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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:
NCT01188681
First received: August 20, 2010
Last updated: November 8, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Drug: TRU-016 and bendamustine
Drug: Bendamustine
Drug: 15 mg/kg TRU-016 and bendamustine
Drug: 20 mg/kg TRU-016 and bendamustine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Emergent Product Development Seattle LLC:

Primary Outcome Measures:
  • Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria [ Time Frame: 1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years ]
    Patients had full clinical response assessment monthly during treatment, at the end of treatment (EOT) visit, 30 and 60 days after the EOT visit, and subsequently every 3 months until the earliest of progression of CLL, death, initiation of new therapy, withdrawal from the study, or completion of 18 months of follow-up evaluations. Clinical response assessment included physical examination with measurement of spleen, liver, and lymph nodes, disease-related symptoms, and laboratory measurements, specifically complete blood count (CBC) with differential.


Secondary Outcome Measures:
  • Response Per NCI Criteria [ Time Frame: 1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years ]
    Overall response rate per National Cancer Institute (NCI) Working group criteria.


Enrollment: 79
Study Start Date: September 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1: 15 mg/kg TRU-016 + Bendamustine
TRU-016 (15 mg/kg) and bendamustine (70 mg/m2), n = 6 patients
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
Experimental: Phase 1: 20 mg/kg TRU-016 + Bendamustine
TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 6 patients
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
Experimental: Phase 2: TRU-016 and bendamustine
TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 32 patients
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
Active Comparator: Phase 2: Bendamustine
Bendamustine (70 mg/m2), n = 33 patients
Drug: Bendamustine
Bendamustine at 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

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 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 20 mg/kg TRU-016 combined with bendamustine was compared to bendamustine alone. The pharmacokinetics and pharmacodynamics of TRU-016 and the development of antibodies to TRU-016 were evaluated in both phases of the study.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188681

Locations
United States, Colorado
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Denver, Colorado, United States, 80218
United States, Georgia
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Augusta, Georgia, United States, 30912
United States, Illinois
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Chicago, Illinois, United States, 60637
United States, New Jersey
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Hackensack, New Jersey, United States, 07601
United States, New York
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Syracuse, New York, United States, 13210
United States, North Carolina
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Durham, North Carolina, United States, 27710
United States, Ohio
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Cleveland, Ohio, United States, 44195
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Columbus, Ohio, United States, 43210
United States, Washington
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Seattle, Washington, United States, 98109
Austria
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Vienna, Austria
Germany
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Bremen, Germany
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Cologne, Germany
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Frankfurt, Germany
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Gottingen, Germany
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Kiel, Germany
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Mainz, Germany
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Mutlangen, Germany
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Regensburg, Germany
Poland
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Bialystok, Poland
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Gdansk, Poland
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Lodz, Poland
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Poznan, Poland
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Warsaw, Poland
Spain
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Madrid, Spain
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Navarra, Spain
Sponsors and Collaborators
Emergent Product Development Seattle LLC
Investigators
Study Director: Scott Stromatt, MD Emergent Product Development Seattle LLC
  More Information

Responsible Party: Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier: NCT01188681     History of Changes
Other Study ID Numbers: 16201
Study First Received: August 20, 2010
Results First Received: May 17, 2016
Last Updated: November 8, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Emergent Product Development Seattle LLC:
CLL
TRU-016
chronic lymphocytic leukemia
relapsed CLL
bendamustine

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Bendamustine Hydrochloride
Immunoglobulin G
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 28, 2017