • Alpha Research Institute, LLC
  • Valley Cancer Associates
  • Community Cancer Trials of Utah
  • Canberra Hospital
  • The Perth Blood Institute (PBI)
  • Westmead Hospital
  • AZ Sint-Jan Burgge-Oostende AV
  • UZ Brussel
  • Universitair Ziekenhuis Antwerpen
  • Center Hospitalier de Jolimont
  • UZ Leuven Campus Gasthuisberg
  • Eastern Regional Health Authority
  • Centre intégré universitaire de santé et de services sociaux de l'Estrie
  • McGill University Health Centre
  • CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte,
  • Centre Hospitalier De Dunkerque - Service d'hématologie
  • Centre Hospitalier du Mans
  • Centre Leon Berard
  • Hôpital Saint-Louis
  • CHU de Bordeaux - Maladies Du Sang, Centre François Magendie
  • Centre Henri Becquerel, Service d'Hematologie
  • CHU de Tours, Hôpital Bretonneau Centre
  • Institut De Cancerologie Gustave Roussy
  • LTD Israeli-Georgian Medical Research Clinic "Helsicore"
  • M. Zodelava Hematology Center
  • J.S.C. K. Eristavi National Center of Experimental and Clinic
  • LTD "Medinvest" Institute of Hematology and Transfusiology
  • General Hospital of Athens "Laiko", Department of Haematology and Bone Marrow Transplantation
  • University General Hospital of Ioannina, Department of Haematology
  • University General Hospital of Patras "Panagia H. Voitheia"
  • General Hospital of Thessaloniki "G. Papanikolaou"
  • Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály
  • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz,
  • SOC Oncologia Medica e dei Tumori Immunocorrelati
  • UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi
  • U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle
  • U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi
  • U.O. Clinica Ematologica
  • SC Oncologia Medica
  • UOC Ematologia, Presidio Ospedaliero Papardo
  • UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
  • Dipartimento di Oncoematologia, Unità Linfomi, Ospedale
  • Divisione Oncoematologia, Istituto Europeo di Oncologia
  • Azienda Ospedaliera Ospedali Riuniti Via Sofia
  • UO Ematologia, Ospedale Civile S.Maria delle Croci
  • UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna
  • Istituti Fisioterapici Ospitalieri
  • S.C. Oncoematologia Azienda Ospedaliera Santa Maria
  • National Hospital Organization Nagoya Medical Center
  • National Hospital Organization Shikoku Cancer Center
  • National Hospital Organization Kyushu Cancer Center
  • Gunma University Hospital
  • Kobe City Medical Center General Hospital
  • Kagoshima University Hospital
  • University Hospital Kyoto Prefectural University of Medicine
  • Kindai University Hospital
  • Anjo Kosei Hospital
  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
  • Aomori Prefectural Central Hospital
  • Chiba Cancer Center
  • Kyushu University Hospital
  • Chugoku Central Hospital
  • Hokkaido University Hospital
  • National Hospital Organization Kumamoto Medical Center
  • Kyoto University Hospital
  • National University Corporation Tohoku University Hospital
  • Aichi Cancer Center Hospital
  • Okayama University Hospital
  • Osaka International Cancer Institute
  • Osaka University Hospital
  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research
  • Keio University Hospital
  • Inje University Busan Paik Hospital
  • Dong-A university Hospital
  • Pusan National University Hospital
  • Kyungpook National University Hospital
  • Chonnam National University Hwasun Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • The Catholic University of Korea
  • Ewka Womans University Mokdong Hospital
  • Ulsan University Hospital
  • Albert Schweizer Ziekenhuis, Hematology Department
  • Spaarne Gasthuis, Oncology Department
  • Canterbury District Health Board, Haematology Department
  • Dunedin Hospital, Southern Blood and Cancer Service
  • Klinika Hematologii, Szpital Uniwersytecki
  • Pratia MCM Krakow
  • ARS Medical - Szpital, Oddzial hematologiczny
  • Centrum Medyczne Pratia Poznan
  • University Clinical Center of Serbia, Clinic for Hematology
  • Zvezdara University Medical Center, Clinical department for Hematology and Oncology
  • Clinical Hospital Center "Zemun", Clinic for Internal Medicine, Department for Hematology
  • Oncology Institute of Vojvodina, Clinic for Internal Oncology
  • University Clinical Center Kragujevac, Clinic for Hematology
  • Clinical Center of Vojvodina, Clinic for Hematology
  • Hospital Universitario Quironsalud
  • Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology
  • Hospital Universitario Mútua Terrassa
  • Institut Catalá d'Oncologia, Hospital Duran i Reynals
  • Hospital Universitario Ramón y Cajal
  • Complejo Hospitalario de Navarra
  • Hospital Universitario de Canarias
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Miguel Servet
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • Chi Mei Hospital
  • National Cheng Kung University Hospital
  • Gazi University Health Research and Application Hospital, Hematology Department
  • Istanbul University Istanbul Medical Faculty, Hematology Department
  • Erciyes University Medical Faculty, Department of Hematology
  • Ondokuz Mayis University Medical Faculty, Hematology Department
  • Namik Kemal University Hospital
  • Karadeniz Technical University Medical Faculty Department of Hematology
  • North Wales Cancer Treatment Centre
  • Royal Cornwall Hospital
  • Department of Haematology St. George's University of London
  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
  • Imperial College Healthcare NHS Trust Hammersmith Hospital
  • The Christie NHS Foundation Trust
  • Genesis Care Oxford
  • University Hospitals Plymouth NHS Trust, Derriford Hopital
  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rituximab plus Zandelisib

