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

January 8, 2024 updated by: MEI Pharma, Inc.

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Sydney, Australia, NSW2170
        • Liverpool Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula and South Eastern Haematology and Oncology Group
    • Western Australia
      • West Perth, Western Australia, Australia, 6005
        • The Perth Blood Institute
  • Austria
      • Linz, Austria, 4021
        • Kepler Universitätsklinikum GmbH
      • Vienna, Austria, 1160
        • Medical University of Vienna
  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan Brugge-Oostende
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Edegem, Belgium, 2650
        • Antwerp University Hospital
  • France
      • Bayonne, France, 64100
        • C H de la Cote Basque, Service d'Hematologie
      • La Roche-Sur-Yon Cedex 9, France, 85925
        • CHD Vendee, Onco-hematologie
      • Le Mans, France, F720000
        • Centre Hospitalier Du Mans
      • Mulhouse, France, 68100
        • Centre Hospitalier de Mulhouse
      • Poitiers, France, 86021
        • Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Halle, Germany, 06120
        • Universitätsklinikum Halle
      • Munich, Germany, 80804
        • Munich Municipal Hospital
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm
    • Rheinland-Pfalz
      • Trier, Rheinland-Pfalz, Germany
        • Klinikum Mutterhaus Feldstr
    • Stolberg
      • Nordheim, Stolberg, Germany, 52222
        • Hamatologisch-Onkolgische Praxis
  • Italy
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
      • Bologna, Italy, 40138
        • Policlinico Sant'Orsola Malpighi
      • Genova, Italy, 16132
        • IRCCS AOU Policlinico San Martino
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.
      • Napoli, Italy, 80131
        • UOC Oncoematologia
      • Ravenna, Italy, 48121
        • Ospedale Santa Maria delle Croci
      • Rimini, Italy, 47923
        • Infermi Hospital Rimini
      • Roma, Italy, 00168
        • Universita Cattolica del Sacro Cuore
      • Rome, Italy, 00144
        • IRCCS Regina Elena National Cancer Institute
      • Terni, Italy, 05100
        • Azienda Ospedaliera Santa Maria
      • Venice, Italy, 30174
        • Ospedale DellAngelo Di Mestre Umberto I
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 6591
        • The Catholic University of Korea-Seoul St. Marys Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital
  • New Zealand
      • Auckland, New Zealand, 0622
        • North Shore Hospital
      • Dunedin, New Zealand, 9054
        • Southern District Hospital
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im.
      • Kraków, Poland, 30-510
        • Pratia MCM Krakow
      • Warszawa, Poland, 02-776
        • Instytut Hematologii i Transfuzjologii
      • Warszawa, Poland, 02-034
        • Primary Specialty Oncology
      • Wroclaw, Poland, 53-439
        • Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
      • Łódź, Poland, 93-510
        • ojewodzkie Wielospecjalistyczne Centrum
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08221
        • Hospital Universitari Mutua Terrasa
      • Barcelona, Spain, 08908
        • ICO-Hospital Duran i Reynals
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center
      • Madrid, Spain, 28223
        • Hospital Universitario Quiron Salud Madrid
      • Pamplona, Spain, 31008
        • Complejo Hospitalario de Navarra
      • Salamanca, Spain, 37007
        • Hospital Clinico De Salamanca
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Zaragoza, Spain, 50009
        • Miguel Servet Hospital
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Ente Ospedaliero Cantonale (EOC)
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 736
        • Chi-Mei Medical Center, Liouying
      • Tainan City, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei City, Taiwan, 10002
        • National Taiwan University Hospital NTUH
  • United Kingdom
      • Belfast, United Kingdom, 28040
        • Belfast Health and Social Care Trust - Belfast City Hospital
      • Cornwell, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital
      • Liverpool, United Kingdom, L78XP
        • e Clatterbridge Cancer Centre
      • Liverpool, United Kingdom, L78XP
        • Royal Liverpool University Hospital
      • London, United Kingdom, SE136LH
        • Lewisham and Greenwich University Hospital Lewisham
      • London, United Kingdom, SW170QT
        • St George's Hospital
      • London, United Kingdom, W12ONN
        • Centre for Haematology, Imperial College London
      • Manchester, United Kingdom, M20
        • The Christie NHS Foundation Trust
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital Nhs Foundation Trust
      • Oxford, United Kingdom, 0X46LB
        • Oxford University Hospitals
      • Sheffield, United Kingdom, S102JF
        • Royal Hallamshire Hospital
    • Denbighire
      • Rhyl, Denbighire, United Kingdom, LL185UJ
        • North Wales Cancer Treatment Centre, Glan Clwyd Hospital
    • Sutton
      • London, Sutton, United Kingdom, SM25PT
        • Royal Marsden Hospital
    • UK
      • Nottingham, UK, United Kingdom, NG51PB
        • Nottingham University Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Oncology Institute of Hope and Innovation
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc.
      • Beverly Hills, California, United States, 90211
        • Tower Hematology Oncology
      • Downey, California, United States, 90241
        • The Oncology Institute of Hope and Innovation
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffit Cancer Center
      • Weston, Florida, United States, 333331
        • Cleveland Clinic-Florida
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Niles, Illinois, United States, 61761
        • Advocate Health & Hospitals Corporation
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Investigative Clinical Research of Indiana LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical School
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Frontier Cancer Center
    • Nevada
      • Henderson, Nevada, United States, 89052
        • The Oncology Institute of Hope and Innovation
    • New Jersey
      • 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
        • Memorial Sloan Kettering
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering
      • Lake Success, New York, United States, 11042
        • Clinical Research Alliance
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University
    • Texas
      • Houston, Texas, United States, 77056
        • Renovatio Clinical
    • Washington
      • Edmonds, Washington, United States, 98026
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates PS
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Carbone Cancer Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).
Drug: Zandelisib (ME-401)
Zandelisib (ME-401) 60 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL
Time Frame: 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
3 years 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 2 years
Overall survival will be measured as the time from initiation of treatment (Day 1) until death
2 years
Duration of Response (DOR)
Time Frame: 3 years 9 months
Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression
3 years 9 months
Complete Response (CR) Rate
Time Frame: 3 years 9 months
Complete response rate will be measured by the number of subjects that achieve CR
3 years 9 months
Progression-free Survival (PFS)
Time Frame: 3 years 9 months
Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death
3 years 9 months
Overall Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame: 3 years 9 months
The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE.
3 years 9 months
PK of ME-401
Time Frame: 3 years 9 months
The PK of ME-401 will be determined by the peak plasma concentration (Cmax)
3 years 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MEI Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2019

Primary Completion (Actual)

March 24, 2023

Study Completion (Actual)

March 24, 2023

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME-401-003
  • 2018-002896-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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