Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03976102 | Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma | PHASE3 | COMPLETED | 317 | — | — | May 15, 2019 | Feb 27, 2023 | Jan 22, 2024 | 4 | United States |
Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR.
| Arm | Type | Description |
|---|---|---|
| Arm A: DRL_RI | EXPERIMENTAL | DRL\_RI (rituximab-Dr. Reddy's Lab) for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36 |
| Arm B: MabThera® | ACTIVE_COMPARATOR | MabThera® for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Week 12, 20, 28 and 36. |
| Name | Type | Description |
|---|---|---|
| DRL_RI (Proposed rituximab biosimilar) | BIOLOGICAL | Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion |
| MabThera® | OTHER | Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion |
Inclusion Criteria: 1. Subject is Male or female subjects aged ≥18 years of age. 2. Subject is histologically confirmed, Grade 1-3a, previous ly untreated, CD20-pos itive. 3. Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1. 4. Subject has Low tumor burden follicular lymphoma as per G...