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GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL) (ASSIST_FL)

Primary Purpose

Follicular Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GP2013
rituximab
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring Follicular Lymphoma, Biosimilar, GP13-301, rituximab, Antibodies, CD20

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with previously untreated advanced stage, CD20-positive FL
  • Patient with ECOG performance status 0, 1 or 2.

Exclusion Criteria:

  • Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a
  • Patient who has previously received any prior therapy for lymphoma
  • Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal).
  • Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.

Other protocol-defined inclusion/exclusion criteria may apply

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GP2013

rituximab

Arm Description

Type: Biological/Vaccine

Type: Biological/Vaccine

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.

Secondary Outcome Measures

To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
Number of participants with progression free survival events
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths
OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, OS was censored at the date of last contact including survival follow-up.
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
number of participants with confirmed positive ADA
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
C max For descriptive purposes only, no hypothesis testing
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
C through For descriptive purposes only, no hypothesis testing
To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy
AUEC (0-21d) For descriptive purposes only, no hypothesis testing

Full Information

First Posted
August 17, 2011
Last Updated
April 22, 2021
Sponsor
Sandoz
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01419665
Brief Title
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
Acronym
ASSIST_FL
Official Title
A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2011 (Actual)
Primary Completion Date
July 10, 2015 (Actual)
Study Completion Date
January 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
Collaborators
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
Keywords
Follicular Lymphoma, Biosimilar, GP13-301, rituximab, Antibodies, CD20

