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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04745832
Other study ID # ME-401-004
Secondary ID 2020-004199-16
Status Terminated
Phase Phase 3
First received
Last updated
Start date August 13, 2021
Est. completion date March 20, 2023

Study information

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

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 82
Est. completion date March 20, 2023
Est. primary completion date March 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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: 1. FL Gr 1, Gr 2, or Gr 3a 2. 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 - 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 Exclusion Criteria: - 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 - 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

Study Design


Intervention

Drug:
Zandelisib
Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3
Rituximab
Rituximab IV 375 mg/m2 for 6 cycles
Bendamustine
Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles
CHOP
Cyclophosphamide, Vindcristine IV, and Prednisone daily orally

Locations

Country Name City State
Australia Canberra Hospital Garran
Australia The Perth Blood Institute (PBI) West Perth
Australia Westmead Hospital Westmead
Belgium AZ Sint-Jan Burgge-Oostende AV Brugge
Belgium UZ Brussel Brussel
Belgium Universitair Ziekenhuis Antwerpen Edegem
Belgium Center Hospitalier de Jolimont Haine-Saint-Paul
Belgium UZ Leuven Campus Gasthuisberg Leuven
Canada McGill University Health Centre Québec
Canada Eastern Regional Health Authority Saint John's Newfoundland and Labrador
Canada Centre intégré universitaire de santé et de services sociaux de l'Estrie Sherbrooke Quebec
France CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte, Clermont-Ferrand
France Centre Hospitalier De Dunkerque - Service d'hématologie Le Mans
France Centre Hospitalier du Mans Le Mans
France Centre Leon Berard Lyon
France Hôpital Saint-Louis Paris
France CHU de Bordeaux - Maladies Du Sang, Centre François Magendie Pessac
France Centre Henri Becquerel, Service d'Hematologie Rouen
France CHU de Tours, Hôpital Bretonneau Centre Tours Cedex 1
France Institut De Cancerologie Gustave Roussy Villejuif
Georgia J.S.C. K. Eristavi National Center of Experimental and Clinic Tbilisi
Georgia LTD "Medinvest" Institute of Hematology and Transfusiology Tbilisi
Georgia LTD Israeli-Georgian Medical Research Clinic "Helsicore" Tbilisi
Georgia M. Zodelava Hematology Center Tbilisi
Greece General Hospital of Athens "Laiko", Department of Haematology and Bone Marrow Transplantation Athens
Greece University General Hospital of Ioannina, Department of Haematology Ioánnina
Greece University General Hospital of Patras "Panagia H. Voitheia" Patras
Greece General Hospital of Thessaloniki "G. Papanikolaou" Thessaloníki
Hungary Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály Budapest
Hungary Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika Debrecen
Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Nyiregyhaza
Italy SOC Oncologia Medica e dei Tumori Immunocorrelati Aviano
Italy UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi Bologna
Italy U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle Cuneo
Italy U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi Firenze
Italy U.O. Clinica Ematologica Genova
Italy SC Oncologia Medica Meldola
Italy UOC Ematologia, Presidio Ospedaliero Papardo Messina
Italy UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre Mestre
Italy Dipartimento di Oncoematologia, Unità Linfomi, Ospedale Milano
Italy Divisione Oncoematologia, Istituto Europeo di Oncologia Milano
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Milano
Italy Azienda Ospedaliera Ospedali Riuniti Via Sofia Palermo
Italy UO Ematologia, Ospedale Civile S.Maria delle Croci Ravenna
Italy UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna Rimini
Italy Istituti Fisioterapici Ospitalieri Roma
Italy S.C. Oncoematologia Azienda Ospedaliera Santa Maria Terni
Japan Anjo Kosei Hospital Aichi
Japan Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital Aichi
Japan Aomori Prefectural Central Hospital Aomori
Japan Chiba Cancer Center Chiba
Japan Kyushu University Hospital Fukuoka
Japan Chugoku Central Hospital Hiroshima
Japan Hokkaido University Hospital Hokkaido
Japan University Hospital Kyoto Prefectural University of Medicine Kamigyo-ku Kyoto
Japan Kobe City Medical Center General Hospital Kobe Hyogo
Japan National Hospital Organization Kumamoto Medical Center Kumamoto
Japan Kyoto University Hospital Kyoto
Japan Gunma University Hospital Maebashi Gunma
Japan National Hospital Organization Shikoku Cancer Center Matsuyama-Shi Ehime
Japan National Hospital Organization Kyushu Cancer Center Minami Fukuoka
Japan National University Corporation Tohoku University Hospital Miyagi
Japan Aichi Cancer Center Hospital Nagoya
Japan National Hospital Organization Nagoya Medical Center Naka-ku Aichi
Japan Okayama University Hospital Okayama
Japan Osaka International Cancer Institute Osaka
Japan Osaka University Hospital Osaka
Japan Kindai University Hospital Osakasayama-shi Osaka
Japan Kagoshima University Hospital Sakuragaoka Kagoshima-Shi, Kagoshima
