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Follicular Lymphoma (FL)Phase 2NCT03768505

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

A Phase 2 study testing Zandelisib (ME-401) in people with Follicular Lymphoma (FL) and Non Hodgkin Lymphoma, run by MEI Pharma, Inc. at 115 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zandelisib (ME-401)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
115 sitesin 14 countries
Study dates
25 Jun 2019to 24 Mar 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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%

Who cannot join

  • 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

Trial locations and contacts

115 sites in 14 countries.

115 sites in 14 countries

United States34 sites

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • University of Michigan Medical School

    Ann Arbor, Michigan, 48109

  • Memorial Sloan Kettering

    Basking Ridge, New Jersey, 07920

  • Tower Hematology Oncology

    Beverly Hills, California, 90211

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Memorial Sloan Kettering

    Commack, New York, 11725

  • The Oncology Institute of Hope and Innovation

    Downey, California, 90241

  • Duke Cancer Center

    Durham, North Carolina, 27710

  • Swedish Cancer Institute

    Edmonds, Washington, 98026

  • San Juan Oncology

    Farmington, New Mexico, 87401

  • Memorial Sloan Kettering

    Harrison, New York, 10604

  • The Oncology Institute of Hope and Innovation

    Henderson, Nevada, 89052

  • Renovatio Clinical

    Houston, Texas, 77056

  • Investigative Clinical Research of Indiana LLC

    Indianapolis, Indiana, 46260

  • Clinical Research Alliance

    Lake Success, New York, 11042

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53705

  • Marshfield Medical Center

    Marshfield, Wisconsin, 54449

  • Memorial Sloan Kettering

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering

    Montvale, New Jersey, 07645

  • Vanderbilt University

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering

    New York, New York, 10065

  • Advocate Health & Hospitals Corporation

    Niles, Illinois, 61761

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Medical Oncology Associates PS

    Spokane, Washington, 99208

  • Stony Brook University

    Stony Brook, New York, 11794

  • H. Lee Moffit Cancer Center

    Tampa, Florida, 33612

  • Oncology Institute of Hope and Innovation

    Tucson, Arizona, 85710

  • Memorial Sloan Kettering

    Uniondale, New York, 11553

  • Cleveland Clinic-Florida

    Weston, Florida, 333331

Other trials in United States

United Kingdom14 sites

  • Belfast Health and Social Care Trust - Belfast City Hospital

    Belfast, 28040

  • Royal Cornwall Hospital

    Cornwell, TR1 3LJ

  • e Clatterbridge Cancer Centre

    Liverpool, L78XP

  • Royal Liverpool University Hospital

    Liverpool, L78XP

  • Royal Marsden Hospital

    London, Sutton, SM25PT

  • Lewisham and Greenwich University Hospital Lewisham

    London, SE136LH

  • St George's Hospital

    London, SW170QT

  • Centre for Haematology, Imperial College London

    London, W12ONN

  • The Christie NHS Foundation Trust

    Manchester, M20

  • Norfolk and Norwich University Hospital NHS Foundation Trust

    Norwich, NR4 7UY

  • Nottingham University Hospital

    Nottingham, UK, NG51PB

  • Oxford University Hospitals

    Oxford, 0X46LB

  • North Wales Cancer Treatment Centre, Glan Clwyd Hospital

    Rhyl, Denbighire, LL185UJ

  • Royal Hallamshire Hospital

    Sheffield, S102JF

Other trials in United Kingdom

Spain13 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitari Mutua Terrasa

    Barcelona, 08221

  • ICO-Hospital Duran i Reynals

    Barcelona, 08908

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario Quiron Salud Madrid

    Madrid, 28223

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Hospital Clinico de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Virgen del Rocio

    Seville, 41013

  • Miguel Servet Hospital

    Zaragoza, 50009

Other trials in Spain

Italy11 sites

  • Centro di Riferimento Oncologico di Aviano (CRO) IRCCS

    Aviano, 33081

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • IRCCS AOU Policlinico San Martino

    Genova, 16132

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.

