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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ClinicalTrials.gov Identifier: NCT03768505 |
Recruitment Status :
Active, not recruiting
First Posted : December 7, 2018
Last Update Posted : January 13, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Follicular Lymphoma (FL) Non Hodgkin Lymphoma Marginal Zone Lymphoma | Drug: Zandelisib (ME-401) | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Treatment with Zandelisib (ME-401) (60 mg) given orally once a day on an intermittent schedule |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | June 25, 2019 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | April 2025 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768505

United States, Arizona | |
Oncology Institute of Hope and Innovation | |
Tucson, Arizona, United States, 85710 | |
United States, California | |
Pacific Cancer Medical Center, Inc. | |
Anaheim, California, United States, 92801 | |
Tower Hematology Oncology | |
Beverly Hills, California, United States, 90211 | |
The Oncology Institute of Hope and Innovation | |
Downey, California, United States, 90241 | |
Sharp Memorial Hospital | |
San Diego, California, United States, 92123 | |
United States, Florida | |
H. Lee Moffit Cancer Center | |
Tampa, Florida, United States, 33612 | |
Cleveland Clinic-Florida | |
Weston, Florida, United States, 333331 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
Advocate Health & Hospitals Corporation | |
Niles, Illinois, United States, 61761 | |
United States, Indiana | |
Investigative Clinical Research of Indiana LLC | |
Indianapolis, Indiana, United States, 46260 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
University of Michigan Medical School | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Montana | |
St. Vincent Frontier Cancer Center | |
Billings, Montana, United States, 59102 | |
United States, Nevada | |
The Oncology Institute of Hope and Innovation | |
Henderson, Nevada, United States, 89052 | |
United States, New Jersey | |
Memorial Sloan Kettering | |
Basking Ridge, New Jersey, United States, 07920 | |
Memorial Sloan Kettering | |
Middletown, New Jersey, United States, 07748 | |
Memorial Sloan Kettering | |
Montvale, New Jersey, United States, 07645 | |
United States, New Mexico | |
San Juan Oncology | |
Farmington, New Mexico, United States, 87401 | |
United States, New York | |
Memorial Sloan Kettering | |
Commack, New York, United States, 11725 | |
Memorial Sloan Kettering | |
Harrison, New York, United States, 10604 | |
Clinical Research Alliance | |
Lake Success, New York, United States, 11042 | |
Memorial Sloan Kettering | |
New York, New York, United States, 10065 | |
Memorial Sloan Kettering | |
Uniondale, New York, United States, 11553 | |
United States, North Carolina | |
Duke Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Renovatio Clinical | |
Houston, Texas, United States, 77056 | |
United States, Washington | |
Swedish Cancer Institute | |
Edmonds, Washington, United States, 98026 | |
Swedish Cancer Institute | |
Seattle, Washington, United States, 98104 | |
Medical Oncology Associates PS | |
Spokane, Washington, United States, 99208 | |
United States, Wisconsin | |
University of Wisconsin Carbone Cancer Center | |
Madison, Wisconsin, United States, 53705 | |
Marshfield Medical Center | |
Marshfield, Wisconsin, United States, 54449 | |
Australia, Victoria | |
Peninsula and South Eastern Haematology and Oncology Group | |
Frankston, Victoria, Australia, 3199 | |
Australia, Western Australia | |
The Perth Blood Institute | |
West Perth, Western Australia, Australia, 6005 | |
Australia | |
Liverpool Hospital | |
Sydney, Australia, NSW2170 | |
Austria | |
Kepler Universitatsklinikum GmBH | |
Linz, Austria, 4021 | |
Medical University of Vienna | |
Vienna, Austria, 1160 | |
Belgium | |
AZ Sint-Jan Brugge-Oostende | |
Brugge, Belgium, 8000 | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
Cliniques Universitaires Saint-Luc | |
Brussels, Belgium, 1200 | |
Antwerp University Hospital | |
Edegem, Belgium, 2650 | |
France | |
C H de la Cote Basque, Service d'Hematologie | |
Bayonne, France, 64100 | |
CHD Vendee, Onco-hematologie | |
La Roche-Sur-Yon Cedex 9, France, 85925 | |
Centre Hospitalier du Mans | |
Le Mans, France, F720000 | |
Centre Hospitalier de Mulhouse | |
Mulhouse, France, 68100 | |
Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie | |
Poitiers, France, 86021 | |
Institut Gustave Roussy | |
Villejuif, France, 94805 | |
Germany | |
Klinikum Mutterhaus Feldstr | |
Trier, Rheinland-Pfalz, Germany | |
Hamatologisch-Onkolgische Praxis | |
Nordheim, Stolberg, Germany, 52222 | |
Universitatsklinikum Halle | |
Halle, Germany, 06120 | |
Munich Municipal Hospital | |
Munich, Germany, 80804 | |
