Study of YM155 in Refractory Diffuse Large B-cell Lymphoma (DLBCL) Subjects

August 20, 2015 updated by: Astellas Pharma Inc

A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

1 arm (Active), Phase 2 Study to evaluate response rate, efficacy, safety and tolerability of YM155

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
  • France
      • Bordeaux, France, 33076
      • Montpellier, France, 34295
      • Nantes, France, 44093
      • Nice, France, 06200
      • Poitiers, France, 86021
      • Rouen, France, 76038
      • Tours, France, 37044
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28041
  • United States
    • California
      • Beverly Hills, California, United States, 90211
      • Palo Alto, California, United States, 94305
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Miami, Florida, United States, 33136
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
    • Missouri
      • St Louis, Missouri, United States, 63110
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
    • Oregon
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
    • Texas
      • Houston, Texas, United States, 77303
      • San Antonio, Texas, United States, 78229

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:

  • Male or female subjects aged 18 years or older
  • Histologically confirmed primary DLBCL of any stage
  • Refractory to the last treatment regimen
  • Previously treated with the following treatment regimens:
  • Anthracycline-based combination chemotherapy with rituximab
  • Second-line combination chemotherapy
  • Autologous BMT if the subject was eligible and did not refuse the procedure
  • At least one measurable lesion defined as > 1.5 cm in the longest diameter
  • No known central nervous system involvement
  • ECOG performance status < 2
  • Life expectancy > 12 weeks
  • If female, non-pregnant and non-lactating
  • IRB-approved consent and HIPAA Authorization

Exclusion Criteria:

  • Transformed, composite or discordant lymphoma
  • Therapy for lymphoma within 21 days prior to the first dose of YM155
  • Within 4 weeks of the screening FDG-PET scan, receipt of the following:
  • Radiation therapy
  • Surgical procedures (except biopsies and central catheter / port placement)
  • Active infection (bloodstream or deep tissue)
  • Inadequate marrow, hepatic and/or renal function
  • Serum creatinine > 1.5 x ULN or calculated serum creatinine clearance < 60 mL/min
  • Absolute Neutrophil Count (ANC) < 750/mm3
  • Platelet < 50,000/mm3
  • Alanine Transaminase (ALT) and Aspartate Transaminase (AST) > 2.5 x ULN; > 5 x ULN if secondary to liver metastases
  • Treated with > 3 prior treatment regimens. The following should be considered:
  • Planned maintenance therapy should be considered as part of the previous treatment regimen
  • Any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) should be included with the autologous BMT or PBSCT as one treatment
  • Prior allogeneic BMT or PBSCT
  • Previously treated with YM155
  • Other investigational therapy or procedures within 28 days
  • Known HIV, hepatitis B surface antigen, or hepatitis C antibody
  • Other malignancy requiring treatment within 2 years
  • Significant and/or uncontrolled cardiac, renal, hepatic, or other systemic disorders or significant psychological conditions that in the Investigator's judgment would jeopardize subject enrollment or compliance

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: YM155
Continuous IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: 15 treatment cycles
15 treatment cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety, efficacy, pharmacokinetics, and tolerability
Time Frame: 15 treatment cycles
15 treatment cycles

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

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

June 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

July 10, 2007

First Submitted That Met QC Criteria

July 10, 2007

First Posted (Estimate)

July 11, 2007

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

August 20, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 155-CL-009
  • Eudra CT 2006-002584-70

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.

Subscribe