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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00493467 | Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas | PHASE2 | COMPLETED | 31 | — | — | Jun 1, 2006 | Aug 11, 2022 | Sep 15, 2022 | 1 | United States |
ORR defined as the percentage of number of complete response (CR), complete response unconfirmed (CRu) or partial response (PR) in patients treated using International Working Group (IWG) revised response criteria for Malignant Lymphoma. ORR to therapy is evaluated after three months using radiographic and clinical parameters to assess response. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. CRu: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameters (SPD). Individual nodes that were previously confluent must have regressed by more than 75% in their SPD compared to the original mass and indeterminate bone marrow. PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses. No increase in the size of other nodes, liver or spleen and no new sites of disease.
| Arm | Type | Description |
|---|---|---|
| Zevalin | EXPERIMENTAL | Ibritumomab Tiuxetan (Zevalin) + Rituximab |
| Name | Type | Description |
|---|---|---|
| Ibritumomab Tiuxetan (Zevalin) | DRUG | 111In Zevalin (5 mCi of \^111In, 1.6 mg of Ibritumomab Tiuxetan) Intravenously Over 10 minutes on Day 1. 90Y Zevalin 0.3 or 0.4 mCi/kg Intravenously Over 10 minutes on Day 8. |
| Rituximab | DRUG | 250 mg/m\^2 Intravenously Over 4-6 Hours On Days 1 and 8. |
Inclusion Criteria: 1. New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin lesions will be eligible provided that the skin is the only site of involvement. 2. Histology includes Indolent cluster of differentiation antigen 20 (CD20)+ lymphomas including: Follicular ...