Universitatsklinikum Munster | |
Münster, Germany, 48149 | |
Universitatsklinikum Ulm | |
Ulm, Germany, 89081 | |
Italy | |
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS | |
Aviano, Italy, 33081 | |
Policlinico Sant'Orsola Malpighi | |
Bologna, Italy, 40138 | |
IRCCS AOU Policlinico San Martino | |
Genova, Italy, 16132 | |
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T. | |
Meldola, Italy, 47014 | |
UOC Oncoematologia | |
Napoli, Italy, 80131 | |
Ospedale Santa Maria delle Croci | |
Ravenna, Italy, 48121 | |
Infermi Hospital Rimini | |
Rimini, Italy, 47923 | |
Universita Cattolica del Sacro Cuore | |
Roma, Italy, 00168 | |
IRCCS Regina Elena National Cancer Institute | |
Rome, Italy, 00144 | |
Azienda Ospedaliera Santa Maria | |
Terni, Italy, 05100 | |
Ospedale DellAngelo Di Mestre Umberto I | |
Venice, Italy, 30174 | |
Korea, Republic of | |
Dong-A University Hospital | |
Busan, Korea, Republic of, 49201 | |
Pusan National University Hospital | |
Busan, Korea, Republic of, 49241 | |
Korea University Anam Hospital | |
Seoul, Korea, Republic of, 02841 | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 03080 | |
Asan Medical Center | |
Seoul, Korea, Republic of, 05505 | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 06351 | |
Ewha Womans University Mokdong Hospital | |
Seoul, Korea, Republic of, 07985 | |
The Catholic University of Korea-Seoul St. Marys Hospital | |
Seoul, Korea, Republic of, 6591 | |
Ulsan University Hospital | |
Ulsan, Korea, Republic of, 44033 | |
New Zealand | |
North Shore Hospital | |
Auckland, New Zealand, 0622 | |
Southern District Hospital | |
Dunedin, New Zealand, 9054 | |
Poland | |
Szpital Uniwersytecki nr 2 im. | |
Bydgoszcz, Poland, 85-168 | |
Pratia MCM Krakow | |
Kraków, Poland, 30-510 | |
Primary Specialty Oncology | |
Warszawa, Poland, 02-034 | |
Instytut Hematologii i Transfuzjologii | |
Warszawa, Poland, 02-776 | |
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku | |
Wroclaw, Poland, 53-439 | |
ojewodzkie Wielospecjalistyczne Centrum | |
Łódź, Poland, 93-510 | |
Spain | |
Hospital Universitario de Canarias | |
La Laguna, Tenerife, Spain, 38320 | |
Hospital Universitari Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital Universitari Mutua Terrasa | |
Barcelona, Spain, 08221 | |
ICO-Hospital Duran i Reynals | |
Barcelona, Spain, 08908 | |
MD Anderson Cancer Center | |
Madrid, Spain, 28033 | |
Hospital Universitario Ramon y Cajal | |
Madrid, Spain, 28034 | |
Fundacion Jimenez Diaz | |
Madrid, Spain, 28040 | |
Hospital Universitario Quiron Salud Madrid | |
Madrid, Spain, 28223 | |
Complejo Hospitalario de Navarra | |
Pamplona, Spain, 31008 | |
Hospital Clinico de Salamanca | |
Salamanca, Spain, 37007 | |
Hospital Universitario Virgen Macarena | |
Sevilla, Spain, 41009 | |
Hospital Virgen del Rocio | |
Sevilla, Spain, 41013 | |
Miguel Servet Hospital | |
Zaragoza, Spain, 50009 | |
Switzerland | |
Ente Ospedaliero Cantonale (EOC) | |
Bellinzona, Switzerland, 6500 | |
Taiwan | |
China Medical University Hospital | |
Taichung, Taiwan, 40447 | |
National Cheng Kung University Hospital | |
Tainan City, Taiwan, 70403 | |
Chi-Mei Medical Center, Liouying | |
Tainan, Taiwan, 736 | |
National Taiwan University Hospital NTUH | |
Taipei City, Taiwan, 10002 | |
United Kingdom | |
North Wales Cancer Treatment Centre, Glan Clwyd Hospital | |
Rhyl, Denbighire, United Kingdom, LL185UJ | |
Royal Marsden Hospital | |
London, Sutton, United Kingdom, SM25PT | |
Nottingham University Hospital | |
Nottingham, UK, United Kingdom, NG51PB | |
Belfast Health and Social Care Trust - Belfast City Hospital | |
Belfast, United Kingdom, 28040 | |
Royal Cornwall Hospital | |
Cornwell, United Kingdom, TR1 3LJ | |
e Clatterbridge Cancer Centre | |
Liverpool, United Kingdom, L78XP | |
Royal Liverpool University Hospital | |
Liverpool, United Kingdom, L78XP | |
Lewisham and Greenwich University Hospital Lewisham | |
London, United Kingdom, SE136LH | |
St George's Hospital | |
London, United Kingdom, SW170QT | |
Centre for Haematology, Imperial College London | |
London, United Kingdom, W12ONN | |
The Christie NHS Foundation Trust | |
Manchester, United Kingdom, M20 | |
Norfolk and Norwich University Hospital NHS Foundation Trust | |
Norwich, United Kingdom, NR4 7UY | |
Oxford University Hospitals | |
Oxford, United Kingdom, 0X46LB | |
Royal Hallamshire Hospital | |
Sheffield, United Kingdom, S102JF |
Responsible Party: | MEI Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT03768505 |
Other Study ID Numbers: |
ME-401-003 2018-002896-17 ( EudraCT Number ) |
First Posted: | December 7, 2018 Key Record Dates |
Last Update Posted: | January 13, 2023 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphoma Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Lymphoma, B-Cell |