Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma

Study Overview
=================
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.

Official Title
-----------------
A Phase 1/1b Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia or Select Subtypes of Non-Hodgkin's Lymphoma

Conditions
-----------------
Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL)

Intervention / Treatment
-----------------
* Drug: TRU-016 (anti-CD37 protein therapeutic)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose escalation and expansion cohorts | Drug: TRU-016 (anti-CD37 protein therapeutic)<br>* TRU-016 administered via IV infusion weekly for 8 weeks and then monthly<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL |  | 4 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary indication of response as defined by NCI 1996 criteria |  | 3 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL, NHL, TRU-016, chronic lymphocytic leukemia, non-Hodgkin's lymphoma