Non Hodgkin Lymphoma Clinical Trial
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)
| Verified date | December 2022 |
| Source | MEI Pharma, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 169 |
| Est. completion date | March 24, 2023 |
| Est. primary completion date | March 24, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Peninsula and South Eastern Haematology and Oncology Group | Frankston | Victoria |
| Australia | Liverpool Hospital | Sydney | |
| Australia | The Perth Blood Institute | West Perth | Western Australia |
| Austria | Kepler Universitatsklinikum GmBH | Linz | |
| Austria | Medical University of Vienna | Vienna | |
| Belgium | AZ Sint-Jan Brugge-Oostende | Brugge | |
| Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
| Belgium | Institut Jules Bordet | Brussels | |
| Belgium | Antwerp University Hospital | Edegem | |
| France | C H de la Cote Basque, Service d'Hematologie | Bayonne | |
| France | CHD Vendee, Onco-hematologie | La Roche-Sur-Yon Cedex 9 | |
| France | Centre Hospitalier du Mans | Le Mans | |
| France | Centre Hospitalier de Mulhouse | Mulhouse | |
| France | Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie | Poitiers | |
| France | Institut Gustave Roussy | Villejuif | |
| Germany | Universitatsklinikum Halle | Halle | |
| Germany | Munich Municipal Hospital | Munich | |
| Germany | Universitatsklinikum Munster | Münster | |
| Germany | Hamatologisch-Onkolgische Praxis | Nordheim | Stolberg |
| Germany | Klinikum Mutterhaus Feldstr | Trier | Rheinland-Pfalz |
| Germany | Universitatsklinikum Ulm | Ulm | |
| Italy | Centro di Riferimento Oncologico di Aviano (CRO) IRCCS | Aviano | |
| Italy | Policlinico Sant'Orsola Malpighi | Bologna | |
| Italy | IRCCS AOU Policlinico San Martino | Genova | |
| Italy | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T. | Meldola | |
| Italy | UOC Oncoematologia | Napoli | |
| Italy | Ospedale Santa Maria delle Croci | Ravenna | |
| Italy | Infermi Hospital Rimini | Rimini | |
| Italy | Universita Cattolica del Sacro Cuore | Roma | |
| Italy | IRCCS Regina Elena National Cancer Institute | Rome | |
| Italy | Azienda Ospedaliera Santa Maria | Terni | |
| Italy | Ospedale DellAngelo Di Mestre Umberto I | Venice | |
| Korea, Republic of | Dong-A University Hospital | Busan | |
| Korea, Republic of | Pusan National University Hospital | Busan | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Ewha Womans University Mokdong Hospital | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | The Catholic University of Korea-Seoul St. Marys Hospital | Seoul | |
| Korea, Republic of | Ulsan University Hospital | Ulsan | |
| New Zealand | North Shore Hospital | Auckland | |
| New Zealand | Southern District Hospital | Dunedin | |
| Poland | Szpital Uniwersytecki nr 2 im. | Bydgoszcz | |
| Poland | Pratia MCM Krakow | Kraków | |
| Poland | ojewodzkie Wielospecjalistyczne Centrum | Lódz | |
| Poland | Instytut Hematologii i Transfuzjologii | Warszawa | |
| Poland | Primary Specialty Oncology | Warszawa | |
| Poland | Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku | Wroclaw | |
| Spain | Hospital Universitari Mutua Terrasa | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | ICO-Hospital Duran i Reynals | Barcelona | |
| Spain | Hospital Universitario de Canarias | La Laguna | Tenerife |
| Spain | Fundacion Jimenez Diaz | Madrid | |
| Spain | Hospital Universitario Quiron Salud Madrid | Madrid | |
| Spain | Hospital Universitario Ramon y Cajal | Madrid | |
| Spain | MD Anderson Cancer Center | Madrid | |
| Spain | Complejo Hospitalario de Navarra | Pamplona | |
| Spain | Hospital Clinico de Salamanca | Salamanca | |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| Spain | Hospital Virgen del Rocio | Sevilla | |
| Spain | Miguel Servet Hospital | Zaragoza | |
| Switzerland | Ente Ospedaliero Cantonale (EOC) | Bellinzona | |
| Taiwan | China Medical University Hospital | Taichung | |
| Taiwan | Chi-Mei Medical Center, Liouying | Tainan | |
| Taiwan | National Cheng Kung University Hospital | Tainan City | |
| Taiwan | National Taiwan University Hospital NTUH | Taipei City | |
| United Kingdom | Belfast Health and Social Care Trust - Belfast City Hospital | Belfast | |
