Status:
COMPLETED
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
Lead Sponsor:
Sandoz
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Patient with previously untreated advanced stage, CD20-positive FL
- Patient with ECOG performance status 0, 1 or 2.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2018
Estimated Enrollment :
629 Patients enrolled
Trial Details
Trial ID
NCT01419665
Start Date
December 1 2011
End Date
January 22 2018
Last Update
May 14 2021
Active Locations (153)
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1
Investigative site
La Plata, Argentina
2
Investigative site
Rosario, Argentina
3
Investigative site
San Miguel de Tucumán, Argentina
4
Investigative site
Adelaide, Australia