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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007292
• Other study ID #: 155-CL-031
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2009
• Last updated: September 29, 2015
• Start date: November 2009
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• YM155
intravenous infusion

Biological:
• Rituximab
intravenous infusion

Locations

Country	Name	City	State
France	Site FR1926 Institut Bergonie	Bordeaux-cedex
France	Site FR2700 Centre Antoine Lacassagne	Nice
France	Site FR476 Hopital Saint Louis	Paris
France	Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel	Rouen
France	Site FR1897 Hopital Bretonneau	Tours
Spain	Site ES1349 Hospital del Mar	Barcelona
Spain	Site ES1339 Hospital Universitario Ramon y Cajal	Madrid
Spain	Site ES2967 Hosptial Universitario Madrid Sanchinarro	Madrid
Spain	Site ES1346 Hospital Universitario de Salamanca	Salamanca
United Kingdom	Site GB2702 Addenbrookes Hospital	Cambridge
United Kingdom	Site GB1928 St. Georges Hospital	London
United Kingdom	Site GB2624 The Christie NHS Foundation Trust	Manchester
United Kingdom	Site GB1903 Oxford Radcliffe Hospital	Oxford
United States	Site US2149 Gabrail Cancer Center Research	Canton	Ohio
United States	Site US2802 Mecklenburg Medical Group	Charlotte	North Carolina
United States	Site US2778 John B. Amos Cancer Center	Columbus	Georgia
United States	Site US55 Loyola University Hospital - Maywood	Maywood	Illinois
United States	Site US9 Mount Sinai School of Medicine	New York	New York
United States	Site US402 University of Texas Health Science Center - San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)		After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment	No
Secondary	Confirmed Complete remission rate		After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment	No
Secondary	Confirmed Partial remission rate		After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment	No
Secondary	Time to response		After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment	No
Secondary	Duration of response		After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment	No
Secondary	Clinical benefit rate		After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment	No
Secondary	Progression-free survival		After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment	No
Secondary	Overall survival		1 year after the last subject completes treatment	No
Secondary	Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)		After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment	No