Status:
COMPLETED
Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia
Lead Sponsor:
Aptevo Therapeutics
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of the first part of the study is to determine a safe dose of TRU-016 that can be used in combination with bendamustine in patients with relapsed CLL. The objectives of the second part o...
Detailed Description
This study consisted of two parts. The initial dose escalation stage was a Phase 1b study evaluating the safety and tolerability of two doses of TRU-016 administered in combination with bendamustine t...
Eligibility Criteria
Inclusion
- Diagnosis of relapsed CLL with 1 to 3 prior treatments
- Demonstrated active disease requiring treatment
- No prior bendamustine treatment
- Not refractory to fludarabine or other purines, either as a single agent or in combination
- Age \>/=18 years; male or female
- Eastern Cooperative Oncology Group (ECOG) performance status of \</= 2
- Creatinine clearance \> 40 mL/min
- Absolute neutrophil count (ANC) \>/= 1,200/mm3
- Platelets \>/= 75,000/mm3
- Lymphocytes \>/= 5,000/mm3 in Phase 1b
Exclusion
- Treatment with rituximab or other B-cell depleting agent within 30 days or alemtuzumab within 12 weeks
- Previous anticancer therapy within 30 days
- Refractory to prior fludarabine or other purine analog therapy either as a single agent or in combination
- Receipt of prior bendamustine or TRU-016
- Receipt of an investigational therapy or major surgery within 30 days
- Previous or concurrent additional malignancy (some exceptions apply)
- Any significant concurrent medical diseases or conditions
- Positive serology for HIV or hepatitis C, hepatitis B surface antigen positive or hepatitis B core antibody positive.
- Pregnant or breast feeding
- Drug or alcohol abuse
- Allergic to mannitol
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01188681
Start Date
September 1 2010
End Date
December 1 2014
Last Update
June 10 2021
Active Locations (25)
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1
For additional information regarding sites for this trial call (919) 465-4648
Denver, Colorado, United States, 80218
2
For additional information regarding sites for this trial call (919) 465-4648
Augusta, Georgia, United States, 30912
3
For additional information regarding sites for this trial call (919) 465-4648
Chicago, Illinois, United States, 60637
4
For additional information regarding sites for this trial call (919) 465-4648
Hackensack, New Jersey, United States, 07601