NCT01188681 - Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions

Chronic Lymphocytic Leukemia (CLL)

Interventions

DRUG

TRU-016 and bendamustine

TRU-016 at 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

DRUG

Bendamustine

Bendamustine at 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

DRUG

15 mg/kg TRU-016 and bendamustine

TRU-016 at 15 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

DRUG

20 mg/kg TRU-016 and bendamustine

TRU-016 at 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

Trial Locations (25)

13210

For additional information regarding sites for this trial call (919) 465-4648, Syracuse

27710

For additional information regarding sites for this trial call (919) 465-4648, Durham

30912

For additional information regarding sites for this trial call (919) 465-4648, Augusta

43210

For additional information regarding sites for this trial call (919) 465-4648, Columbus

44195

For additional information regarding sites for this trial call (919) 465-4648, Cleveland

60637

For additional information regarding sites for this trial call (919) 465-4648, Chicago

80218

For additional information regarding sites for this trial call (919) 465-4648, Denver

98109

For additional information regarding sites for this trial call (919) 465-4648, Seattle

07601

For additional information regarding sites for this trial call (919) 465-4648, Hackensack

Unknown

For additional information regarding sites for this trial call (919) 465-4648, Vienna

For additional information regarding sites for this trial call (919) 465-4648, Bremen

For additional information regarding sites for this trial call (919) 465-4648, Cologne

For additional information regarding sites for this trial call (919) 465-4648, Frankfurt

For additional information regarding sites for this trial call (919) 465-4648, Göttingen

For additional information regarding sites for this trial call (919) 465-4648, Kiel

For additional information regarding sites for this trial call (919) 465-4648, Mainz

For additional information regarding sites for this trial call (919) 465-4648, Mutlangen

For additional information regarding sites for this trial call (919) 465-4648, Regensburg

For additional information regarding sites for this trial call (919) 465-4648, Bialystok

For additional information regarding sites for this trial call (919) 465-4648, Gdansk

For additional information regarding sites for this trial call (919) 465-4648, Lodz

For additional information regarding sites for this trial call (919) 465-4648, Poznan

For additional information regarding sites for this trial call (919) 465-4648, Warsaw

For additional information regarding sites for this trial call (919) 465-4648, Madrid

For additional information regarding sites for this trial call (919) 465-4648, Navarre