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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00038623 | Study Of Yttrium-ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma | PHASE2 | COMPLETED | 35 | — | — | Apr 1, 2002 | Feb 1, 2010 | Nov 2, 2011 | 1 | United States |
Objective tumor response is defined as CR + CCR + PR, where CR = Complete Response, CCR = Clinical Complete Response and PR = partial response. All patients who receive any dose of Zevalin will be included in the calculation of response rate.
| Arm | Type | Description |
|---|---|---|
| Yttrium-ibritumomab (Zevalin) | EXPERIMENTAL | After Rituximab infusion (250 mg/m\^2 intravenous) on Day 1, 111\^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2. |
| Name | Type | Description |
|---|---|---|
| Yttrium-ibritumomab (Zevalin) | DRUG | After Rituximab infusion, 111\^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2. |
| Rituximab | DRUG | 250 mg/m\^2 in the vein over 6 to 8 hours on Day 1. |
Inclusion Criteria: 1. Histologically confirmed, relapsed or refractory mantle cell lymphoma requiring treatment. 2. No anti-cancer therapy for three weeks (6 weeks if rituximab, nitrosurea, or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior sur...