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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02044276 | A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia | PHASE3 | COMPLETED | 101 | — | — | Mar 31, 2014 | Apr 24, 2018 | Jun 8, 2022 | 60 | Germany, Italy +1 |
Grade 4 neutropenia measured in days
| Arm | Type | Description |
|---|---|---|
| lipegfilgrastim. | EXPERIMENTAL | subcutaneous (SC) injection of 6 mg lipegfilgrastim |
| pegfilgrastim | ACTIVE_COMPARATOR | SC injection of 6 mg pegfilgrastim |
| Name | Type | Description |
|---|---|---|
| lipegfilgrastim | DRUG | 6 mg |
| pegfilgrastim | DRUG | 6 mg |
Inclusion Criteria: 1. Signed and dated Independent Ethics Committee (IEC)-approved written informed consent 2. Age ≥65 years and ≤85 years 3. Histological documentation of aggressive B cell NHL 4. Planned to receive systemic anticancer therapy with at least 6 cycles of R-CHOP-21, according to loca...