Clinical trial · Interventional
Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia
A Phase 1b/2 Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination With Bendamustine vs. Bendamustine Alone in Patients With Relapsed Chronic Lymphocytic Leukemia
NCT01188681CI-TRIAL-00052208completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of the first part of the study is to determine a safe dose of TRU-016 that can be used in combination with bendamustine in patients with relapsed CLL. The objectives of the second part of the study are to compare the safety and efficacy of TRU-016 in combination with bendamustine to bendamustine alone in patients with relapsed CLL.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 15 mg/kg TRU-016 and bendamustine | Drug | — | UNRESOLVED |
| 20 mg/kg TRU-016 and bendamustine | Drug | — | UNRESOLVED |
| Bendamustine | Drug | Bendamustine | ALIAS |
| TRU-016 and bendamustine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 1: 15 mg/kg TRU-016 + Bendamustine
- description
- TRU-016 (15 mg/kg) and bendamustine (70 mg/m2), n = 6 patients
- interventionNames
- Drug: 15 mg/kg TRU-016 and bendamustine
- type
- EXPERIMENTAL
- label
- Phase 1: 20 mg/kg TRU-016 + Bendamustine
- description
- TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 6 patients
- interventionNames
- Drug: 20 mg/kg TRU-016 and bendamustine
- type
- EXPERIMENTAL
- label
- Phase 2: TRU-016 and bendamustine
- description
- TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 32 patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 Cooperative Oncology Group (ECOG) performance status of \</= 2 * Creatinine clearance \> 40 mL/min * Absolute neutrophil count (ANC) \>/= 1,200/mm3 * Platelets \>/= 75,000/mm3 * Lymphocytes \>/= 5,000/mm3 in Phase 1b Exclusion Criteria: * Treatment with rituximab or other B-cell depleting agent within 30 days or alemtuzumab within 12 weeks * Previous anticancer therapy within 30 days * Refractory to prior fludarabine or other purine analog therapy either as a single agent or in combination * Receipt of prior bendamustine or TRU-016 * Receipt of an investigational therapy or major surgery within 30 days * Previous or concurrent additional malignancy (some exceptions apply) * Any significant concurrent medical diseases or conditions * Positive serology for HIV or hepatitis C, hepatitis B surface antigen positive or hepatitis B core antibody positive. * Pregnant or breast feeding * Drug or alcohol abuse * Allergic to mannitol
References
Publications (1)
- BACKGROUNDRobak T, Hellmann A, Kloczko J, Loscertales J, Lech-Maranda E, Pagel JM, Mato A, Byrd JC, Awan FT, Hebart H, Garcia-Marco JA, Hill BT, Hallek M, Eisenfeld AJ, Stromatt SC, Jaeger U. Randomized phase 2 study of otlertuzumab and bendamustine versus bendamustine in patients with relapsed chronic lymphocytic leukaemia. Br J Haematol. 2017 Feb;176(4):618-628. doi: 10.1111/bjh.14464. Epub 2016 Dec 15. PMID 27977057