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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00290511 | Rituximab, Fludarabine, Mitoxantrone, Dexamethasone (R-FND) Plus Zevalin for High-Risk Follicular Lymphoma | PHASE2 | COMPLETED | 49 | — | — | Jun 29, 2004 | Feb 12, 2021 | Apr 22, 2022 | 1 | United States |
Regimen regarded as a success if median TTP can be prolonged to 36 months or greater. Time to Progression measured by the method of Kaplan and Meier, and accompanied by 95% confidence interval. Complete Response (CR) defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays and Partial Response (PR) is defined as a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. av
| Arm | Type | Description |
|---|---|---|
| R-FIND + Zevalin | EXPERIMENTAL | Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. Rituximab 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6. |
| Name | Type | Description |
|---|---|---|
| Fludarabine | DRUG | 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. |
| Mitoxantrone | DRUG | 10 mg/m\^2 IV over 5-30 minutes on Day 2. |
| Rituximab | DRUG | 375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total). |
| Zevalin | DRUG | 0.3 mCi/kg IV after 4 cycles of R-FND. |
| Dexamethasone | DRUG | 20 mg by mouth (PO) or IV daily on Days 2-6. |
Inclusion Criteria: 1. Patients with high-risk Ann Arbor stage III-IV follicular lymphoma. High-risk is defined by advanced stage (III or IV), plus any 2 of the following features: age 60 or greater; elevated LDH; Hgb \< 12; or number of involved nodal sites 5 or more . 2. Patients will be previous...