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Also known as TRU-016 (anti-CD37 protein therapeutic), otlertuzumab
TRU-016 · 3 trials · 3 indications
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.
Response was assessed by the investigator on the basis of clinical, radiological, and pathological (i.e., bone marrow) criteria, using the IWG criteria (Cheson et al 2007). A CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
| 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 |
| TRU-016+bendamustine+rituximab | EXPERIMENTAL | Two dose levels (10 and 20 mg/kg) of TRU 016 combined with rituximab 375 mg/m2 and bendamustine 90 mg/m2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles. |
| 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 | DRUG | 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle |
| Rituximab | DRUG | Rituximab by IV administration at 375 mg/m\^2 on Day 2 of each 28 day cycle. |
| 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 ...
TRU-016 and bendamustine refers to a combination treatment studied in B-cell blood cancers, pairing the investigational agent TRU-016 with the chemotherapy drug bendamustine. It was evaluated in relapsed chronic lymphocytic leukemia and recurrent B-cell small lymphocytic lymphoma. The combination was tested in Phase 1 clinical trials sponsored by Aptevo Therapeutics Inc. (APVO).
TRU-016 and bendamustine was studied for treating relapsed chronic lymphocytic leukemia (CLL) and recurrent B-cell small lymphocytic lymphoma. These are hematologic malignancies affecting B cells. The combination was investigated in patients who had previously received treatment for their disease.
Aptevo Therapeutics Inc., which trades under the ticker APVO, is the developer of TRU-016 and the combination regimen with bendamustine. The company sponsored the Phase 1 clinical trials evaluating this combination in relapsed CLL and recurrent B-cell small lymphocytic lymphoma.
TRU-016 and bendamustine has been studied in Phase 1 clinical trials. All three registered studies of TRU-016, including the combination with bendamustine, are listed as completed, and no trials are currently active. The regimen remains investigational and is not approved for commercial use.
Two Phase 1 trials evaluated TRU-016 with bendamustine. NCT01188681 tested TRU-016 plus bendamustine versus bendamustine alone in relapsed CLL across the United States, Austria, Germany, Poland, and Spain, enrolling 79 patients. NCT01317901 studied TRU-016 with rituximab and bendamustine in relapsed indolent lymphoma in the United States, enrolling 12 patients. Both are completed.