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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01188681 | Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia | PHASE1 | COMPLETED | 79 | — | — | Sep 1, 2010 | Dec 1, 2014 | Jun 10, 2021 | 25 | United States, Austria +3 |
| NCT00614042 | Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma | PHASE1 | COMPLETED | 96 | — | — | Jan 1, 2008 | Mar 1, 2012 | Jun 28, 2017 | 7 | United States |
Patients had full clinical response assessment monthly during treatment, at the end of treatment (EOT) visit, 30 and 60 days after the EOT visit, and subsequently every 3 months until the earliest of progression of CLL, death, initiation of new therapy, withdrawal from the study, or completion of 18 months of follow-up evaluations. Clinical response assessment included physical examination with measurement of spleen, liver, and lymph nodes, disease-related symptoms, and laboratory measurements, specifically complete blood count (CBC) with differential.
| Arm | Type | Description |
|---|---|---|
| Phase 1: 15 mg/kg TRU-016 + Bendamustine | EXPERIMENTAL | TRU-016 (15 mg/kg) and bendamustine (70 mg/m2), n = 6 patients |
| Phase 1: 20 mg/kg TRU-016 + Bendamustine | EXPERIMENTAL | TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 6 patients |
| Phase 2: TRU-016 and bendamustine | EXPERIMENTAL | TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 32 patients |
| Phase 2: Bendamustine | ACTIVE_COMPARATOR | Bendamustine (70 mg/m2), n = 33 patients |
| 1 | EXPERIMENTAL | Dose escalation and expansion cohorts |
| Name | Type | Description |
|---|---|---|
| TRU-016 and bendamustine | DRUG | TRU-016 at 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles |
| Bendamustine | DRUG | Bendamustine at 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles |
| 15 mg/kg TRU-016 and bendamustine | DRUG | TRU-016 at 15 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles |
| 20 mg/kg TRU-016 and bendamustine | DRUG | TRU-016 at 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles |
| TRU-016 (anti-CD37 protein therapeutic) | DRUG | TRU-016 administered via IV infusion weekly for 8 weeks and then monthly |
Inclusion Criteria: * Diagnosis of relapsed CLL with 1 to 3 prior treatments * Demonstrated active disease requiring treatment * No prior bendamustine treatment * Not refractory to fludarabine or other purines, either as a single agent or in combination * Age \>/=18 years; male or female * Eastern ...