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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04745832




Registration number
NCT04745832
Ethics application status
Date submitted
4/02/2021
Date registered
9/02/2021
Date last updated
13/12/2023

Titles & IDs
Public title
Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
Scientific 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
Secondary ID [1] 0 0
2020-004199-16
Secondary ID [2] 0 0
ME-401-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma (FL) 0 0
Non Hodgkin Lymphoma 0 0
Marginal Zone Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zandelisib
Treatment: Drugs - Rituximab
Treatment: Drugs - Bendamustine
Treatment: Drugs - CHOP

Experimental: Rituximab plus Zandelisib - Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles

Experimental: Rituximab plus chemotherapy - Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles


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

Treatment: Drugs: Rituximab
Rituximab IV 375 mg/m2 for 6 cycles

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

Treatment: Drugs: CHOP
Cyclophosphamide, Vindcristine IV, and Prednisone daily orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
1 year 7 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
1 year 7 months
Secondary outcome [2] 0 0
Complete Response Rate (CRR)
Timepoint [2] 0 0
1 year 7 months
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
1 year 7 months
Secondary outcome [4] 0 0
Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab)
Timepoint [4] 0 0
1 year 7 months
Secondary outcome [5] 0 0
Number of SAEs (Zandelisib When Combined With Rituximab)
Timepoint [5] 0 0
1 year 7 months
Secondary outcome [6] 0 0
Number of Lab Abnormalities (Zandelisib When Combined With Rituximab)
Timepoint [6] 0 0
1 year 7 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/03/2023
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
The Perth Blood Institute (PBI) - West Perth
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
6005 - West Perth
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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Ohio
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United States of America
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Texas
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United States of America
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Utah
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Belgium
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Brugge
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Belgium
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Brussel
Country [12] 0 0
Belgium
State/province [12] 0 0
Edegem
Country [13] 0 0
Belgium
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Haine-Saint-Paul
Country [14] 0 0
Belgium
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Leuven
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Canada
State/province [15] 0 0
Newfoundland and Labrador
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Canada
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Quebec
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Canada
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Québec
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France
State/province [18] 0 0
Clermont-Ferrand
Country [19] 0 0
France
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Le Mans
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France
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Lyon
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France
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Paris
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France
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Pessac
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France
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Rouen
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France
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Tours Cedex 1
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France
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Villejuif
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Georgia
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Tbilisi
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Greece
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Athens
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Greece
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Ioánnina
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Greece
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Patras
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Greece
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Thessaloníki
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Nyiregyhaza
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Italy
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Aviano
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Italy
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Bologna
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Italy
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Cuneo
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Italy
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Firenze
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Italy
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Genova
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Italy
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Meldola
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Italy
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Messina
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Italy
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Mestre
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Italy
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Milano
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Italy
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Palermo
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Italy
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Ravenna
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Italy
State/province [45] 0 0
Rimini
Country [46] 0 0
Italy
State/province [46] 0 0
Roma
Country [47] 0 0
Italy
State/province [47] 0 0
Terni
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Japan
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Aichi
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Japan
State/province [49] 0 0
Ehime
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Japan
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Fukuoka
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Japan
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Gunma
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Japan
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Hyogo
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Japan
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Kagoshima-Shi, Kagoshima
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Japan
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Kyoto
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Japan
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Osaka
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Hiroshima
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Japan
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Hokkaido
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Kumamoto
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Miyagi
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Japan
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Nagoya
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Japan
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Okayama
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Japan
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Tokyo
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Jeollyang
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Korea, Republic of
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Seoul
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Korea, Republic of
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Ulsan
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Netherlands
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Dordrecht
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Netherlands
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Hoofddorp
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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Poland
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Bydgoszcz
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Poland
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Kraków
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Poland
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Pila
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Poland
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Skorzewo
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Serbia
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Belgrade
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Serbia
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Kamenica
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Serbia
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Kragujevac
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Serbia
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Novi Sad
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Spain
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Madrid
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Spain
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Barcelona
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Spain
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Navarro
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Spain
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Santa Cruz De Tenerife
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Spain
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Sevilla
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Spain
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Zaragoza
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Taiwan
State/province [88] 0 0
Taichung
Country [89] 0 0
Taiwan
State/province [89] 0 0
Tainan City
Country [90] 0 0
Taiwan
State/province [90] 0 0
Tainan
Country [91] 0 0
Turkey
State/province [91] 0 0
Ankara
Country [92] 0 0
Turkey
State/province [92] 0 0
Istanbul
Country [93] 0 0
Turkey
State/province [93] 0 0
Kayseri
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Turkey
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Samsun
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Turkey
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Tekirdag
Country [96] 0 0
Turkey
State/province [96] 0 0
Trabzon
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Denbighshire
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Cornwell
Country [99] 0 0
United Kingdom
State/province [99] 0 0
London
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United Kingdom
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Manchester
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United Kingdom
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Oxford
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Plymouth
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Surrey Quays

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MEI Pharma, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Kyowa Kirin, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 3 study of the PI3Kd 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04745832
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04745832