Status:
COMPLETED
Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
Lead Sponsor:
Aptevo Therapeutics
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Non-Hodgkin's Lymphoma (NHL)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 pati...
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00614042
Start Date
January 1 2008
End Date
March 1 2012
Last Update
June 28 2017
Active Locations (7)
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1
For additional information regarding sites for this trial call 919-319-9374
Birmingham, Alabama, United States, 35294
2
For additional information regarding sites for this trial call 919-319-9374
Augusta, Georgia, United States, 30912
3
For additional information regarding sites for this trial call 919-319-9374
Boston, Massachusetts, United States, 02111
4
For additional information regarding sites for this trial call 919-319-9374
Las Vegas, Nevada, United States, 89135