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Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zandelisib (ME-401)
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:

  • Histologically confirmed diagnosis as defined in the World Health Organization (WHO) classification scheme

    1. Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or
    2. Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL
  • Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL or MZL
  • Age ≥ 18
  • At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification
  • Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment
  • QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec);
  • Left ventricular ejection fraction (LVEF) ≥ 45%

Exclusion Criteria:

  • Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma
  • Known lymphomatous involvement of the central nervous system
  • Uncontrolled clinically significant illness
  • Ongoing or history of drug-induced pneumonitis
  • History of clinically significant cardiovascular abnormalities
  • History of clinically significant GI conditions
  • Known history of, or active HIV infection

Sites / Locations

  • Oncology Institute of Hope and Innovation
  • Pacific Cancer Medical Center, Inc.
  • Tower Hematology Oncology
  • The Oncology Institute of Hope and Innovation
  • Sharp Memorial Hospital
  • H. Lee Moffit Cancer Center
  • Cleveland Clinic-Florida
  • Rush University Medical Center
  • Advocate Health & Hospitals Corporation
  • Investigative Clinical Research of Indiana LLC
  • Dana-Farber Cancer Institute
  • University of Michigan Medical School
  • St. Vincent Frontier Cancer Center
  • The Oncology Institute of Hope and Innovation
  • Memorial Sloan Kettering
  • Memorial Sloan Kettering
  • Memorial Sloan Kettering
  • San Juan Oncology
  • Memorial Sloan Kettering
  • Memorial Sloan Kettering
  • Clinical Research Alliance
  • Memorial Sloan Kettering
  • Stony Brook University
  • Memorial Sloan Kettering
  • Duke Cancer Center
  • Cleveland Clinic
  • Oregon Health and Science University
  • Vanderbilt University
  • Renovatio Clinical
  • Swedish Cancer Institute
  • Swedish Cancer Institute
  • Medical Oncology Associates PS
  • University of Wisconsin Carbone Cancer Center
  • Marshfield Medical Center
  • Peninsula and South Eastern Haematology and Oncology Group
  • The Perth Blood Institute
  • Liverpool Hospital
  • Kepler Universitatsklinikum GmBH
  • Medical University of Vienna
  • AZ Sint-Jan Brugge-Oostende
  • Institut Jules Bordet
  • Cliniques Universitaires Saint-Luc
  • Antwerp University Hospital
  • C H de la Cote Basque, Service d'Hematologie
  • CHD Vendee, Onco-hematologie
  • Centre Hospitalier du Mans
  • Centre Hospitalier de Mulhouse
  • Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie
  • Institut Gustave Roussy
  • Klinikum Mutterhaus Feldstr
  • Hamatologisch-Onkolgische Praxis
  • Universitatsklinikum Halle
  • Munich Municipal Hospital
  • Universitatsklinikum Munster
  • Universitatsklinikum Ulm
  • Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
  • Policlinico Sant'Orsola Malpighi
  • IRCCS AOU Policlinico San Martino
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.
  • UOC Oncoematologia
  • Ospedale Santa Maria delle Croci
  • Infermi Hospital Rimini
  • Universita Cattolica del Sacro Cuore
  • IRCCS Regina Elena National Cancer Institute
  • Azienda Ospedaliera Santa Maria
  • Ospedale DellAngelo Di Mestre Umberto I
  • Dong-A University Hospital
  • Pusan National University Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Ewha Womans University Mokdong Hospital
  • The Catholic University of Korea-Seoul St. Marys Hospital
  • Ulsan University Hospital
  • North Shore Hospital
  • Southern District Hospital
  • Szpital Uniwersytecki nr 2 im.
  • Pratia MCM Krakow
  • Primary Specialty Oncology
  • Instytut Hematologii i Transfuzjologii
  • Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
  • ojewodzkie Wielospecjalistyczne Centrum
  • Hospital Universitario de Canarias
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitari Mutua Terrasa
  • ICO-Hospital Duran i Reynals
  • MD Anderson Cancer Center
  • Hospital Universitario Ramon y Cajal
  • Fundacion Jimenez Diaz
  • Hospital Universitario Quiron Salud Madrid
  • Complejo Hospitalario de Navarra
  • Hospital Clinico de Salamanca
  • Hospital Universitario Virgen Macarena
  • Hospital Virgen del Rocio
  • Miguel Servet Hospital
  • Ente Ospedaliero Cantonale (EOC)
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • Chi-Mei Medical Center, Liouying
  • National Taiwan University Hospital NTUH
  • North Wales Cancer Treatment Centre, Glan Clwyd Hospital
  • Royal Marsden Hospital
  • Nottingham University Hospital
  • Belfast Health and Social Care Trust - Belfast City Hospital
  • Royal Cornwall Hospital
  • e Clatterbridge Cancer Centre
  • Royal Liverpool University Hospital
  • Lewisham and Greenwich University Hospital Lewisham
  • St George's Hospital
  • Centre for Haematology, Imperial College London
  • The Christie NHS Foundation Trust
  • Norfolk and Norwich University Hospital NHS Foundation Trust
  • Oxford University Hospitals
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zandelisib (ME-401) open label

