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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00722137 | Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma | PHASE3 | COMPLETED | 487 | — | — | May 1, 2008 | Jun 17, 2017 | Jul 12, 2018 | 150 | United States, Austria +27 |
PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee.
| Arm | Type | Description |
|---|---|---|
| R-CHOP | ACTIVE_COMPARATOR | Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, Vincristine 1.4 mg/m\^2, and Prednisone 100 mg/m\^2 |
| VcR-CAP | EXPERIMENTAL | Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, VELCADE 1.3 mg/m\^2, and Prednisone 100 mg/m\^2 |
| Name | Type | Description |
|---|---|---|
| Rituximab 375 mg/m^2 | DRUG | Intravenous rituximab 375 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles. |
| Cyclophosphamide 750 mg/m^2 | DRUG | Intravenous cyclophosphamide 750 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles |
| Doxorubicin 50 mg/m^2 | DRUG | Intravenous doxorubicin 50 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles |
| VELCADE 1.3 mg/m^2 | DRUG | Intravenous VELCADE 1.3 mg/m\^2 on Days 1,4,8, and 11of a 21-day (3 week) cycle for 6 cycles |
| Prednisone 100 mg/m^2 | DRUG | Oral prednisone 100 mg/m\^2 on Day 1 to Day 5 of a 21-day (3 week) cycle for 6 cycles |
| Vincristine 1.4 mg/m^2 | DRUG | Intravenous vincristine 1.4 mg/m\^2 on Day 1of a 21-day (3 week) cycle for 6 cycles. Maximum of 2 mg. Participants could receive 8 cycles if a response was initially documented at the Cycle 6 assessment. |
Inclusion Criteria: * Male or female patients 18 years or older (the patient must be at least the legal age limit to be able to give informed consent within the jurisdiction the study is taking place) * Diagnosis of mantle cell lymphoma MCL (Stage II, III or IV) as evidenced by lymph node histology...