A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment

September 29, 2015 updated by: Astellas Pharma Inc

A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin's Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant

The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an outpatient study. All subjects enrolled in this study will receive YM155 and rituximab given during 14 day cycles. Each subject will be assessed at the end of each cycle to determine if he or she may continue to the next cycle. Each subject will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.

If a subject discontinues treatment without progressive disease (PD) that subject will complete follow-up visits every 12 weeks for 1 year or until initiating another systemic anti-lymphoma treatment, exhibiting PD, or death.

Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 1 year.

Study Type

Interventional

Enrollment (Actual)

43

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

  • France
      • Bordeaux-cedex, France, 33076
        • Site FR1926 Institut Bergonie
      • Nice, France, 06189
        • Site FR2700 Centre Antoine Lacassagne
      • Paris, France, 75475
        • Site FR476 Hopital Saint Louis
      • Rouen, France, 76038
        • Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel
      • Tours, France, 37044
        • Site FR1897 Hopital Bretonneau
  • Spain
      • Barcelona, Spain, 08003
        • Site ES1349 Hospital del Mar
      • Madrid, Spain, 28034
        • Site ES1339 Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28050
        • Site ES2967 Hosptial Universitario Madrid Sanchinarro
      • Salamanca, Spain, 37007
        • Site ES1346 Hospital Universitario de Salamanca
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Site GB2702 Addenbrookes Hospital
      • London, United Kingdom, SW17 0QT
        • Site GB1928 St. Georges Hospital
      • Manchester, United Kingdom, M20 4BX
        • Site GB2624 The Christie NHS Foundation Trust
      • Oxford, United Kingdom, OX3 7LJ
        • Site GB1903 Oxford Radcliffe Hospital
  • United States
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Site US2778 John B. Amos Cancer Center
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Site US55 Loyola University Hospital - Maywood
    • New York
      • New York, New York, United States, 10029
        • Site US9 Mount Sinai School of Medicine
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Site US2802 Mecklenburg Medical Group
    • Ohio
      • Canton, Ohio, United States, 44718
        • Site US2149 Gabrail Cancer Center Research
    • Texas
      • San Antonio, Texas, United States, 78229
        • Site US402 University of Texas Health Science Center - San Antonio

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:

  • Any stage, histologically confirmed CD20-positive primary or transformed diffuse large B cell lymphoma (DLBCL)or grade 3 follicular lymphoma (FL)
  • Ineligible for or have previously received an autologous stem cell transplant (ASCT)
  • Relapsed following receipt of the last dose of systemic chemotherapy or ASCT
  • At least one prior chemotherapy regimen. Prior chemotherapy regimen must have contained anthracycline (unless contraindicated)
  • If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
  • Eastern Cooperative Oncology Group (ECOG) performance status </= 1

Exclusion Criteria:

  • Use of any standard/experimental anti-lymphoma drug therapy within 21 days of the Baseline Visit
  • Use of systemic steroids within 5 days of the Baseline Visit (except for the purposes of pre-medication prior to study regimen treatment)
  • Prior allogeneic stem cell transplant (SCT)
  • The subject has been previously treated with YM155
  • The subject has known human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibody
  • The subject has received other investigational therapy or procedures within 21 days prior to the first study drug administration

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YM155 plus rituximab
Drug: YM155
intravenous infusion
Biological: Rituximab
intravenous infusion
Other Names:
  • Rituxan
  • Mabthera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)
Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Confirmed Complete remission rate
Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Confirmed Partial remission rate
Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Time to response
Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Duration of response
Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Clinical benefit rate
Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Progression-free survival
Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Overall survival
Time Frame: 1 year after the last subject completes treatment
1 year after the last subject completes treatment
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment

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

November 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (Estimate)

November 4, 2009

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 155-CL-031

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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