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Follicular Lymphoma (FL)Phase 3NCT04745832

Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

A Phase 3 study testing Zandelisib, Rituximab and Bendamustine in people with Follicular Lymphoma (FL) and Non Hodgkin Lymphoma, run by MEI Pharma, Inc. at 141 sites in 19 countries.

Terminated

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

Official record
Search all trials

Trial summary

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zandelisib, Rituximab and Bendamustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
141 sitesin 19 countries
Study dates
13 Aug 2021to 20 Mar 2023
Phase
Phase 3
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

  • Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for subjects in Japan and Taiwan
  • Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:
  • FL Gr 1, Gr 2, or Gr 3a
  • MZL (splenic, nodal, or extra-nodal)
  • Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy
  • Subjects must have at least one bi-dimensionally measurable lesion >1.5 cm
Show all 9Show fewer
  • Adequate hematologic parameters at screening unless abnormal values are due to disease
  • Adequate renal and hepatic function
  • Adequate cardiac function based on ECG and LVEF assessments

Who cannot join

  • Histologically confirmed diagnosis of FL Gr 3b or transformed disease
  • Prior therapy with PI3K inhibitors
  • Ongoing or history of drug-induced pneumonitis
  • Known lymphomatous involvement of the central nervous system
  • Tested positive for or active viral infection with hepatitis B or C virus
  • Tested positive or active infection with human immunodeficiency virus
Show all 11Show fewer
  • Tested positive, or active infection with human T-cell leukemia virus type 1
  • Any uncontrolled clinically significant illness
  • History of clinically significant cardiovascular abnormalities such as congestive heart failure
  • History of clinically significant gastrointestinal (GI) conditions
  • Females who are pregnant

Trial locations and contacts

141 sites in 19 countries.

141 sites in 19 countries

Japan25 sites

  • Anjo Kosei Hospital

    Aichi, 446-8602

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

    Aichi, 466-8650

  • Aomori Prefectural Central Hospital

    Aomori, 030-8553

  • Chiba Cancer Center

    Chiba, 260-8717

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Chugoku Central Hospital

    Hiroshima, 720-0001

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • University Hospital Kyoto Prefectural University of Medicine

    Kamigyō-ku, Kyoto, 602-8566

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • National Hospital Organization Kyushu Cancer Center

    Minami, Fukuoka, 811-1395

  • National University Corporation Tohoku University Hospital

    Miyagi, 980-8574

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681

  • National Hospital Organization Nagoya Medical Center

    Naka-ku, Aichi-ken, 460-0001

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Osaka University Hospital

    Osaka, 565-0871

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • Kagoshima University Hospital

    Sakuragaoka, Kagoshima-Shi, Kagoshima, 890-8520

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Tokyo, 113-8677

  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research

    Tokyo, 135-8550

  • Keio University Hospital

    Tokyo, 160-8582

Other trials in Japan

Italy16 sites

  • SOC Oncologia Medica e dei Tumori Immunocorrelati

    Aviano, 33081

  • UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle

    Cuneo, 12100

  • U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

  • U.O. Clinica Ematologica

    Genova, 16132

  • SC Oncologia Medica

    Meldola, 47014

  • UOC Ematologia, Presidio Ospedaliero Papardo

    Messina, 98158

  • UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre

    Mestre, 30174

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

    Milan, 20122

  • Dipartimento di Oncoematologia, Unità Linfomi, Ospedale

    Milan, 20132

  • Divisione Oncoematologia, Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Ospedaliera Ospedali Riuniti Via Sofia

    Palermo, 90146

  • UO Ematologia, Ospedale Civile S.Maria delle Croci

    Ravenna, 48121

  • UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna

    Rimini, 47923

  • Istituti Fisioterapici Ospitalieri

    Roma, 00144

  • S.C. Oncoematologia Azienda Ospedaliera Santa Maria

    Terni, 05110

Other trials in Italy

United States14 sites

  • Alpha Research Institute, LLC

    Baytown, Texas, 77521

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Revive Research Institute

    Farmington Hills, Michigan, 48334

  • Orange Coast Memorial Medical Center

    Fountain Valley, California, 92708

  • Valley Cancer Associates

    Harlingen, Texas, 78550

  • BRCR Medical Center Inc

    Hollywood, Florida, 33021

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Inspira Medical Center Mullica Hill

    Mullica Hill, New Jersey, 08062

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405

  • The Oncology Institute of Hope and Innovation

    Riverside, California, 92506

  • Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center

    Springfield, Missouri, 65804

  • Revive Research Institute

    Sterling Heights, Michigan, 48314

  • The Oncology Institute of Hope and Innovation

    Tucson, Arizona, 85745

Other trials in United States

South Korea13 sites

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Dong-A university Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, 41944