Rituximab plus chemotherapy

Arm Description

Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles

Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles

Outcomes

Primary Outcome Measures

Progression Free Survival
PFS is defined as the time from randomization date until the date of disease progression, or death from any cause

Secondary Outcome Measures

Overall Response Rate (ORR)
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)
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
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)
Measured by the number of Treatment Emergent AEs
Number of SAEs (Zandelisib when combined with Rituximab)
Measured by the number of SAEs
Number of Lab Abnormalities (Zandelisib when combined with Rituximab)
Measured by the number of laboratory abnormalities

Full Information

First Posted
February 4, 2021
Last Updated
May 5, 2023
Sponsor
MEI Pharma, Inc.
Collaborators
Kyowa Kirin, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04745832
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Discontinuation of zandelisib program
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
March 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MEI Pharma, Inc.
Collaborators
Kyowa Kirin, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma (FL), Non Hodgkin Lymphoma, Marginal Zone Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: Rituximab plus Zandelisib Arm 2: Rituximab plus chemotherapy (CHOP or Bendamustine)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab plus Zandelisib
Arm Type
Experimental
Arm Description
Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles
Arm Title
Rituximab plus chemotherapy
Arm Type
Experimental
Arm Description
Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Zandelisib
Other Intervention Name(s)
ME-401
Intervention Description
Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera
Intervention Description
Rituximab IV 375 mg/m2 for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Bendeka, Treanda, Belrapzo
Intervention Description
Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles
Intervention Type
Drug
Intervention Name(s)
CHOP
Other Intervention Name(s)
cyclophosphamide 750 mg/m2, hydroxydoxorubicin IV 50 mg/m2, vincristine IV 1.4 mg/m2 and prednisone 100 mg daily
Intervention Description
Cyclophosphamide, Vindcristine IV, and Prednisone daily orally
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
PFS is defined as the time from randomization date until the date of disease progression, or death from any cause
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
5 years
Title
Complete Response Rate (CRR)
Description
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).
Time Frame
5 years
Title
Overall Survival
Description
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.
Time Frame
10 years
Title
Number of Treatment Emergent AEs (Zandelisib when combined with Rituximab)
Description
Measured by the number of Treatment Emergent AEs
Time Frame
5 years
Title
Number of SAEs (Zandelisib when combined with Rituximab)
Description
Measured by the number of SAEs
Time Frame
5 years
Title
Number of Lab Abnormalities (Zandelisib when combined with Rituximab)
Description
Measured by the number of laboratory abnormalities
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Oncology Institute of Hope and Innovation
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Orange Coast Memorial Medical Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
BRCR Medical Center Inc
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Revive Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Revive Research Institute
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Inspira Medical Center Mullica Hill
City
Mullica Hill
State/Province
New Jersey
ZIP/Postal Code
08062
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Alpha Research Institute, LLC
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Valley Cancer Associates
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Community Cancer Trials of Utah
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Canberra Hospital
City
Garran
ZIP/Postal Code
2605
Country
Australia
Facility Name
The Perth Blood Institute (PBI)
City
West Perth
ZIP/Postal Code
6005
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
AZ Sint-Jan Burgge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
655, 2650
Country
Belgium
Facility Name
Center Hospitalier de Jolimont
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
UZ Leuven Campus Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Eastern Regional Health Authority
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B3V6
Country
Canada
Facility Name
Centre intégré universitaire de santé et de services sociaux de l'Estrie
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
JIH5N4
Country
Canada
Facility Name
McGill University Health Centre
City
Québec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte,
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Hospitalier De Dunkerque - Service d'hématologie
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Hospitalier du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU de Bordeaux - Maladies Du Sang, Centre François Magendie
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Centre Henri Becquerel, Service d'Hematologie
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
CHU de Tours, Hôpital Bretonneau Centre
City
Tours Cedex 1
ZIP/Postal Code
37044
Country
France
Facility Name
Institut De Cancerologie Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
LTD Israeli-Georgian Medical Research Clinic "Helsicore"
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
M. Zodelava Hematology Center
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
J.S.C. K. Eristavi National Center of Experimental and Clinic
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
LTD "Medinvest" Institute of Hematology and Transfusiology
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
General Hospital of Athens "Laiko", Department of Haematology and Bone Marrow Transplantation
