Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL)
Conditions
Keywords
CLL, NHL, TRU-016, chronic lymphocytic leukemia, non-Hodgkin's lymphoma
Brief summary
The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients with previously treated chronic lymphocytic leukemia, and to obtain an estimate of clinical activity in patients with CLL and non-Hodgkin's lymphoma.
Detailed description
This Phase 1/1b open-label study consists of two parts. The initial portion is a Phase 1 dose-escalation study evaluating the safety and tolerability of TRU-016 administered over a 4-week period to patients with relapsed chronic lymphocytic leukemia (CLL). It will identify the MTD and evaluate the pharmacokinetics and immunogenicity of TRU-016. Upon demonstrating satisfactory safety and tolerability in the Phase 1 portion, a Phase 1b expansion cohort will be enrolled to further characterize the safety of the selected dose from the first stage of the study and safety and to estimate the clinical activity of TRU-016 in patients with treatment-naive CLL, relapsed CLL and non-Hodgkin's lymphoma.
Interventions
DRUGTRU-016 (anti-CD37 protein therapeutic)
TRU-016 administered via IV infusion weekly for 8 weeks and then monthly
Sponsors
Aptevo Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic lymphocytic lymphoma or small lymphocytic lymphoma (Phase 1) or relapsed/refractory NHL (Phase 1b) * Previous treatment with at least one fludarabine-containing regimen * Demonstrate at least one of the following criteria for active disease requiring treatment: * a)progressive splenomegaly and/or lymphadenopathy; * b)anemia or thrombocytopenia due to bone marrow involvement; * c)unintentional weight loss \>10% over preceding 6-month period; * d) NCI Grade 2 or 3 fatigue; * e) fevers \>100.5 F or night sweats for \> 2 weeks without infection; * f) progressive lymphocytosis with increase of \>50% over a 2-month period or anticipated doubling time of \< 6 months. * ECOG performance status \</= 2 * SGOT, SGPT \</= 2.0 x upper limit of normal * ANC \>/= 500/uL * Platelets \>/= 30,000/uL * Discontinued previous anticancer or investigational therapy for at least 30 days
Exclusion criteria
* Treatment with rituximab within 30 days or alemtuzumab(Campath)or radioimmune therapy within 12 weeks * ANC \</= 500/uL * Platelets \</= 30,000/mm3 * Previous or concurrent additional malignancy * Significant concurrent medical diseases or conditions * Hepatitis B surface antigen or hepatitis B core antibody positive * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL | 4 weeks after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary indication of response as defined by NCI 1996 criteria | 3 months after treatment |
Countries
United States
Outcome results
None listed