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

May 26, 2021 updated by: Aptevo Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • For additional information regarding sites for this trial call (919) 465-4648
  • Germany
      • Bremen, Germany
        • For additional information regarding sites for this trial call (919) 465-4648
      • Cologne, Germany
        • For additional information regarding sites for this trial call (919) 465-4648
      • Frankfurt, Germany
        • For additional information regarding sites for this trial call (919) 465-4648
      • Gottingen, Germany
        • For additional information regarding sites for this trial call (919) 465-4648
      • Kiel, Germany
        • For additional information regarding sites for this trial call (919) 465-4648
      • Mainz, Germany
        • For additional information regarding sites for this trial call (919) 465-4648
      • Mutlangen, Germany
        • For additional information regarding sites for this trial call (919) 465-4648
      • Regensburg, Germany
        • For additional information regarding sites for this trial call (919) 465-4648
  • Poland
      • Bialystok, Poland
        • For additional information regarding sites for this trial call (919) 465-4648
      • Gdansk, Poland
        • For additional information regarding sites for this trial call (919) 465-4648
      • Lodz, Poland
        • For additional information regarding sites for this trial call (919) 465-4648
      • Poznan, Poland
        • For additional information regarding sites for this trial call (919) 465-4648
      • Warsaw, Poland
        • For additional information regarding sites for this trial call (919) 465-4648
  • Spain
      • Madrid, Spain
        • For additional information regarding sites for this trial call (919) 465-4648
      • Navarre, Spain
        • For additional information regarding sites for this trial call (919) 465-4648
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • For additional information regarding sites for this trial call (919) 465-4648
    • Georgia
      • Augusta, Georgia, United States, 30912
        • For additional information regarding sites for this trial call (919) 465-4648
    • Illinois
      • Chicago, Illinois, United States, 60637
        • For additional information regarding sites for this trial call (919) 465-4648
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • For additional information regarding sites for this trial call (919) 465-4648
    • New York
      • Syracuse, New York, United States, 13210
        • For additional information regarding sites for this trial call (919) 465-4648
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • For additional information regarding sites for this trial call (919) 465-4648
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • For additional information regarding sites for this trial call (919) 465-4648
      • Columbus, Ohio, United States, 43210
        • For additional information regarding sites for this trial call (919) 465-4648
    • Washington
      • Seattle, Washington, United States, 98109
        • For additional information regarding sites for this trial call (919) 465-4648

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aptevo Therapeutics

Investigators

  • Study Director: Scott Stromatt, MD, Emergent Product Development Seattle LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 20, 2010

First Submitted That Met QC Criteria

August 24, 2010

First Posted (Estimate)

August 25, 2010

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

May 26, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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