  • Chonnam National University Hwasun Hospital

    Jeollyang, 58128

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea

    Seoul, 06591

  • Ewka Womans University Mokdong Hospital

    Seoul, 07985

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

France9 sites

  • CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte,

    Clermont-Ferrand, 63003

  • Centre Hospitalier De Dunkerque - Service d'hématologie

    Le Mans, 72000

  • Centre Hospitalier du Mans

    Le Mans, 72000

  • Centre Leon Berard

    Lyon, 69373

  • Hôpital Saint-Louis

    Paris, 75010

  • CHU de Bordeaux - Maladies Du Sang, Centre François Magendie

    Pessac, 33600

  • Centre Henri Becquerel, Service d'Hematologie

    Rouen, 76038

  • CHU de Tours, Hôpital Bretonneau Centre

    Tours, 37044

  • Institut De Cancerologie Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain9 sites

  • Hospital Universitario Quironsalud

    Alcorcón, Madrid, 28223

  • Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology

    Barcelona, 08035

  • Hospital Universitario Mútua Terrassa

    Barcelona, 08221

  • Institut Catalá d'Oncologia, Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Complejo Hospitalario de Navarra

    Navarro, 31008

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

United Kingdom9 sites

  • North Wales Cancer Treatment Centre

    Bodelwyddan, Denbighshire, LL18 5UJ

  • Royal Cornwall Hospital

    Cornwell, TR1 3LJ

  • Department of Haematology St. George's University of London

    London, SW17 0RE

  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

    London, SW3 6JJ

  • Imperial College Healthcare NHS Trust Hammersmith Hospital

    London, W12 0HS

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Genesis Care Oxford

    Oxford, OX4 6LB

  • University Hospitals Plymouth NHS Trust, Derriford Hopital

    Plymouth, PL6 8DH

  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

    Surrey Quays, SM2 5PT

Other trials in United Kingdom

Serbia6 sites

  • University Clinical Center of Serbia, Clinic for Hematology

    Belgrade, 11000

  • Zvezdara University Medical Center, Clinical department for Hematology and Oncology

    Belgrade, 11000

  • Clinical Hospital Center "Zemun", Clinic for Internal Medicine, Department for Hematology

    Belgrade, 11080

  • Oncology Institute of Vojvodina, Clinic for Internal Oncology

    Kamenica, 21204

  • University Clinical Center Kragujevac, Clinic for Hematology

    Kragujevac, 34000

  • Clinical Center of Vojvodina, Clinic for Hematology

    Novi Sad, 21000

Other trials in Serbia

Turkey (Türkiye)6 sites

  • Gazi University Health Research and Application Hospital, Hematology Department

    Ankara, 29 06560

  • Istanbul University Istanbul Medical Faculty, Hematology Department

    Istanbul, 34093

  • Erciyes University Medical Faculty, Department of Hematology

    Kayseri, 38039

  • Ondokuz Mayis University Medical Faculty, Hematology Department

    Samsun, 55200

  • Namik Kemal University Hospital

    Tekirdağ, 59100

  • Karadeniz Technical University Medical Faculty Department of Hematology

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Belgium5 sites

  • AZ Sint-Jan Burgge-Oostende AV

    Bruges, 8000

  • UZ Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Antwerpen

    Edegem, 655, 2650

  • Center Hospitalier de Jolimont

    Haine-Saint-Paul, 7100

  • UZ Leuven Campus Gasthuisberg

    Leuven

Other trials in Belgium

Georgia4 sites

  • LTD Israeli-Georgian Medical Research Clinic "Helsicore"

    Tbilisi, 0112

  • M. Zodelava Hematology Center

    Tbilisi, 0112

  • J.S.C. K. Eristavi National Center of Experimental and Clinic

    Tbilisi, 0159

  • LTD "Medinvest" Institute of Hematology and Transfusiology

    Tbilisi, 0186

Other trials in Georgia

Greece4 sites

  • General Hospital of Athens "Laiko", Department of Haematology and Bone Marrow Transplantation

    Athens, 11527

  • University General Hospital of Ioannina, Department of Haematology

    Ioannina, 455 00

  • University General Hospital of Patras "Panagia H. Voitheia"

    Pátrai, 26504

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57010

Other trials in Greece

Poland4 sites

  • Klinika Hematologii, Szpital Uniwersytecki

    Bydgoszcz, 85-168

  • Pratia MCM Krakow

    Krakow, 30-510

  • ARS Medical - Szpital, Oddzial hematologiczny

    Piła, 64-920

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60-185

Other trials in Poland

Taiwan4 sites

  • China Medical University Hospital

    Taichung, 404332

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Hospital

    Tainan, 73657

Other trials in Taiwan

Australia3 sites

  • Canberra Hospital

    Garran, 2605

  • The Perth Blood Institute (PBI)

