Phase 3
N=627
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01419665 ↗Enrolled (actual)
627
Serious AEs
15.8%
Results posted
May 2021
Primary outcome: Primary: Overall Response Rate (ORR) — 87.1; 87.5 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GP2013 (Biological); rituximab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sandoz
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
87.1; 87.5 | — |
| SECONDARY To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period |
46; 42 | — |
| SECONDARY To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period |
225; 232 | — |
| SECONDARY To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization |
97; 78 | — |
| SECONDARY To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths |
29; 31 | — |
| SECONDARY To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab) |
1; 2; 1; 0 | — |
| SECONDARY To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max) |
333.59; 331.93 | — |
| SECONDARY To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough) |
66.42; 82.13 | — |
| SECONDARY To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy |
1790; 1910 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01419665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.