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

Purpose

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


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia Lymphoma

Genetic and Rare Diseases Information Center resources: Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Lymphosarcoma

U.S. FDA Resources

Further study details as provided by Emergent Product Development Seattle LLC:

Primary Outcome Measures:

Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Preliminary indication of response as defined by NCI 1996 criteria [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]


Enrollment:	96
Study Start Date:	January 2008
Study Completion Date:	March 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614042

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

Emergent Product Development Seattle LLC

Investigators


Study Director:	Scott Stromatt, MD	Emergent Product Development Seattle LLC

More Information

Publications:

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.

Additional 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:	Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:	NCT00614042 History of Changes
Other Study ID Numbers:	16007
Study First Received:	January 25, 2008
Last Updated:	January 26, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emergent Product Development Seattle LLC:


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

Additional relevant MeSH terms:


Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Immune System Diseases	Immunoproliferative Disorders Leukemia, B-Cell Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 25, 2015