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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01281917 | Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma | PHASE2 | COMPLETED | 40 | — | — | Feb 1, 2011 | Jun 1, 2014 | Dec 13, 2019 | 18 | United States |
The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy. ORR is the sum of patients with a Complete Response and Partial Response to therapy. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by progression-free survival (PFS).
| Arm | Type | Description |
|---|---|---|
| Velcade plus Temsirolimus | EXPERIMENTAL | Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. |
| Name | Type | Description |
|---|---|---|
| Velcade | DRUG | Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) |
| Temsirolimus | DRUG | Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) |
Inclusion Criteria: * Relapsed or refractory B-cell non-Hodgkin lymphoma which includes: diffuse large B-cell lymphoma; primary mediastinal large B-cell lymphoma; follicular lymphoma (grade 1, 2 or 3); mantle cell lymphoma; small lymphocytic lymphoma; marginal zone lymphoma; lymphoplasmacytic lymph...