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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03283202 | Study of Safety and Efficacy of Avadomide (CC-122) Combined With RCHOP for Newly-diagnosed DLBCL With Poor Risk Factors | PHASE1 | COMPLETED | 35 | — | — | Oct 4, 2017 | Dec 16, 2020 | Apr 29, 2021 | 15 | United States, Belgium +2 |
Frequency of dose-limiting toxicities (DLTs) associated with the addition of avadomide (CC-122) to R-CHOP-21 therapy
CR is defined as target nodes/nodal masses regress to ≤ 1.5 cm in LDi; no extralymphatic sites of disease; no measurable lesions, no organ enlargement and normal morphology on bone marrow (BM) exam; immunohistochemically (IHC) negative
| Arm | Type | Description |
|---|---|---|
| Avadomide (CC-122) plus R-CHOP-21 | EXPERIMENTAL | Avadomide (CC-122) by mouth (PO) at varying dose levels (Ph 1) on Days 1 through 5 and Days 8 through 12 plus Rituxan 375 mg/m2 by intravenous (IV) infusion, cyclophosphamide 750mg/m2 by IV infusion, doxorubicin 50 mg/m2 IV, vincristine 1.4 mg/m2 (max is 2.0 mg) IV and 100 mg PO prednisone/prednisolone on Days 1 through 5 of each 21-day treatment cycles for up to 6 total treatment cycles (approximately 18 weeks or 4 months) |
| Name | Type | Description |
|---|---|---|
| Avadomide (CC-122) | DRUG | Avadomide (CC-122) by mouth at the assigned dose in Ph 1 starting on Day 1 for 5 consecutive days per week, followed by 2 days without avadomide (CC-122) administration (5/7) for the first two weeks of a 21-day treatment cycle. If the highest proposed dose level to be explored in Phase 1 is applied, the dosing regimen will be 5/7 days for all 3 weeks of each 21-day treatment cycle. |
| Rituximab | DRUG | Rituxan 375 mg/m2 on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles |
| Cyclophosphamide 750mg/m2 by IV infusion | DRUG | Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles |
| Vincristine | DRUG | Vincristine 1.4 mg/m2 (maximum of 2.0 mg total) on Day 1 by IV bolus on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles |
| Prednisone | DRUG | Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles |
Inclusion Criteria: 1\. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2\. Subject has documented, histologically locally confirmed, previously untreated CD20+ DLBCL (NOS) and the following histologies; refer to the World Health Organization (WHO) 2016 classif...