Study Stopped
discontinuation of zandelisib program
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
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)
2 other identifiers
interventional
169
13 countries
112
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2019
Typical duration for phase_2
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2018
CompletedFirst Posted
Study publicly available on registry
December 7, 2018
CompletedStudy Start
First participant enrolled
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2023
CompletedResults Posted
Study results publicly available
February 1, 2024
CompletedDecember 31, 2024
December 1, 2022
3.7 years
December 4, 2018
December 5, 2023
December 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL
ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD
3 years 9 months
Secondary Outcomes (6)
Duration of Response (DOR)
3 years 9 months
Complete Response (CR) Rate
3 years 9 months
Progression-free Survival (PFS)
3 years 9 months
Overall Survival
2 years
Overall Incidence of Treatment Emergent Adverse Events (TEAEs)
3 years 9 months
- +1 more secondary outcomes
Study Arms (1)
Zandelisib (ME-401) open label
EXPERIMENTALSubjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MEI Pharma, Inc.lead
Study Sites (115)
Oncology Institute of Hope and Innovation
Tucson, Arizona, 85710, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
Tower Hematology Oncology
Beverly Hills, California, 90211, United States
The Oncology Institute of Hope and Innovation
Downey, California, 90241, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
H. Lee Moffit Cancer Center
Tampa, Florida, 33612, United States
Cleveland Clinic-Florida
Weston, Florida, 333331, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Advocate Health & Hospitals Corporation
Niles, Illinois, 61761, United States
Investigative Clinical Research of Indiana LLC
Indianapolis, Indiana, 46260, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Medical School
Ann Arbor, Michigan, 48109, United States
St. Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
The Oncology Institute of Hope and Innovation
Henderson, Nevada, 89052, United States
Memorial Sloan Kettering
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering
Montvale, New Jersey, 07645, United States
San Juan Oncology
Farmington, New Mexico, 87401, United States
Memorial Sloan Kettering
Commack, New York, 11725, United States
Memorial Sloan Kettering
Harrison, New York, 10604, United States
Clinical Research Alliance
Lake Success, New York, 11042, United States
Memorial Sloan Kettering
New York, New York, 10065, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Memorial Sloan Kettering
Uniondale, New York, 11553, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Vanderbilt University
Nashville, Tennessee, 37203, United States
Renovatio Clinical
Houston, Texas, 77056, United States
Swedish Cancer Institute
Edmonds, Washington, 98026, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Medical Oncology Associates PS
Spokane, Washington, 99208, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705, United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199, Australia
The Perth Blood Institute
West Perth, Western Australia, 6005, Australia
Liverpool Hospital
Sydney, NSW2170, Australia
Kepler Universitatsklinikum GmBH
Linz, 4021, Austria
Medical University of Vienna
Vienna, 1160, Austria
AZ Sint-Jan Brugge-Oostende
Bruges, 8000, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Antwerp University Hospital
Edegem, 2650, Belgium
C H de la Cote Basque, Service d'Hematologie
Bayonne, 64100, France
CHD Vendee, Onco-hematologie
La Roche-sur-Yon, 85925, France
Centre Hospitalier du Mans
Le Mans, F720000, France
Centre Hospitalier de Mulhouse
Mulhouse, 68100, France
Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie
Poitiers, 86021, France
Institut Gustave Roussy
Villejuif, 94805, France
Klinikum Mutterhaus Feldstr
Trier, Rhineland-Palatinate, Germany
Hamatologisch-Onkolgische Praxis
Nordheim, Stolberg, 52222, Germany
Universitatsklinikum Halle
Halle, 06120, Germany
Munich Municipal Hospital
Munich, 80804, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Universitatsklinikum Ulm
Ulm, 89081, Germany
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
Aviano, 33081, Italy
Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
IRCCS AOU Policlinico San Martino
Genova, 16132, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.
Meldola, 47014, Italy
UOC Oncoematologia
Napoli, 80131, Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121, Italy
Infermi Hospital Rimini
Rimini, 47923, Italy
Universita Cattolica del Sacro Cuore
Roma, 00168, Italy
IRCCS Regina Elena National Cancer Institute
Rome, 00144, Italy
Azienda Ospedaliera Santa Maria
Terni, 05100, Italy
Ospedale DellAngelo Di Mestre Umberto I
Venice, 30174, Italy
North Shore Hospital
Auckland, 0622, New Zealand
Southern District Hospital
Dunedin, 9054, New Zealand
Szpital Uniwersytecki nr 2 im.
Bydgoszcz, 85-168, Poland
Pratia MCM Krakow
Krakow, 30-510, Poland
ojewodzkie Wielospecjalistyczne Centrum
Lodz, 93-510, Poland
Primary Specialty Oncology
Warsaw, 02-034, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776, Poland
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw, 53-439, Poland
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
The Catholic University of Korea-Seoul St. Marys Hospital
Seoul, 6591, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitari Mutua Terrasa
Barcelona, 08221, Spain
ICO-Hospital Duran i Reynals
Barcelona, 08908, Spain
MD Anderson Cancer Center
Madrid, 28033, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario Quiron Salud Madrid
Madrid, 28223, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
Hospital Clinico de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Virgen del Rocio
Seville, 41013, Spain
Miguel Servet Hospital
Zaragoza, 50009, Spain
Ente Ospedaliero Cantonale (EOC)
Bellinzona, 6500, Switzerland
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Chi-Mei Medical Center, Liouying
Tainan, 736, Taiwan
National Taiwan University Hospital NTUH
Taipei, 10002, Taiwan
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Rhyl, Denbighire, LL185UJ, United Kingdom
Royal Marsden Hospital
London, Sutton, SM25PT, United Kingdom
Nottingham University Hospital
Nottingham, UK, NG51PB, United Kingdom
Belfast Health and Social Care Trust - Belfast City Hospital
Belfast, 28040, United Kingdom
Royal Cornwall Hospital
Cornwell, TR1 3LJ, United Kingdom
e Clatterbridge Cancer Centre
Liverpool, L78XP, United Kingdom
Royal Liverpool University Hospital
Liverpool, L78XP, United Kingdom
Lewisham and Greenwich University Hospital Lewisham
London, SE136LH, United Kingdom
St George's Hospital
London, SW170QT, United Kingdom
Centre for Haematology, Imperial College London
London, W12ONN, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, NR4 7UY, United Kingdom
Oxford University Hospitals
Oxford, 0X46LB, United Kingdom
Royal Hallamshire Hospital
Sheffield, S102JF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was closed prematurely for business reasons.
Results Point of Contact
- Title
- Richard Ghalie, MD CMO
- Organization
- MEI Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2018
First Posted
December 7, 2018
Study Start
June 25, 2019
Primary Completion
March 24, 2023
Study Completion
March 24, 2023
Last Updated
December 31, 2024
Results First Posted
February 1, 2024
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share