Clinical Trials

Sponsor(s): Trubion Pharmaceuticals

Condition(s):

Chronic Lymphocytic Leukemia (CLL)
Leukemia
Cancer
Lymphocytic Leukemia, Chronic
Neoplasms

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

Eligibility:

Minimum Age:

18 Years

Accepts Healthy Volunteers:

No

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
- SGOT, SGPT
- 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
- Platelets
- Previous or concurrent additional malignancy

- Significant concurrent medical diseases or conditions

- Hepatitis B surface antigen positive

- Pregnant or breastfeeding

Other Location(s): Birmingham, Alabama United States,Las Vegas, Nevada United States,New York, New York United States,Columbus, Ohio United States,Nashville, Tennessee United States

Terms: This is an abstract courtesy of ClinicalTrials.gov, a service of the US National Institute of Health Developed by the National Library of Medicine. ClinicalTrials.gov provides regularly updates information about federally and privately supported clinical research in human volunteers.