Arm Description

Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).

Outcomes

Primary Outcome Measures

Objective response rate (ORR) of ME-401 in relapsed or refractory FL or MZL based on the Independent Review Committee assessment
ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD

Secondary Outcome Measures

Duration of response (DOR)
Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression
Complete response (CR) rate
Complete response rate will be measured by the number of subjects that achieve CR
Progression-free survival (PFS)
Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death
Overall Survival
Overall survival will be measured as the time from initiation of treatment (Day 1) until death
Overall incidence of treatment emergent adverse events (TEAEs)
The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE.
PK of ME-401
The PK of ME-401 will be determined by the peak plasma concentration (Cmax)

Full Information

First Posted
December 4, 2018
Last Updated
May 5, 2023
Sponsor
MEI Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03768505
Brief Title
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
Official Title
A Multicenter, Open Label Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects With Follicular Lymphoma and Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies (The TIDAL 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
June 25, 2019 (Actual)
Primary Completion Date
March 24, 2023 (Actual)
Study Completion Date
March 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MEI Pharma, 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 the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy
Detailed Description
This is a global, multicenter open-label, single-arm, Phase 2 study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy which must have included an anti-CD20 antibody and chemotherapy with an alkylating agent or a purine analogue. Approximately 180 subjects will be enrolled and treated with Zandelisib (ME-401) on the intermittent schedule.

