Clinical trial NCT01007292: A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: Non-Hodgkin's Lymphoma
relapsed
CD20-Positive
YM155
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-11-04
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)
timeFrame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Secondary outcomes:
measure: Confirmed Complete remission rate
timeFrame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
measure: Confirmed Partial remission rate
timeFrame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
measure: Time to response
timeFrame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
measure: Duration of response
timeFrame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
measure: Clinical benefit rate
timeFrame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
measure: Progression-free survival
timeFrame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
measure: Overall survival
timeFrame: 1 year after the last subject completes treatment
measure: Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
timeFrame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Site US2778 John B. Amos Cancer Center
state: Georgia
city: Maywood
country: United States
facility: Site US55 Loyola University Hospital - Maywood
state: Illinois
city: New York
country: United States
facility: Site US9 Mount Sinai School of Medicine
state: New York
city: Charlotte
country: United States
facility: Site US2802 Mecklenburg Medical Group
state: North Carolina
city: Canton
country: United States
facility: Site US2149 Gabrail Cancer Center Research
state: Ohio
city: San Antonio
country: United States
facility: Site US402 University of Texas Health Science Center - San Antonio
state: Texas
city: Bordeaux-cedex
country: France
facility: Site FR1926 Institut Bergonie
city: Nice
country: France
facility: Site FR2700 Centre Antoine Lacassagne
city: Paris
country: France
facility: Site FR476 Hopital Saint Louis
city: Rouen
country: France
facility: Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel
city: Tours
country: France
facility: Site FR1897 Hopital Bretonneau
city: Barcelona
country: Spain
facility: Site ES1349 Hospital del Mar
city: Madrid
country: Spain
facility: Site ES1339 Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Site ES2967 Hosptial Universitario Madrid Sanchinarro
city: Salamanca
country: Spain
facility: Site ES1346 Hospital Universitario de Salamanca
city: Cambridge
country: United Kingdom
facility: Site GB2702 Addenbrookes Hospital
city: London
country: United Kingdom
facility: Site GB1928 St. Georges Hospital
city: Manchester
country: United Kingdom
facility: Site GB2624 The Christie NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Site GB1903 Oxford Radcliffe Hospital
Study officials:
affiliation: Astellas Pharma Global Development
name: Senior Medical Director
role: STUDY_DIRECTOR
References: