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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia (CLL)

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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