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Ioannina, Department of Haematology
City
Ioánnina
ZIP/Postal Code
455 00
Country
Greece
Facility Name
University General Hospital of Patras "Panagia H. Voitheia"
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
General Hospital of Thessaloniki "G. Papanikolaou"
City
Thessaloníki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály
City
Budapest
ZIP/Postal Code
H-1122
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz,
City
Nyiregyhaza
ZIP/Postal Code
H-4400
Country
Hungary
Facility Name
SOC Oncologia Medica e dei Tumori Immunocorrelati
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
U.O. Clinica Ematologica
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
SC Oncologia Medica
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
UOC Ematologia, Presidio Ospedaliero Papardo
City
Messina
ZIP/Postal Code
98158
Country
Italy
Facility Name
UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre
City
Mestre
ZIP/Postal Code
30174
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Dipartimento di Oncoematologia, Unità Linfomi, Ospedale
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Divisione Oncoematologia, Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Via Sofia
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
UO Ematologia, Ospedale Civile S.Maria delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Istituti Fisioterapici Ospitalieri
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
S.C. Oncoematologia Azienda Ospedaliera Santa Maria
City
Terni
ZIP/Postal Code
05110
Country
Italy
Facility Name
National Hospital Organization Nagoya Medical Center
City
Naka-ku
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama-Shi
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Minami
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kagoshima University Hospital
City
Sakuragaoka
State/Province
Kagoshima-Shi, Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kamigyo-ku
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Anjo Kosei Hospital
City
Aichi
ZIP/Postal Code
446-8602
Country
Japan
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
City
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Aomori Prefectural Central Hospital
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Chugoku Central Hospital
City
Hiroshima
ZIP/Postal Code
720-0001
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
National University Corporation Tohoku University Hospital
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Dong-A university Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollyang
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Ewka Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Albert Schweizer Ziekenhuis, Hematology Department
City
Dordrecht
ZIP/Postal Code
3318
Country
Netherlands
Facility Name
Spaarne Gasthuis, Oncology Department
City
Hoofddorp
ZIP/Postal Code
2134
Country
Netherlands
Facility Name
Canterbury District Health Board, Haematology Department
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Hospital, Southern Blood and Cancer Service
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Klinika Hematologii, Szpital Uniwersytecki
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Pratia MCM Krakow
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
ARS Medical - Szpital, Oddzial hematologiczny
City
Piła
ZIP/Postal Code
64-920
Country
Poland
Facility Name
Centrum Medyczne Pratia Poznan
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
University Clinical Center of Serbia, Clinic for Hematology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Zvezdara University Medical Center, Clinical department for Hematology and Oncology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center "Zemun", Clinic for Internal Medicine, Department for Hematology
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Oncology Institute of Vojvodina, Clinic for Internal Oncology
City
Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
University Clinical Center Kragujevac, Clinic for Hematology
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center of Vojvodina, Clinic for Hematology
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Hospital Universitario Quironsalud
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Mútua Terrassa
City
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Institut Catalá d'Oncologia, Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Navarro
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404332
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Chi Mei Hospital
City
Tainan City
ZIP/Postal Code
73657
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Gazi University Health Research and Application Hospital, Hematology Department
City
Ankara
ZIP/Postal Code
29 06560
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty, Hematology Department
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Erciyes University Medical Faculty, Department of Hematology
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Ondokuz Mayis University Medical Faculty, Hematology Department
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Namik Kemal University Hospital
City
Tekirdağ
ZIP/Postal Code
59100
Country
Turkey
Facility Name
Karadeniz Technical University Medical Faculty Department of Hematology
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
North Wales Cancer Treatment Centre
City
Bodelwyddan
State/Province
Denbighshire
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Cornwell
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Department of Haematology St. George's University of London
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Genesis Care Oxford
City
Oxford
ZIP/Postal Code
OX4 6LB
Country
United Kingdom
Facility Name
University Hospitals Plymouth NHS Trust, Derriford Hopital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
City
Surrey Quays
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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