| United Kingdom | Royal Cornwall Hospital | Cornwell | |
| United Kingdom | e Clatterbridge Cancer Centre | Liverpool | |
| United Kingdom | Royal Liverpool University Hospital | Liverpool | |
| United Kingdom | Centre for Haematology, Imperial College London | London | |
| United Kingdom | Lewisham and Greenwich University Hospital Lewisham | London | |
| United Kingdom | Royal Marsden Hospital | London | Sutton |
| United Kingdom | St George's Hospital | London | |
| United Kingdom | The Christie NHS Foundation Trust | Manchester | |
| United Kingdom | Norfolk and Norwich University Hospital NHS Foundation Trust | Norwich | |
| United Kingdom | Nottingham University Hospital | Nottingham | UK |
| United Kingdom | Oxford University Hospitals | Oxford | |
| United Kingdom | North Wales Cancer Treatment Centre, Glan Clwyd Hospital | Rhyl | Denbighire |
| United Kingdom | Royal Hallamshire Hospital | Sheffield | |
| United States | Pacific Cancer Medical Center, Inc. | Anaheim | California |
| United States | University of Michigan Medical School | Ann Arbor | Michigan |
| United States | Memorial Sloan Kettering | Basking Ridge | New Jersey |
| United States | Tower Hematology Oncology | Beverly Hills | California |
| United States | St. Vincent Frontier Cancer Center | Billings | Montana |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Memorial Sloan Kettering | Commack | New York |
| United States | The Oncology Institute of Hope and Innovation | Downey | California |
| United States | Duke Cancer Center | Durham | North Carolina |
| United States | Swedish Cancer Institute | Edmonds | Washington |
| United States | San Juan Oncology | Farmington | New Mexico |
| United States | Memorial Sloan Kettering | Harrison | New York |
| United States | The Oncology Institute of Hope and Innovation | Henderson | Nevada |
| United States | Renovatio Clinical | Houston | Texas |
| United States | Investigative Clinical Research of Indiana LLC | Indianapolis | Indiana |
| United States | Clinical Research Alliance | Lake Success | New York |
| United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
| United States | Marshfield Medical Center | Marshfield | Wisconsin |
| United States | Memorial Sloan Kettering | Middletown | New Jersey |
| United States | Memorial Sloan Kettering | Montvale | New Jersey |
| United States | Vanderbilt University | Nashville | Tennessee |
| United States | Memorial Sloan Kettering | New York | New York |
| United States | Advocate Health & Hospitals Corporation | Niles | Illinois |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Sharp Memorial Hospital | San Diego | California |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Medical Oncology Associates PS | Spokane | Washington |
| United States | Stony Brook University | Stony Brook | New York |
| United States | H. Lee Moffit Cancer Center | Tampa | Florida |
| United States | Oncology Institute of Hope and Innovation | Tucson | Arizona |
| United States | Memorial Sloan Kettering | Uniondale | New York |
| United States | Cleveland Clinic-Florida | Weston | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| MEI Pharma, Inc. |
United States, Australia, Austria, Belgium, France, Germany, Italy, Korea, Republic of, New Zealand, Poland, Spain, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Duration of Response (DOR) | Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression | 3 years 9 months | |
| Secondary | Complete Response (CR) Rate | Complete response rate will be measured by the number of subjects that achieve CR | 3 years 9 months | |
| Secondary | Progression-free Survival (PFS) | Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death | 3 years 9 months | |
| Secondary | Overall Survival | Overall survival will be measured as the time from initiation of treatment (Day 1) until death | 2 years | |
| Secondary | Overall Incidence of Treatment Emergent Adverse Events (TEAEs) | The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE. | 3 years 9 months | |
| Secondary | PK of ME-401 | The PK of ME-401 will be determined by the peak plasma concentration (Cmax) | 3 years 9 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Suspended |
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