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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:
NCT01188681
First received: August 20, 2010
Last updated: May 24, 2013
Last verified: May 2013

August 20, 2010
May 24, 2013
September 2010
April 2015   (final data collection date for primary outcome measure)
Phase 1b: occurence of dose limiting toxicities in each dose cohort of Phase 1b [ Time Frame: following treatment of last patient enrolled with 2 cycles. ] [ Designated as safety issue: Yes ]
  • Phase 1b: occurence of dose limiting toxicities in each dose cohort. [ Time Frame: Phase 1b: following treatment of last patient enrolled with 2 cycles. ] [ Designated as safety issue: No ]
  • Phase 2: investigator-assessed overall response rate (ORR) by 2008 IWCLL Criteria. [ Time Frame: Phase 2: monthly until end of treatment (EOT), 30 and 60 days after EOT and every 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01188681 on ClinicalTrials.gov Archive Site
Compare PK and PD of different doses of TRU-016 with bendamustine [ Time Frame: Throughout treatment and follow-up ] [ Designated as safety issue: No ]
  • Complete response (CR) and ORR [ Time Frame: Monthly until EOT, 30 and 60 days after EOT and every 3 months thereafter ] [ Designated as safety issue: No ]
    1996 NCI Working Group Criteria
  • CR [ Time Frame: Monthly until EOT, 30 and 60 days after EOT and every 3 months thereafter ] [ Designated as safety issue: No ]
    2008 IWCLL Criteria
  • Progression-free survival (PFS) [ Time Frame: Monthly until EOT, 30 and 60 days after EOT and every 3 months thereafter ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Monthly until EOT, 30 and 60 days after EOT and every 3 months thereafter ] [ Designated as safety issue: No ]
  • Duration of overall response (DOR) [ Time Frame: Monthly until EOT, 30 and 60 days after EOT and every 3 months thereafter ] [ Designated as safety issue: No ]
  • Disease-related symptoms [ Time Frame: Monthly until EOT, 30 and 60 days after EOT and every 3 months thereafter ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: Before each TRU-016 or bendamustine infusion, at all post-treatment visits ] [ Designated as safety issue: No ]
  • Changes in laboratory parameters, vital signs and physical examinations [ Time Frame: Various throughout the study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia
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

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 of the study are to compare the safety and efficacy of TRU-016 in combination with bendamustine to bendamustine alone in patients with relapsed CLL.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia (CLL)
  • Other: TRU-016 and bendamustine
    15 mg/kg and 20 mg/kg TRU-016 by IV infusion weekly for the first two 28-day cycles and then every 14 days for the next four 28-day cycles. Bendamustine (70 mg/m2) by IV infusion on Days 1 and 2 of each 28-day cycle.
    Other Name: Treanda
  • Other: TRU-016 and bendamustine
    TRU-016 (n = 33 patients), at selected dose from Phase 1b, 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
    Other Name: Treanda
  • Drug: Bendamustine
    70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
    Other Name: Treanda
  • Experimental: Phase 1b: TRU-016 and bendamustine
    2 cohorts of 6 patients each to receive TRU-016 at 15 mg/kg or 20 mg/kg in combination with bendamustine (70 mg/m2)
    Intervention: Other: TRU-016 and bendamustine
  • Experimental: Phase 2: TRU-016 and bendamustine
    TRU-016 (n = 33 patients), at selected dose from Phase 1b and bendamustine (70 mg/m2)
    Intervention: Other: TRU-016 and bendamustine
  • Active Comparator: Phase 2: Bendamustine
    Bendamustine alone (n = 33 patients) (70 mg/m2)
    Intervention: Drug: Bendamustine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
78
December 2015
April 2015   (final data collection date for primary outcome measure)

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 </= 2
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain,   Austria,   Germany,   Poland
 
NCT01188681
16201
Yes
Emergent Product Development Seattle LLC
Emergent Product Development Seattle LLC
Not Provided
Study Director: Scott Stromatt, MD Emergent Product Development Seattle LLC
Emergent Product Development Seattle LLC
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP