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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03814785




Registration number
NCT03814785
Ethics application status
Date submitted
17/08/2011
Date registered
18/08/2011

Titles & IDs
Public title
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
Scientific 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
Secondary ID [1] 0 0
2010-019522-13
Secondary ID [2] 0 0
GP13-301
Universal Trial Number (UTN)
Trial acronym
ASSIST_FL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma 0 0
Arthritis, Psoriatic 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
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GP2013
Treatment: Other - rituximab
Treatment: Drugs - Placebo
Treatment: Drugs - Ustekinumab 45 mg
Treatment: Drugs - Ustekinumab 90 mg

Experimental: GP2013 - Type: Biological/Vaccine

Active comparator: rituximab - Type: Biological/Vaccine

Experimental: Placebo - Participants will receive subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants will cross over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, SC injections of 45 mg ustekinumab will be given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a SC placebo injection will be given at Week 24 to maintain the blind.

Experimental: Ustekinumab 45 mg - Participants will receive SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, SC injections of 90 mg ustekinumab will be given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.

Experimental: Ustekinumab 90 mg - Participants will receive SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, the same dosage schedule will continue. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.


Treatment: Other: GP2013
Type: Biological/Vaccine

Treatment: Other: rituximab
Type: Biological/Vaccine

Treatment: Drugs: Placebo
SC injections

Treatment: Drugs: Ustekinumab 45 mg
SC injections

Treatment: Drugs: Ustekinumab 90 mg
SC injections
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
24 weeks
Primary outcome [2] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.
Timepoint [2] 0 0
Week 24
Secondary outcome [1] 0 0
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
Timepoint [5] 0 0
24 weeks, 3 years
Secondary outcome [6] 0 0
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
Timepoint [6] 0 0
day 63
Secondary outcome [7] 0 0
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
Timepoint [7] 0 0
day 63
Secondary outcome [8] 0 0
To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy
Timepoint [8] 0 0
21 days
Secondary outcome [9] 0 0
Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI)
Timepoint [9] 0 0
Day 1 (Baseline) and Week 24
Secondary outcome [10] 0 0
Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
Timepoint [10] 0 0
Week 24
Secondary outcome [11] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
Timepoint [11] 0 0
Week 24
Secondary outcome [12] 0 0
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24
Timepoint [12] 0 0
Week 24
Secondary outcome [13] 0 0
Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002
Timepoint [13] 0 0
Day 1 (Baseline) and Week 24

Eligibility
Key inclusion criteria
* Patient with previously untreated advanced stage, CD20-positive FL
* Patient with ECOG performance status 0, 1 or 2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/01/2018
Sample size
Target
Accrual to date
Final
629
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigative site - Adelaide
Recruitment hospital [2] 0 0
Investigative site - Ballarat
Recruitment hospital [3] 0 0
Investigative site - Epping
Recruitment hospital [4] 0 0
Investigative site - Footscray
Recruitment hospital [5] 0 0
Investigative site - Wodonga
Recruitment hospital [6] 0 0
- Camperdown
Recruitment hospital [7] 0 0
- Heidelberg
Recruitment hospital [8] 0 0
- Maroochydore
Recruitment hospital [9] 0 0
- Melbourne
Recruitment hospital [10] 0 0
- Perth
Recruitment hospital [11] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Ballarat
Recruitment postcode(s) [3] 0 0
- Epping
Recruitment postcode(s) [4] 0 0
- Footscray
Recruitment postcode(s) [5] 0 0
- Wodonga
Recruitment postcode(s) [6] 0 0
- Camperdown
Recruitment postcode(s) [7] 0 0
- Heidelberg
Recruitment postcode(s) [8] 0 0
- Maroochydore
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment postcode(s) [10] 0 0
- Perth
Recruitment postcode(s) [11] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
Japan
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Nagasaki
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Argentina
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La Plata
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Rosario
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Graz
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Botucatu
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France
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Germany
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Bad Saarow
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Germany
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Koblenz
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Athens
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Larissa
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Greece
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Györ
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Hungary
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Amritsar
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Ashkelon
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Ipoh
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Johor Bahru
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Delft
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Gouda
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Sittard
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Lima
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Brzozow
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Chorzow
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Lublin
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Romania
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Iasi
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Romania
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Rostov-on -Don
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Russian Federation
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Cape Town
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George
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South Africa
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Port Elizabeth
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Pretoria
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Spain
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Sevilla
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Novosibirsk
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Massachusetts
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Minnesota
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Missouri
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Nebraska
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Texas
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Washington
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Innsbruck
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Austria
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Wien N/A
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Alberta
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British Columbia
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New Brunswick
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Newfoundland and Labrador
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Ontario
Country [196] 0 0
Canada
State/province [196] 0 0
Quebec
Country [197] 0 0
Finland
State/province [197] 0 0
Helsinki
Country [198] 0 0
Finland
State/province [198] 0 0
Hyvinkää
Country [199] 0 0
Germany
State/province [199] 0 0
Berlin
Country [200] 0 0
Germany
State/province [200] 0 0
Frankfurt
Country [201] 0 0
Germany
State/province [201] 0 0
Hamburg
Country [202] 0 0
Germany
State/province [202] 0 0
Herne
Country [203] 0 0
Germany
State/province [203] 0 0
Kiel
Country [204] 0 0
Germany
State/province [204] 0 0
Mahlow
Country [205] 0 0
Germany
State/province [205] 0 0
Mainz
Country [206] 0 0
Germany
State/province [206] 0 0
Regensburg
Country [207] 0 0
Germany
State/province [207] 0 0
Tübingen
Country [208] 0 0
Hungary
State/province [208] 0 0
Budapest N/A
Country [209] 0 0
Hungary
State/province [209] 0 0
Budapest
Country [210] 0 0
Hungary
State/province [210] 0 0
Debrecen
Country [211] 0 0
Hungary
State/province [211] 0 0
Kecskemét
Country [212] 0 0
Hungary
State/province [212] 0 0
Szeged
Country [213] 0 0
Hungary
State/province [213] 0 0
Szolnok
Country [214] 0 0
Hungary
State/province [214] 0 0
Veszprém
Country [215] 0 0
Latvia
State/province [215] 0 0
Riga
Country [216] 0 0
Lithuania
State/province [216] 0 0
Alytus
Country [217] 0 0
Lithuania
State/province [217] 0 0
Kaunas
Country [218] 0 0
Lithuania
State/province [218] 0 0
Klaipeda
Country [219] 0 0
Lithuania
State/province [219] 0 0
Siauliai
Country [220] 0 0
New Zealand
State/province [220] 0 0
Christchurch
Country [221] 0 0
New Zealand
State/province [221] 0 0
Rotorua
Country [222] 0 0
New Zealand
State/province [222] 0 0
Wellington
Country [223] 0 0
Poland
State/province [223] 0 0
Bialystok
Country [224] 0 0
Poland
State/province [224] 0 0
Elblag
Country [225] 0 0
Poland
State/province [225] 0 0
Torun
Country [226] 0 0
Russian Federation
State/province [226] 0 0
Ekaterinburg
Country [227] 0 0
Russian Federation
State/province [227] 0 0
Korolev

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sandoz
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novartis Pharmaceuticals
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)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03814785