A Phase 1/2 Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia - Full Text View

Sponsor:	Trubion Pharmaceuticals
Information provided by:	Trubion Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00614042

Purpose

The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients with previously treated chronic lymphocytic leukemia.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia (CLL)	Drug: TRU-016 (anti-CD37 protein therapeutic)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1/2 Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Further study details as provided by Trubion Pharmaceuticals:

Primary Outcome Measures:

Safety and tolerability of TRU-016 administered IV in patients with CLL [ 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 ]

Estimated Enrollment:	64
Study Start Date:	January 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dose escalation	Drug: TRU-016 (anti-CD37 protein therapeutic) TRU-016 (dose escalation study) administered via IV infusion over 4 weeks

Detailed Description:

This Phase 1/2 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 2 expansion cohort may be enrolled to confirm safety and to estimate the clinical benefit of TRU-016.

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
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) 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 positive
Pregnant or breastfeeding

Contacts and Locations

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

Contacts

Contact: Janine Koucheki

919-319-9374

jkoucheki@procro.com

Locations

United States, Alabama
For additional information regarding sites for this trial call 919-319-9374	Recruiting
Birmingham, Alabama, United States, 35294
United States, Nevada
For additional information regarding sites for this trial call 919-319-9374	Recruiting
Las Vegas, Nevada, United States, 89135
United States, New York
For additional information regarding sites for this trial call 919-319-9374	Recruiting
New York, New York, United States, 10021
United States, Ohio
For additional information regarding sites for this trial call 919-319-9374	Recruiting
Columbus, Ohio, United States, 43210
United States, Tennessee
For additional information regarding sites for this trial call 919-319-9374	Recruiting
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Trubion Pharmaceuticals

Investigators

Study Director:

Scott Stromatt, MD

Trubion Pharmaceuticals

More Information

No publications provided

Responsible Party:	Trubion Pharmaceuticals ( Scott Stromatt, M.D. )
Study ID Numbers:	16007
Study First Received:	January 25, 2008
Last Updated:	July 28, 2009
ClinicalTrials.gov Identifier:	NCT00614042 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Trubion Pharmaceuticals:

CLL, TRU-016, chronic lymphocytic leukemia

Additional relevant MeSH terms:

Lymphatic Diseases
Leukemia
Neoplasms
Leukemia, Lymphoid
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoproliferative Disorders
Leukemia, B-Cell

ClinicalTrials.gov processed this record on February 08, 2010