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

June 26, 2017 updated by: Aptevo Therapeutics

A Phase 1/1b Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • For additional information regarding sites for this trial call 919-319-9374
    • Georgia
      • Augusta, Georgia, United States, 30912
        • For additional information regarding sites for this trial call 919-319-9374
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • For additional information regarding sites for this trial call 919-319-9374
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • For additional information regarding sites for this trial call 919-319-9374
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • For additional information regarding sites for this trial call 919-319-9374
    • Oregon
      • Portland, Oregon, United States, 97239
        • For additional information regarding sites for this trial call 919-319-9374
    • Washington
      • Seattle, Washington, United States, 98109
        • For additional information regarding sites for this trial call 919-319-9374

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aptevo Therapeutics

Investigators

  • Study Director: Scott Stromatt, MD, Aptevo Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

January 25, 2008

First Submitted That Met QC Criteria

January 31, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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