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A subset of patients is switched from GP2013 to MabThera or continued with MabThera during the maintenance phase, for these patients the treatment is finished as an open labeled parallel arm study. The original treatment assignment is kept blinded.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
629 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GP2013
Arm Type
Experimental
Arm Description
Type: Biological/Vaccine
Arm Title
rituximab
Arm Type
Active Comparator
Arm Description
Type: Biological/Vaccine
Intervention Type
Biological
Intervention Name(s)
GP2013
Other Intervention Name(s)
no brand name available
Intervention Description
Type: Biological/Vaccine
Intervention Type
Biological
Intervention Name(s)
rituximab
Other Intervention Name(s)
MabThera(R)
Intervention Description
Type: Biological/Vaccine
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
Time Frame
24 weeks
Title
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
Time Frame
24 weeks
Title
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
Description
Number of participants with progression free survival events
Time Frame
3 years
Title
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths
Description
OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, OS was censored at the date of last contact including survival follow-up.
Time Frame
3 years
Title
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
Description
number of participants with confirmed positive ADA
Time Frame
24 weeks, 3 years
Title
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
Description
C max For descriptive purposes only, no hypothesis testing
Time Frame
day 63
Title
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
Description
C through For descriptive purposes only, no hypothesis testing
Time Frame
day 63
Title
To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy
Description
AUEC (0-21d) For descriptive purposes only, no hypothesis testing
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with previously untreated advanced stage, CD20-positive FL Patient with ECOG performance status 0, 1 or 2. Exclusion Criteria: Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a Patient who has previously received any prior therapy for lymphoma Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal). Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer. Other protocol-defined inclusion/exclusion criteria may apply
Facility Information:
Facility Name
Investigative site
City
La Plata
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Argentina
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Adelaide
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Australia
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Ballarat
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Australia
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Epping
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Australia
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Footscray
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Australia
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Wodonga
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Australia
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Graz
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Austria
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Wien
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Austria
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Barretos
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Brazil
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Barretos
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Brazil
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Botucatu
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Brazil
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Campinas
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Brazil
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Curitiba
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Brazil
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Florianopolis
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Brazil
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Fortaleza
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Brazil
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Goiania
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Brazil
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Jau
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Brazil
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Sorocaba
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Brazil
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Medellin
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Colombia
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Monteria
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Colombia
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Colmar
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France
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Nimes
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France
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Strasbourg
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France
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Bad Saarow
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Germany
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Koblenz
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Germany
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Athens
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Greece
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Ioannina
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Greece
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Larissa
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Greece
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Patras
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Greece
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Györ
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Hungary
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Kaposvar
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Hungary
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Ahmedabad
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India
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India
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Amritsar
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India
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Aurangabad
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India
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Bangalore
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India
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Chennai
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India
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Hyderabad
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India
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Kolkata
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India
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Kolkata
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Madurai
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India
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Mumbai
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India
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Nashik
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India
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New Delhi
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India
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Pune
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India
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Surat
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India
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Trivandrum
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India
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Vellore
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Dublin
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Ireland
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Limerick
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Ireland
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Waterford
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Ireland
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Ashkelon
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Israel
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Nahariya
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Israel
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Bari
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Italy
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Firenze
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Italy
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Meldola
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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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Pavia
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Italy
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Pescara
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Italy
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Piacenza
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Italy
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Ravenna
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Italy
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Reggio Calabria
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Italy
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Varese
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Italy
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Aomori
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Kagoshima
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Japan
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Kitakyushu
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Japan
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Kobe
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Japan
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Komaki
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Japan
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Matsuyama
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Japan
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Ogaki
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Japan
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Okayama
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Japan
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Omura
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Japan
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Saga
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Japan
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Tachikawa
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Japan
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Ōtake
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Japan
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Alor Setar
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Malaysia
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Ampang
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Malaysia
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George Town
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Malaysia
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Ipoh
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Malaysia
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Johor Bahru
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Malaysia
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Klang
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Malaysia
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Melaka
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Malaysia
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Pulau Pinang
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Malaysia
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Subang Jaya
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Malaysia
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Amsterdam
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Netherlands
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Delft
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Netherlands
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Gouda
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Netherlands
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Heerlen
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Netherlands
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Rotterdam
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Netherlands
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Schiedam
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Netherlands
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Sittard
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Netherlands
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Zwolle
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Netherlands
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Lima
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Peru
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Brzozow
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Poland
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Bydgoszcz
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Poland
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Chorzow
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Warszawa
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Poland
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Braga
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Brasov
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Romania
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Bucharest
Country
Romania
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Cluj-Napoca
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Romania
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Iasi
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Romania
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Timisoara
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Romania
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Arkhangelsk
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Russian Federation
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Investigative site
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Chelyabinsk
Country
Russian Federation
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Investigative site
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Krasnodar
Country
Russian Federation
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Kursk
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Russian Federation
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Moscow
Country
Russian Federation
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Nizhniy Novgorod
Country
Russian Federation
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Rostov-on -Don
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Russian Federation
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St. Petersburg
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Russian Federation
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Cape Town
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South Africa
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George
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South Africa
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Johannesburg
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South Africa
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Port Elizabeth
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South Africa
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Pretoria
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South Africa
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Barcelona
Country
Spain
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Madrid
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Spain
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Oviedo
Country
Spain
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San Sebastian
Country
Spain
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Sevilla
Country
Spain
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Zaragoza
Country
Spain
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Cherkasy
Country
Ukraine
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Investigative site
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Dnipropetrovsk
Country
Ukraine
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Donetsk
Country
Ukraine
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Ivano-Frankivsk
Country
Ukraine
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Kharkiv
Country
Ukraine
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Kyiv
Country
Ukraine
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Lviv
Country
Ukraine
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Eastbourne
Country
United Kingdom
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London
Country
United Kingdom
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Investigative site
City
Worthing
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28712941
Citation
Jurczak W, Moreira I, Kanakasetty GB, Munhoz E, Echeveste MA, Giri P, Castro N, Pereira J, Akria L, Alexeev S, Osmanov E, Zhu P, Alexandrova S, Zubel A, Harlin O, Amersdorffer J. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet Haematol. 2017 Aug;4(8):e350-e361. doi: 10.1016/S2352-3026(17)30106-0. Epub 2017 Jul 14.
Results Reference
derived

Learn more about this trial

GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

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