Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
- Conditions
- Non Hodgkin LymphomaFollicular Lymphoma (FL)Marginal Zone Lymphoma
- Interventions
- Registration Number
- NCT03768505
- Lead Sponsor
- MEI Pharma, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 169
-
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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zandelisib (ME-401) open label Zandelisib (ME-401) Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL 3 years 9 months ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) 3 years 9 months Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression
Overall Incidence of Treatment Emergent Adverse Events (TEAEs) 3 years 9 months The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE.
Complete Response (CR) Rate 3 years 9 months Complete response rate will be measured by the number of subjects that achieve CR
Progression-free Survival (PFS) 3 years 9 months Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death
Overall Survival 2 years Overall survival will be measured as the time from initiation of treatment (Day 1) until death
PK of ME-401 3 years 9 months The PK of ME-401 will be determined by the peak plasma concentration (Cmax)
Trial Locations
- Locations (107)
CHD Vendee, Onco-hematologie
🇫🇷La Roche-Sur-Yon Cedex 9, France
Tower Hematology Oncology
🇺🇸Beverly Hills, California, United States
Memorial Sloan Kettering
🇺🇸Uniondale, New York, United States
Universita Cattolica del Sacro Cuore
🇮🇹Roma, Italy
Marshfield Medical Center
🇺🇸Marshfield, Wisconsin, United States
Universitatsklinikum Halle
🇩🇪Halle, Germany
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
🇮🇹Aviano, Italy
AZ Sint-Jan Brugge-Oostende
🇧🇪Brugge, Belgium
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States
Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie
🇫🇷Poitiers, France
Advocate Health & Hospitals Corporation
🇺🇸Niles, Illinois, United States
UOC Oncoematologia
🇮🇹Napoli, Italy
Pacific Cancer Medical Center, Inc.
🇺🇸Anaheim, California, United States
H. Lee Moffit Cancer Center
🇺🇸Tampa, Florida, United States
Cleveland Clinic-Florida
🇺🇸Weston, Florida, United States
San Juan Oncology
🇺🇸Farmington, New Mexico, United States
Liverpool Hospital
🇦🇺Sydney, Australia
Institut Jules Bordet
🇧🇪Brussels, Belgium
St. Vincent Frontier Cancer Center
🇺🇸Billings, Montana, United States
University of Michigan Medical School
🇺🇸Ann Arbor, Michigan, United States
Centre Hospitalier du Mans
🇫🇷Le Mans, France
Klinikum Mutterhaus Feldstr
🇩🇪Trier, Rheinland-Pfalz, Germany
Munich Municipal Hospital
🇩🇪Munich, Germany
Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
IRCCS AOU Policlinico San Martino
🇮🇹Genova, Italy
Azienda Ospedaliera Santa Maria
🇮🇹Terni, Italy
Stony Brook University
🇺🇸Stony Brook, New York, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Clinical Research Alliance
🇺🇸Lake Success, New York, United States
Medical Oncology Associates PS
🇺🇸Spokane, Washington, United States
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Szpital Uniwersytecki nr 2 im.
🇵🇱Bydgoszcz, Poland
Primary Specialty Oncology
🇵🇱Warszawa, Poland
Institut Gustave Roussy
🇫🇷Villejuif, France
Hamatologisch-Onkolgische Praxis
🇩🇪Nordheim, Stolberg, Germany
ICO-Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Southern District Hospital
🇳🇿Dunedin, New Zealand
Infermi Hospital Rimini
🇮🇹Rimini, Italy
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Chi-Mei Medical Center, Liouying
🇨🇳Tainan, Taiwan
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Ospedale Santa Maria delle Croci
🇮🇹Ravenna, Italy
IRCCS Regina Elena National Cancer Institute
🇮🇹Rome, Italy
Ospedale DellAngelo Di Mestre Umberto I
🇮🇹Venice, Italy
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
MD Anderson Cancer Center
🇪🇸Madrid, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Tenerife, Spain
Hospital Universitari Mutua Terrasa
🇪🇸Barcelona, Spain
Belfast Health and Social Care Trust - Belfast City Hospital
🇬🇧Belfast, United Kingdom
Hospital Universitario Quiron Salud Madrid
🇪🇸Madrid, Spain
Royal Marsden Hospital
🇬🇧London, Sutton, United Kingdom
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea-Seoul St. Marys Hospital
🇰🇷Seoul, Korea, Republic of
Pratia MCM Krakow
🇵🇱Kraków, Poland
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
🇵🇱Wroclaw, Poland
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
North Shore Hospital
🇳🇿Auckland, New Zealand
Instytut Hematologii i Transfuzjologii
🇵🇱Warszawa, Poland
Norfolk and Norwich University Hospital NHS Foundation Trust
🇬🇧Norwich, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Oxford University Hospitals
🇬🇧Oxford, United Kingdom
The Oncology Institute of Hope and Innovation
🇺🇸Henderson, Nevada, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
ojewodzkie Wielospecjalistyczne Centrum
🇵🇱Łódź, Poland
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Renovatio Clinical
🇺🇸Houston, Texas, United States
Duke Cancer Center
🇺🇸Durham, North Carolina, United States
Antwerp University Hospital
🇧🇪Edegem, Belgium
China Medical University Hospital
🇨🇳Taichung, Taiwan
Kepler Universitatsklinikum GmBH
🇦🇹Linz, Austria
Ente Ospedaliero Cantonale (EOC)
🇨🇭Bellinzona, Switzerland
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Centre Hospitalier de Mulhouse
🇫🇷Mulhouse, France
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Hospital Clinico de Salamanca
🇪🇸Salamanca, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Universitatsklinikum Munster
🇩🇪Münster, Germany
Nottingham University Hospital
🇬🇧Nottingham, UK, United Kingdom
Oncology Institute of Hope and Innovation
🇺🇸Tucson, Arizona, United States
Investigative Clinical Research of Indiana LLC
🇺🇸Indianapolis, Indiana, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
The Perth Blood Institute
🇦🇺West Perth, Western Australia, Australia
Peninsula and South Eastern Haematology and Oncology Group
🇦🇺Frankston, Victoria, Australia
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Medical University of Vienna
🇦🇹Vienna, Austria
C H de la Cote Basque, Service d'Hematologie
🇫🇷Bayonne, France
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.
🇮🇹Meldola, Italy
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Miguel Servet Hospital
🇪🇸Zaragoza, Spain
National Cheng Kung University Hospital
🇨🇳Tainan City, Taiwan
National Taiwan University Hospital NTUH
🇨🇳Taipei City, Taiwan
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
🇬🇧Rhyl, Denbighire, United Kingdom
Royal Cornwall Hospital
🇬🇧Cornwell, United Kingdom
e Clatterbridge Cancer Centre
🇬🇧Liverpool, United Kingdom
Lewisham and Greenwich University Hospital Lewisham
🇬🇧London, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
Centre for Haematology, Imperial College London
🇬🇧London, United Kingdom
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Universitatsklinikum Ulm
🇩🇪Ulm, Germany
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom