Clinical trial · Interventional
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
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
NCT01419665CI-TRIAL-00051807ASSIST_FLcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GP2013
- description
- Type: Biological/Vaccine
- interventionNames
- Biological: GP2013
- type
- ACTIVE_COMPARATOR
- label
- rituximab
- description
- Type: Biological/Vaccine
- interventionNames
- Biological: rituximab
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 24 weeks
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJurczak 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. PMID 28712941