Non Hodgkin Lymphoma Clinical Trial

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

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

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT03768505

Recruitment Status:

Recruiting

Sponsor:

MEI Pharma, Inc.

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There are 113 Locations for this study

See Locations Near You

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, 33333, 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
Northwest Medical Specialties
Tacoma Washington, 98405, 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 , NSW21, Australia
Kepler Universitatsklinikum GmBH
Linz , 4021, Austria
Medical University of Vienna
Vienna , 1160, Austria
AZ Sint-Jan Brugge-Oostende
Brugge , 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 Cedex 9 , 85925, France
Centre Hospitalier du Mans
Le Mans , F7200, 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 Rheinland-Pfalz, , 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
Dong-A University Hospital
Busan , 49201, Korea, Republic of More Info
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of More Info
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul , 07985, Korea, Republic of
The Catholic University of Korea-Seoul St. Marys Hospital
Seoul , 6591, Korea, Republic of
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of
North Shore Hospital
Auckland , 0622, New Zealand More Info
Leo Gonzales-Perez
Contact
64 9 486 8920 ext 43702
[email protected]
Nuria Lopez Rozain
Contact
[email protected]
Southern District Hospital
Dunedin , 9054, New Zealand More Info
Szpital Uniwersytecki nr 2 im.
Bydgoszcz , 85-16, Poland
Pratia MCM Krakow
Kraków , 30-51, Poland More Info
Primary Specialty Oncology
Warszawa , 02-03, Poland
Instytut Hematologii i Transfuzjologii
Warszawa , 02-77, Poland
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw , 53-43, Poland
ojewodzkie Wielospecjalistyczne Centrum
Łódź , 93-51, Poland
Hospital Universitario de Canarias
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
Sevilla , 41009, Spain
Hospital Virgen del Rocio
Sevilla , 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 City , 70403, Taiwan
Chi-Mei Medical Center, Liouying
Tainan , 736, Taiwan
National Taiwan University Hospital NTUH
Taipei City , 10002, Taiwan
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Rhyl Denbighire, LL185, United Kingdom
Royal Marsden Hospital
London Sutton, SM25P, United Kingdom
Nottingham University Hospital
Nottingham UK, NG51P, United Kingdom
Belfast Health and Social Care Trust - Belfast City Hospital
Belfast , 28040, United Kingdom
Royal Cornwall Hospital
Cornwell , TR1 3, 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 , SE136, United Kingdom
St George's Hospital
London , SW170, United Kingdom
Centre for Haematology, Imperial College London
London , W12ON, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich , NR4 7, United Kingdom
Oxford University Hospitals
Oxford , 0X46L, United Kingdom
Royal Hallamshire Hospital
Sheffield , S102J, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT03768505

Recruitment Status:

Recruiting

Sponsor:


MEI Pharma, Inc.

How clear is this clinincal trial information?

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