Phase 2
Completed N=79
Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov NCT01188681 ↗Enrolled (actual)
79
Serious AEs
37.7%
Results posted
Jan 2017
Primary outcomePrimary: Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria — 66.7; 83.3; 68.8; 39.4 percentage of patients
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria |
66.7; 83.3; 68.8; 39.4 | — |
| SECONDARY Response Per NCI Criteria |
81.3; 66.7; 66.7; 100 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01188681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.