Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active 18 and over Pharmaceutical / Industry 16007 NCT00614042

Trial Description

Summary

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

Further Study Information

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 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 >/= 1000/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 </= 1000/uL

• Platelets </= 30,000/mm3

• Previous or concurrent additional malignancy

• Significant concurrent medical diseases or conditions

• Hepatitis B surface antigen positive

• Pregnant or breastfeeding

Trial Contact Information

Trial Lead Organizations/Sponsors

Trubion Pharmaceuticals, Incorporated

Mack Mabry, M.D.

Study Director

Janine Koucheki		Ph: 919-319-9374
		Email: jkoucheki@procro.com

U.S.A.
New York
	New York
	For additional information regarding sites for this trial call 919-319-9374
Ohio
	Columbus
	For additional information regarding sites for this trial call 919-319-9374
Tennessee
	Nashville
	For additional information regarding sites for this trial call 919-319-9374

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00614042
Information obtained from ClinicalTrials.gov on July 16, 2008