    Meldola, 47014

  • UOC Oncoematologia

    Naples, 80131

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121

  • Infermi Hospital Rimini

    Rimini, 47923

  • Universita Cattolica del Sacro Cuore

    Roma, 00168

  • IRCCS Regina Elena National Cancer Institute

    Rome, 00144

  • Azienda Ospedaliera Santa Maria

    Terni, 05100

  • Ospedale DellAngelo Di Mestre Umberto I

    Venice, 30174

Other trials in Italy

South Korea9 sites

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Ewha Womans University Mokdong Hospital

    Seoul, 07985

  • The Catholic University of Korea-Seoul St. Marys Hospital

    Seoul, 6591

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

France6 sites

  • C H de la Cote Basque, Service d'Hematologie

    Bayonne, 64100

  • CHD Vendee, Onco-hematologie

    La Roche-sur-Yon, 85925

  • Centre Hospitalier du Mans

    Le Mans, F720000

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68100

  • Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie

    Poitiers, 86021

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany6 sites

  • Universitatsklinikum Halle

    Halle, 06120

  • Munich Municipal Hospital

    Munich, 80804

  • Universitatsklinikum Munster

    Münster, 48149

  • Hamatologisch-Onkolgische Praxis

    Nordheim, Stolberg, 52222

  • Klinikum Mutterhaus Feldstr

    Trier, Rhineland-Palatinate

  • Universitatsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Poland6 sites

  • Szpital Uniwersytecki nr 2 im.

    Bydgoszcz, 85-168

  • Pratia MCM Krakow

    Krakow, 30-510

  • ojewodzkie Wielospecjalistyczne Centrum

    Lodz, 93-510

  • Primary Specialty Oncology

    Warsaw, 02-034

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

  • Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

    Wroclaw, 53-439

Other trials in Poland

Belgium4 sites

  • AZ Sint-Jan Brugge-Oostende

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Antwerp University Hospital

    Edegem, 2650

Other trials in Belgium

Taiwan4 sites

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Chi-Mei Medical Center, Liouying

    Tainan, 736

  • National Taiwan University Hospital NTUH

    Taipei, 10002

Other trials in Taiwan

Australia3 sites

  • Peninsula and South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • Liverpool Hospital

    Sydney, NSW2170

  • The Perth Blood Institute

    West Perth, Western Australia, 6005

Other trials in Australia

Austria2 sites

  • Kepler Universitatsklinikum GmBH

    Linz, 4021

  • Medical University of Vienna

    Vienna, 1160

Other trials in Austria

New Zealand2 sites

  • North Shore Hospital

    Auckland, 0622

  • Southern District Hospital

    Dunedin, 9054

Other trials in New Zealand

Switzerland1 site

  • Ente Ospedaliero Cantonale (EOC)

    Bellinzona, 6500

Other trials in Switzerland

About this study

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)

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

Read the 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.

Being tested
Zandelisib (ME-401)
Medical subject headings
Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zandelisib (ME-401)Drug

    Zandelisib (ME-401) 60 mg

Study groups in NCT03768505
Study groupRoleWhat they receive
Zandelisib (ME-401) open labelExperimentalSubjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
Receives: Drug: Zandelisib (ME-401)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 years 9 months

Secondary outcomes (6)

  1. Duration of Response (DOR)

    Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression

    Measured: 3 years 9 months

  2. Complete Response (CR) Rate

    Complete response rate will be measured by the number of subjects that achieve CR

    Measured: 3 years 9 months

  3. Progression-free Survival (PFS)

    Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death

    Measured: 3 years 9 months

  4. Overall Survival

    Overall survival will be measured as the time from initiation of treatment (Day 1) until death

    Measured: 2 years

  5. Overall Incidence of Treatment Emergent Adverse Events (TEAEs)

    The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE.

    Measured: 3 years 9 months

  6. PK of ME-401

    The PK of ME-401 will be determined by the peak plasma concentration (Cmax)

    Measured: 3 years 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2018
  2. Study start25 Jun 2019
  3. Primary completion24 Mar 2023
  4. Study completion24 Mar 2023

Why it stopped: discontinuation of zandelisib program

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Treatment with Zandelisib (ME-401) (60 mg) given orally once a day on an intermittent schedule
Masking
None (open label)
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03768505
Sponsor's protocol ID
ME-401-003
Other IDs
2018-002896-17, 2018
Status last verified
Dec 2022
First submitted
4 Dec 2018
Last updated
31 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zandelisib (ME-401) in people with Follicular Lymphoma (FL) and Non Hodgkin Lymphoma, run by MEI Pharma, Inc. at 115 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, United Kingdom, Spain, Italy, South Korea and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL (time frame: 3 years 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03768505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.

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