Clinical trial · Interventional
Phase 1b Safety and Efficacy Study of TRU-016
Phase 1b, Open Label Study to Evaluate Safety and Efficacy of TRU-016 in Combination With Rituximab, Obinutuzumab, Rituximab and Idelalisib, or Ibrutinib in Chronic Lymphocytic Leukemia and With Bendamustine in Peripheral T-cell Lymphoma
NCT01644253CI-TRIAL-00051917terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business decision
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination with rituximab, in combination with obinutuzumab, in combination with rituximab and idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with bendamustine in patients with PTCL.
Conditions
Conditions (2)
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 | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 10 mg/kg TRU-016 + Rituximab | Biological | — | UNRESOLVED |
| 20 mg/kg TRU-016 + Rituximab | Biological | — | UNRESOLVED |
| TRU-016 10-20 mg/kg + bendamustine | Biological | — | UNRESOLVED |
| TRU-016 10-20 mg/kg + ibrutinib | Biological | — | UNRESOLVED |
| TRU-016 20 mg/kg + Obinutuzumab | Biological | — | UNRESOLVED |
| TRU-016 6-20 mg/kg + idelalisib + rituximab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Cohort 1 - Previously Untreated CLL
- description
- 20 mg/kg TRU-016 + Rituximab
- interventionNames
- Biological: 20 mg/kg TRU-016 + Rituximab
- type
- EXPERIMENTAL
- label
- Cohort 2 - Relapsed CLL
- description
- 20 mg/kg TRU-016 + Rituximab
- interventionNames
- Biological: 20 mg/kg TRU-016 + Rituximab
- type
- EXPERIMENTAL
- label
- Cohort 3 - Previously Untreated CLL
- description
- 10 mg/kg TRU-016 + Rituximab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of CLL by 2008 IWCLL criteria and with Rai stage intermediate or high risk CLL. Cohort 8 patients must have a diagnosis of PTCL. * No prior therapy for CLL for Cohorts 1, 3 and 4. For Cohort 2, 1-3 prior treatments. For Cohort 5, patients must have failed to respond or relapsed after 1 or more treatment regimens. For Cohort 6, patients who have been receiving ibrutinib for at least 12 months, have not had a CR, and in whom no cysteine 481 mutation is detected. For Cohort 7, patients who are receiving ibrutinib with stable disease and now have the cysteine 481 mutant clone present at levels of \>1%. For Cohort 8, have refractory or relapsed PTCL after one or more prior therapies. * At least one of the following criteria for active disease requiring treatment: progressive splenomegaly and/or lymphadenopathy; anemia or thrombocytopenia due to bone marrow involvement; or progressive lymphocytosis with an increase of \>50% over a 2-month period or an unanticipated doubling time of less than 6 months * For Cohorts 1, 3 and 4, contraindication to chemotherapy as first-line therapy due to patient age, comorbidity or patient preference * Age \>/= to 18 years * ECOG performance status of \</= 2 * Life expectancy \> 6 months in opinion of Investigator * Serum creatinine, total bilirubin, ALT/SGPT \</= 2.0 x upper limit of normal * ANC \>/= 800/mm3, Cohort 8 (PTCL): ANC \>/= 1000/mm3 * Platelets \>/= 30,000/mm3 Exclusion Criteria: * For Cohorts 1, 3 and 4 only: Has received treatment with rituximab, alemtuzumab, ofatumumab or any other chemotherapeutic agent for CLL. Cohort 8: Received prior treatment with bendamustine and did not respond during treatment or relapsed less than sex months after completing treatment. * Has received an investigational therapy within 30 days of first dose of study drug * Previous or concurrent additional malignancy * Clinically significant pulmonary dysfunction, active infection, prior allogeneic bone marrow transplant, active autoimmune disease * Positive serology for HIV or hepatitis C * Hepatitis B surface antigen or hepatitis B core antibody positive * Pregnant or breastfeeding * Known current drug or alcohol abuse
References
Publications (0)
Data not yet available
No reference posted for this study.