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

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03768505
• Other study ID #: ME-401-003
• Secondary ID: 2018-002896-17
• Status: Terminated
• Phase: Phase 2
• Start date: June 25, 2019
• Est. completion date: March 24, 2023

Study information

• Verified date: December 2022
• Source: MEI Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Follicular Lymphoma (FL)
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular
• Marginal Zone Lymphoma
• Non Hodgkin Lymphoma

Intervention

Drug:
• Zandelisib (ME-401)
Zandelisib (ME-401) 60 mg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MEI Pharma, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  France,  Germany,  Italy,  Korea, Republic of,  New Zealand,  Poland,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

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