    West Perth, 6005

  • Westmead Hospital

    Westmead, 2145

Other trials in Australia

Canada3 sites

  • McGill University Health Centre

    Québec, H4A 3J1

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie

    Sherbrooke, Quebec, JIH5N4

  • Eastern Regional Health Authority

    St. John's, Newfoundland and Labrador, A1B3V6

Other trials in Canada

Hungary3 sites

  • Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály

    Budapest, H-1122

  • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika

    Debrecen, H-4032

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz,

    Nyíregyháza, H-4400

Other trials in Hungary

Netherlands2 sites

  • Albert Schweizer Ziekenhuis, Hematology Department

    Dordrecht, 3318

  • Spaarne Gasthuis, Oncology Department

    Hoofddorp, 2134

Other trials in Netherlands

New Zealand2 sites

  • Canterbury District Health Board, Haematology Department

    Christchurch, 8011

  • Dunedin Hospital, Southern Blood and Cancer Service

    Dunedin, 9016

Other trials in New Zealand

About this study

Official title: A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.

Read the detailed description

This is an open label, randomized, two-arm Phase 3 study in subjects with relapsed or refractory FL and MZL to evaluate efficacy and safety of zandelisib in combination with rituximab in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP).

Subjects must have relapsed after at least one previous line of systemic immunochemotherapy. Previous treatments must have included an anti-CD20 monoclonal antibody (mAb) with chemotherapy such as Bendamustine (B), CHOP, CVP, FND, or similar regimens, or an anti-CD20 mAb with Lenalidomide (L).

Approximately 534 randomized subjects will be enrolled in this study.

Being tested
Zandelisib, Rituximab, Bendamustine, CHOP
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.

  • ZandelisibDrug

    Also called ME-401

    Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3

  • RituximabDrug

    Also called Rituxan, MabThera

    Rituximab IV 375 mg/m2 for 6 cycles

  • BendamustineDrug

    Also called Bendeka, Treanda, Belrapzo

    Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles

  • CHOPDrug

    Also called cyclophosphamide 750 mg/m2, hydroxydoxorubicin IV 50 mg/m2, vincristine IV 1.4 mg/m2 and prednisone 100 mg daily

    Cyclophosphamide, Vindcristine IV, and Prednisone daily orally

Study groups in NCT04745832
Study groupRoleWhat they receive
Rituximab plus ZandelisibExperimentalRituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles
Receives: Drug: Zandelisib; Drug: Rituximab
Rituximab plus chemotherapyExperimentalRituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles
Receives: Drug: Rituximab; Drug: Bendamustine; Drug: CHOP

What is being measured

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

  1. Progression Free Survival

    PFS is defined as the time from randomization date until the date of disease progression, or death from any cause

    Measured: 1 year 7 months

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

    ORR is defined as the proportion of subjects who have a best overall response of CR or PR according to the Lugano Classification over the entire duration of the study, including the efficacy follow-up period.

    Measured: 1 year 7 months

  2. Complete Response Rate (CRR)

    CRR is defined as the proportion of subjects who have a best overall response of CR during the study (i.e., up to time of analysis of PFS).

    Measured: 1 year 7 months

  3. Overall Survival

    OS is defined as the time (in days) from randomization until death from any cause. For subjects alive at the time of analysis, they will be censored at the last documented alive date.

    Measured: 1 year 7 months

  4. Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab)

    Measured by the number of Treatment Emergent AEs

    Measured: 1 year 7 months

  5. Number of SAEs (Zandelisib When Combined With Rituximab)

    Measured by the number of SAEs

    Measured: 1 year 7 months

  6. Number of Lab Abnormalities (Zandelisib When Combined With Rituximab)

    Measured by the number of laboratory abnormalities

    Measured: 1 year 7 months

Timeline

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

  1. First posted9 Feb 2021
  2. Study start13 Aug 2021
  3. Primary completion20 Mar 2023
  4. Study completion20 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Arm 1: Rituximab plus Zandelisib Arm 2: Rituximab plus chemotherapy (CHOP or Bendamustine)
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04745832
Sponsor's protocol ID
ME-401-004
Other IDs
2020-004199-16
Status last verified
Dec 2022
First submitted
4 Feb 2021
Last updated
4 Nov 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 3 study testing Zandelisib, Rituximab and Bendamustine in people with Follicular Lymphoma (FL) and Non Hodgkin Lymphoma, run by MEI Pharma, Inc. at 141 sites in 19 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 11 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in Japan, Italy, United States, South Korea, France and 14 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 13 Dec 2023). 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?

Progression Free Survival (time frame: 1 year 7 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 NCT04745832.

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 4 Nov 2024.

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