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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04745832
Ethics application status
Date submitted
4/02/2021
Date registered
9/02/2021

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
Stopped early
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
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Belgium
State/province [10] 0 0
Brugge
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussel
Country [12] 0 0
Belgium
State/province [12] 0 0
Edegem
Country [13] 0 0
Belgium
State/province [13] 0 0
Haine-Saint-Paul
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Canada
State/province [15] 0 0
Newfoundland and Labrador
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Canada
State/province [17] 0 0
Québec
Country [18] 0 0
France
State/province [18] 0 0
Clermont-Ferrand
Country [19] 0 0
France
State/province [19] 0 0
Le Mans
Country [20] 0 0
France
State/province [20] 0 0
Lyon
Country [21] 0 0
France
State/province [21] 0 0
Paris
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France
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Pessac
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France
State/province [23] 0 0
Rouen
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France
State/province [24] 0 0
Tours Cedex 1
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Georgia
State/province [26] 0 0
Tbilisi
Country [27] 0 0
Greece
State/province [27] 0 0
Athens
Country [28] 0 0
Greece
State/province [28] 0 0
Ioánnina
Country [29] 0 0
Greece
State/province [29] 0 0
Patras
Country [30] 0 0
Greece
State/province [30] 0 0
Thessaloníki
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Hungary
State/province [32] 0 0
Debrecen
Country [33] 0 0
Hungary
State/province [33] 0 0
Nyiregyhaza
Country [34] 0 0
Italy
State/province [34] 0 0
Aviano
Country [35] 0 0
Italy
State/province [35] 0 0
Bologna
Country [36] 0 0
Italy
State/province [36] 0 0
Cuneo
Country [37] 0 0
Italy
State/province [37] 0 0
Firenze
Country [38] 0 0
Italy
State/province [38] 0 0
Genova
Country [39] 0 0
Italy
State/province [39] 0 0
Meldola
Country [40] 0 0
Italy
State/province [40] 0 0
Messina
Country [41] 0 0
Italy
State/province [41] 0 0
Mestre
Country [42] 0 0
Italy
State/province [42] 0 0
Milano
Country [43] 0 0
Italy
State/province [43] 0 0
Palermo
Country [44] 0 0
Italy
State/province [44] 0 0
Ravenna
Country [45] 0 0
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
Country [48] 0 0
Japan
State/province [48] 0 0
Aichi
Country [49] 0 0
Japan
State/province [49] 0 0
Ehime
Country [50] 0 0
Japan
State/province [50] 0 0
Fukuoka
Country [51] 0 0
Japan
State/province [51] 0 0
Gunma
Country [52] 0 0
Japan
State/province [52] 0 0
Hyogo
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Japan
State/province [53] 0 0
Kagoshima-Shi, Kagoshima
Country [54] 0 0
Japan
State/province [54] 0 0
Kyoto
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Japan
State/province [55] 0 0
Osaka
Country [56] 0 0
Japan
State/province [56] 0 0
Aomori
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Japan
State/province [57] 0 0
Chiba
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Japan
State/province [58] 0 0
Hiroshima
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Japan
State/province [59] 0 0
Hokkaido
Country [60] 0 0
Japan
State/province [60] 0 0
Kumamoto
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Japan
State/province [61] 0 0
Miyagi
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Japan
State/province [62] 0 0
Nagoya
Country [63] 0 0
Japan
State/province [63] 0 0
Okayama
Country [64] 0 0
Japan
State/province [64] 0 0
Tokyo
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Busan
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Daegu
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Jeollyang
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Seoul
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Ulsan
Country [70] 0 0
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
State/province [77] 0 0
Skorzewo
Country [78] 0 0
Serbia
State/province [78] 0 0
Belgrade
Country [79] 0 0
Serbia
State/province [79] 0 0
Kamenica
Country [80] 0 0
Serbia
State/province [80] 0 0
Kragujevac
Country [81] 0 0
Serbia
State/province [81] 0 0
Novi Sad
Country [82] 0 0
Spain
State/province [82] 0 0
Madrid
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Spain
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Barcelona
Country [84] 0 0
Spain
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Navarro
Country [85] 0 0
Spain
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Santa Cruz De Tenerife
Country [86] 0 0
Spain
State/province [86] 0 0
Sevilla
Country [87] 0 0
Spain
State/province [87] 0 0
Zaragoza
Country [88] 0 0
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
Country [94] 0 0
Turkey
State/province [94] 0 0
Samsun
Country [95] 0 0
Turkey
State/province [95] 0 0
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
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Manchester
Country [101] 0 0
United Kingdom
State/province [101] 0 0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04745832