Overview

This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatments ym155, rituximab
Phase phase 2
Target CD20
Sponsor Astellas Pharma Inc
Start date November 2009
End date March 2013
Trial size 43 participants
Trial identifier NCT01007292, 155-CL-031

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ym155
intravenous infusion
rituximab Rituxan
intravenous infusion

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Confirmed Complete remission rate
time frame: 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
Time to response
time frame: 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
Clinical benefit rate
time frame: 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
Overall survival
time frame: 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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.