A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Lymphoma, Follicular
- Sponsor
- Archigen Biotech Limited
- Enrollment
- 315
- Locations
- 3
- Primary Endpoint
- Overall Response Rate (ORR) at Week 28
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma.
Detailed Description
This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma. Patients will be randomized in a 1:1 ratio to receive study drug once a week for 4 weeks, and will then be followed up for up to 52 weeks after the first dose. Randomization will be stratified by inclusion in the PK/PD sub-population and Follicular lymphoma international prognostic index 2 (FLIPI-2) score. Visits are scheduled at Weeks 1, 2, 3, and 4 (study drug infusion visits), and then at Weeks 5, 12, 20, 28, 36, and 52 (i.e., End of Study \[EOS\]). Efficacy response assessments will be performed at Weeks 12 and 28, while safety assessments will continue until end of Study (EOS). The primary objectives is to compare the efficacy of SAIT101 with rituximab licensed in the European Union (hereafter designated MabThera®, brand name in EU) when administered as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTBFL) and the secondary objectives is to evaluate SAIT101 versus MabThera® with respect to safety and tolerability, immunogenicity and Pharmacokinetics (PK)/Pharmacodynamics (PD) in a sub-population of patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with histologically-confirmed Low Tumor Burden Follicular Lymphoma, without B symptoms, Ann Arbor stage II to Non-Hodgkin's Lymphoma (NHL) (CD20+ Follicular Lymphoma of Grades 1, 2, or 3a)
- •Low tumor burden according to The Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria defined as:
- •Normal serum lactate dehydrogenase (LDH)
- •No mass ≥7 cm.
- •Less than 3 nodal sites, each with diameter \>3 cm
- •No systemic or B symptoms (fever \>38°C for 3 consecutive days; recurrent, drenching night sweats; unintentional weight loss exceeding 10% body weight in the last 6 months.
- •No splenomegaly ≥16 cm by CT scan.
- •No risk of vital organ compression.
- •No pleural or peritoneal serous effusion.
- •No leukemic phase \>5,000/µL circulating tumor cells.
Exclusion Criteria
- •Previous treatment with any chemotherapy and/or rituximab or other monoclonal antibody.
- •Prior radiotherapy completed \<28 days before study enrollment.
- •Anticipated need for concomitant administration of any other experimental drug, or a concomitant chemotherapy, anticancer hormonal therapy, radiotherapy, or immunotherapy during study participation.
- •Concomitant disease which requires continuous therapy with corticosteroids at doses equivalent to prednisolone \>20 mg/day.
- •Transformation to high-grade lymphoma secondary to previously untreated low-grade lymphoma.
- •Prior or concomitant malignancies within 5 years prior to screening, with the exceptions of non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, adequately treated breast cancer in situ, and localized prostate cancer stage T1c, provided that the patient underwent curative treatment and remains relapse free.
- •Patients with a body surface area \>3.0 m
- •Major surgery (excluding lymph node biopsy) within 28 days prior to randomization.
- •Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus (HIV) infection or positive test at screening.
- •Acute, severe infection (e.g., sepsis and opportunistic infections), or active, chronic or persistent infection that might worsen with immunosuppressive treatment (e.g., herpes zoster).
Outcomes
Primary Outcomes
Overall Response Rate (ORR) at Week 28
Time Frame: Baseline (Day 0) to Week 28.
Overall Response Rate (ORR) (Complete Response \[CR\] + Partial Response \[PR\]) at Week 28, as defined by International Working Group (IWG) criteria 2007. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007. The 95% CI for overall response rate (ORR) was calculated using the Exact method and combined using the Rubin's rule when multiple imputation was applicable.
Secondary Outcomes
- Overall Response Rate (ORR) at Week 12(Baseline (Day 0) to Week 12)
- Complete Response (CR) at Weeks 12 and 28(Baseline (Day 0) to Week 12 and Week 28.)
- Partial Response (PR) at Weeks 12 and 28(Baseline (Day 0) to Week 12 and Week 28.)
- Stable Disease (SD) at Weeks 12 and 28(Baseline (Day 0) to Week 12 and Week 28.)
- Progressive Disease (PD) at 12 and 28 Weeks(Baseline (Week 0)to Week 12 and Week 28.)
- Time to Event (TTE)(Baseline (Day 0) to time of event or up to a maximum of 32 weeks, whichever is sooner)