A Phase 1b/2 Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination With Bendamustine vs. Bendamustine Alone in Patients With Relapsed Chronic Lymphocytic Leukemia
18 Years
N/A
Both
Chronic Lymphocytic Leukemia (CLL)
Trial Information
A Phase 1b/2 Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination With Bendamustine vs. Bendamustine Alone in Patients With Relapsed Chronic Lymphocytic Leukemia
This Phase 1/1b open-label study consists of two parts. The initial dose escalation stage is
a Phase 1b study evaluating the safety and tolerability of two doses of TRU-016 administered
in combination with bendamustine to patients with relapsed chronic lymphocytic leukemia
(CLL). In the randomized Phase 2 stage of the study, the efficacy and safety of the selected
dose of TRU-016 from the first stage of the study combined with bendamustine will be
compared to bendamustine alone. The pharmacokinetics and pharmacodynamics of TRU-016 and
the development of antibodies to TRU-016 will be evaluated in both phases of the study.
Inclusion Criteria:
- 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
- ECOG performance status of
- Creatinine clearance > 40 mL/min
- ANC >/= 1,200/mm3
- Platelets >/= 75,000/mm3
- Lymphocytes >/= 5,000/mm3 in Phase 1b
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase 1b: occurence of dose limiting toxicities in each dose cohort of Phase 1b
Outcome Time Frame:
following treatment of last patient enrolled with 2 cycles.
Safety Issue:
Yes
Principal Investigator
Scott Stromatt, MD
Investigator Role:
Study Director
Investigator Affiliation:
Emergent Product Development Seattle LLC
Authority:
United States: Food and Drug Administration
Study ID:
16201
NCT ID:
NCT01188681
Start Date:
September 2010
Completion Date:
December 2015
Related Keywords:
- Chronic Lymphocytic Leukemia (CLL)
- CLL
- TRU-016
- chronic lymphocytic leukemia
- relapsed CLL
- bendamustine
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| For additional information regarding sites for this trial call (919) 465-4648 | Denver, Colorado 80218 |
| For additional information regarding sites for this trial call (919) 465-4648 | Augusta, Georgia 30912 |
| For additional information regarding sites for this trial call (919) 465-4648 | Chicago, Illinois 60637 |
| For additional information regarding sites for this trial call (919) 465-4648 | Hackensack, New Jersey 07601 |
| For additional information regarding sites for this trial call (919) 465-4648 | Syracuse, New York 13210 |
| For additional information regarding sites for this trial call (919) 465-4648 | Chapel Hill, North Carolina 27599 |
| For additional information regarding sites for this trial call (919) 465-4648 | Cleveland, Ohio 44195 |
| For additional information regarding sites for this trial call (919) 465-4648 | Seattle, Washington 98109 |