Japan Keio University Hospital Tokyo
Japan The Cancer Institute Hospital of Japanese Foundation For Cancer Research Tokyo
Japan Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo
Korea, Republic of Dong-A university Hospital Busan
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Chonnam National University Hwasun Hospital Jeollyang
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Ewka 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 Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul
Korea, Republic of Ulsan University Hospital Ulsan
Netherlands Albert Schweizer Ziekenhuis, Hematology Department Dordrecht
Netherlands Spaarne Gasthuis, Oncology Department Hoofddorp
New Zealand Canterbury District Health Board, Haematology Department Christchurch
New Zealand Dunedin Hospital, Southern Blood and Cancer Service Dunedin
Poland Klinika Hematologii, Szpital Uniwersytecki Bydgoszcz
Poland Pratia MCM Krakow Kraków
Poland ARS Medical - Szpital, Oddzial hematologiczny Pila
Poland Centrum Medyczne Pratia Poznan Skorzewo
Serbia Clinical Hospital Center "Zemun", Clinic for Internal Medicine, Department for Hematology Belgrade
Serbia University Clinical Center of Serbia, Clinic for Hematology Belgrade
Serbia Zvezdara University Medical Center, Clinical department for Hematology and Oncology Belgrade
Serbia Oncology Institute of Vojvodina, Clinic for Internal Oncology Kamenica
Serbia University Clinical Center Kragujevac, Clinic for Hematology Kragujevac
Serbia Clinical Center of Vojvodina, Clinic for Hematology Novi Sad
Spain Hospital Universitario Quironsalud Alcorcón Madrid
Spain Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology Barcelona
Spain Hospital Universitario Mútua Terrassa Barcelona
Spain Institut Catalá d'Oncologia, Hospital Duran i Reynals Barcelona
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Complejo Hospitalario de Navarra Navarro
Spain Hospital Universitario de Canarias Santa Cruz De Tenerife
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Universitario Miguel Servet Zaragoza
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Chi Mei Hospital Tainan City
Turkey Gazi University Health Research and Application Hospital, Hematology Department Ankara
Turkey Istanbul University Istanbul Medical Faculty, Hematology Department Istanbul
Turkey Erciyes University Medical Faculty, Department of Hematology Kayseri
Turkey Ondokuz Mayis University Medical Faculty, Hematology Department Samsun
Turkey Namik Kemal University Hospital Tekirdag
Turkey Karadeniz Technical University Medical Faculty Department of Hematology Trabzon
United Kingdom North Wales Cancer Treatment Centre Bodelwyddan Denbighshire
United Kingdom Royal Cornwall Hospital Cornwell
United Kingdom Department of Haematology St. George's University of London London
United Kingdom Imperial College Healthcare NHS Trust Hammersmith Hospital London
United Kingdom The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital London
United Kingdom The Christie NHS Foundation Trust Manchester
United Kingdom Genesis Care Oxford Oxford
United Kingdom University Hospitals Plymouth NHS Trust, Derriford Hopital Plymouth
United Kingdom The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital Surrey Quays
United States Alpha Research Institute, LLC Baytown Texas
United States MetroHealth Medical Center Cleveland Ohio
United States Henry Ford Hospital Detroit Michigan
United States Revive Research Institute Farmington Hills Michigan
United States Orange Coast Memorial Medical Center Fountain Valley California
United States Valley Cancer Associates Harlingen Texas
United States BRCR Medical Center Inc Hollywood Florida
United States Long Beach Memorial Medical Center Long Beach California
United States Inspira Medical Center Mullica Hill Mullica Hill New Jersey
United States Community Cancer Trials of Utah Ogden Utah
United States The Oncology Institute of Hope and Innovation Riverside California
United States Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center Springfield Missouri
United States Revive Research Institute Sterling Heights Michigan
United States The Oncology Institute of Hope and Innovation Tucson Arizona

Sponsors (2)

Lead Sponsor Collaborator
MEI Pharma, Inc. Kyowa Kirin, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Georgia,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Serbia,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival PFS is defined as the time from randomization date until the date of disease progression, or death from any cause 1 year 7 months
Secondary 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. 1 year 7 months
Secondary 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). 1 year 7 months
Secondary 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. 1 year 7 months
Secondary Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab) Measured by the number of Treatment Emergent AEs 1 year 7 months
Secondary Number of SAEs (Zandelisib When Combined With Rituximab) Measured by the number of SAEs 1 year 7 months
Secondary Number of Lab Abnormalities (Zandelisib When Combined With Rituximab) Measured by the number of laboratory abnormalities 1 year 7 months
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