Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
Completed · Phase 1
Conditions studied: Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL)
In brief
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.
Key facts
- Study ID
- NCT00614042
- Run by
- Aptevo Therapeutics
- People needed
- 96
- Starts
- 2008-01-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2017-06-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- For additional information regarding sites for this trial call 919-319-9374 — Birmingham, Alabama, United States
- For additional information regarding sites for this trial call 919-319-9374 — Augusta, Georgia, United States
- For additional information regarding sites for this trial call 919-319-9374 — Boston, Massachusetts, United States
- For additional information regarding sites for this trial call 919-319-9374 — Las Vegas, Nevada, United States
- For additional information regarding sites for this trial call 919-319-9374 — Durham, North Carolina, United States
- For additional information regarding sites for this trial call 919-319-9374 — Portland, Oregon, United States
- For additional information regarding sites for this trial call 919-319-9374 — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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