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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Chronic Lymphocytic Leukemia (CLL); Non-Hodgkin's Lymphoma (NHL)	Drug: TRU-016 (anti-CD37 protein therapeutic)	Phase 1

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	96 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	January 2008
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	March 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL [ Time Frame: 4 weeks after treatment ]

Secondary Outcome Measures :

1. Preliminary indication of response as defined by NCI 1996 criteria [ Time Frame: 3 months after treatment ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Aptevo Therapeutics

Investigators

Study Director:	Scott Stromatt, MD	Aptevo Therapeutics

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Pagel JM, Spurgeon SE, Byrd JC, Awan FT, Flinn IW, Lanasa MC, Eisenfeld AJ, Stromatt SC, Gopal AK. Otlertuzumab (TRU-016), an anti-CD37 monospecific ADAPTIR(™) therapeutic protein, for relapsed or refractory NHL patients. Br J Haematol. 2015 Jan;168(1):38-45. doi: 10.1111/bjh.13099. Epub 2014 Aug 22.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Byrd JC, Pagel JM, Awan FT, Forero A, Flinn IW, Deauna-Limayo DP, Spurgeon SE, Andritsos LA, Gopal AK, Leonard JP, Eisenfeld AJ, Bannink JE, Stromatt SC, Furman RR. A phase 1 study evaluating the safety and tolerability of otlertuzumab, an anti-CD37 mono-specific ADAPTIR therapeutic protein in chronic lymphocytic leukemia. Blood. 2014 Feb 27;123(9):1302-8. doi: 10.1182/blood-2013-07-512137. Epub 2013 Dec 31.

Responsible Party:	Aptevo Therapeutics
ClinicalTrials.gov Identifier:	NCT00614042 History of Changes
Other Study ID Numbers:	16007
First Posted:	February 13, 2008
Last Update Posted:	June 28, 2017
Last Verified:	June 2017

Keywords provided by Aptevo Therapeutics:

CLL; NHL; TRU-016; chronic lymphocytic leukemia; non-Hodgkin's lymphoma

Additional relevant MeSH terms:

Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders	Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Immunoglobulin G; Immunologic Factors; Physiological Effects of Drugs