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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Lymphocytic Leukemia (CLL) Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin's Lymphoma (NHL) Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding sites for this trial call 919-319-9374, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRU-016 (anti-CD37 protein therapeutic)

Drug

TRU-016 administered via IV infusion weekly for 8 weeks and then monthly

Primary outcomes

Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL

Time frame: 4 weeks after treatment

Secondary outcomes

Preliminary indication of response as defined by NCI 1996 criteria

Time frame: 3 months after treatment

Sponsors and collaborators

Lead sponsor

Aptevo Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2012
First posted: Feb 13, 2008
Registry last updated: Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed