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
  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)
Other: TRU-016 and bendamustine
Drug: Bendamustine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:
  • 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 ]

Secondary Outcome Measures:
  • Compare PK and PD of different doses of TRU-016 with bendamustine [ Time Frame: Throughout treatment and follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: September 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
Experimental: Phase 2: TRU-016 and bendamustine
TRU-016 (n = 33 patients), at selected dose from Phase 1b and bendamustine (70 mg/m2)
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
Active Comparator: Phase 2: Bendamustine
Bendamustine alone (n = 33 patients) (70 mg/m2)
Drug: Bendamustine
70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
Other Name: Treanda

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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
  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

No publications provided

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
Last Updated: May 24, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014