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 2
Interventional Study Model
Single Group Assignment
Model Description
Treatment with Zandelisib (ME-401) (60 mg) given orally once a day on an intermittent schedule
Masking
None (Open Label)
Allocation
N/A
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zandelisib (ME-401) open label
Arm Type
Experimental
Arm Description
Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
Intervention Type
Drug
Intervention Name(s)
Zandelisib (ME-401)
Intervention Description
Zandelisib (ME-401) 60 mg
Primary Outcome Measure Information:
Title
Objective response rate (ORR) of ME-401 in relapsed or refractory FL or MZL based on the Independent Review Committee assessment
Description
ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Duration of response (DOR)
Description
Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression
Time Frame
2 years
Title
Complete response (CR) rate
Description
Complete response rate will be measured by the number of subjects that achieve CR
Time Frame
2 years
Title
Progression-free survival (PFS)
Description
Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death
Time Frame
2 years
Title
Overall Survival
Description
Overall survival will be measured as the time from initiation of treatment (Day 1) until death
Time Frame
2 years
Title
Overall incidence of treatment emergent adverse events (TEAEs)
Description
The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE.
Time Frame
2 years
Title
PK of ME-401
Description
The PK of ME-401 will be determined by the peak plasma concentration (Cmax)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis as defined in the World Health Organization (WHO) classification scheme Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL or MZL Age ≥ 18 At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec); Left ventricular ejection fraction (LVEF) ≥ 45% Exclusion Criteria: Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma Known lymphomatous involvement of the central nervous system Uncontrolled clinically significant illness Ongoing or history of drug-induced pneumonitis History of clinically significant cardiovascular abnormalities History of clinically significant GI conditions Known history of, or active HIV infection
Facility Information:
Facility Name
Oncology Institute of Hope and Innovation
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Pacific Cancer Medical Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Tower Hematology Oncology
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
H. Lee Moffit Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Cleveland Clinic-Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
333331
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Advocate Health & Hospitals Corporation
City
Niles
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Investigative Clinical Research of Indiana LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Medical School
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Memorial Sloan Kettering
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
San Juan Oncology
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
Memorial Sloan Kettering
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Clinical Research Alliance
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Memorial Sloan Kettering
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Renovatio Clinical
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Swedish Cancer Institute
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Medical Oncology Associates PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Marshfield Medical Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Peninsula and South Eastern Haematology and Oncology Group
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
The Perth Blood Institute
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Facility Name
Liverpool Hospital
City
Sydney
ZIP/Postal Code
NSW2170
Country
Australia
Facility Name
Kepler Universitatsklinikum GmBH
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
AZ Sint-Jan Brugge-Oostende
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
C H de la Cote Basque, Service d'Hematologie
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
CHD Vendee, Onco-hematologie
City
La Roche-Sur-Yon Cedex 9
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Hospitalier du Mans
City
Le Mans
ZIP/Postal Code
F720000
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Klinikum Mutterhaus Feldstr
City
Trier
State/Province
Rheinland-Pfalz
Country
Germany
Facility Name
Hamatologisch-Onkolgische Praxis
City
Nordheim
State/Province
Stolberg
ZIP/Postal Code
52222
Country
Germany
Facility Name
Universitatsklinikum Halle
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Munich Municipal Hospital
City
Munich
ZIP/Postal Code
80804
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
IRCCS AOU Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
UOC Oncoematologia
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Santa Maria delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Infermi Hospital Rimini
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Universita Cattolica del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
IRCCS Regina Elena National Cancer Institute
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Ospedale DellAngelo Di Mestre Umberto I
City
Venice
ZIP/Postal Code
30174
Country
Italy
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
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
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
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Facility Name
The Catholic University of Korea-Seoul St. Marys Hospital
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
North Shore Hospital
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Southern District Hospital
City
Dunedin
ZIP/Postal Code
9054
Country
New Zealand
Facility Name
Szpital Uniwersytecki nr 2 im.
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
Primary Specialty Oncology
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
City
Wroclaw
ZIP/Postal Code
53-439
Country
Poland
Facility Name
ojewodzkie Wielospecjalistyczne Centrum
City
Łódź
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari Mutua Terrasa
City
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
ICO-Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Quiron Salud Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clinico de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Miguel Servet Hospital
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Ente Ospedaliero Cantonale (EOC)
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Chi-Mei Medical Center, Liouying
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Facility Name
National Taiwan University Hospital NTUH
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
City
Rhyl
State/Province
Denbighire
ZIP/Postal Code
LL185UJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
State/Province
Sutton
ZIP/Postal Code
SM25PT
Country
United Kingdom
Facility Name
Nottingham University Hospital
City
Nottingham
State/Province
UK
ZIP/Postal Code
NG51PB
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust - Belfast City Hospital
City
Belfast
ZIP/Postal Code
28040
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Cornwell
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
e Clatterbridge Cancer Centre
City
Liverpool
ZIP/Postal Code
L78XP
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L78XP
Country
United Kingdom
Facility Name
Lewisham and Greenwich University Hospital Lewisham
City
London
ZIP/Postal Code
SE136LH
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW170QT
Country
United Kingdom
Facility Name
Centre for Haematology, Imperial College London
City
London
ZIP/Postal Code
W12ONN
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital NHS Foundation Trust
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Oxford University Hospitals
City
Oxford
ZIP/Postal Code
0X46LB
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S102JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)

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