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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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.


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
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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)

Outcome Time Frame:

After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment

Safety Issue:

No

Principal Investigator

Senior Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

155-CL-031

NCT ID:

NCT01007292

Start Date:

November 2009

Completion Date:

December 2013

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • relapsed
  • CD20-Positive
  • YM155
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Yale Cancer CenterNew Haven, Connecticut  06520-8028
John B. Amos Cancer CenterColumbus, Georgia  31904
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Gabrail Cancer CenterCanton, Ohio  44718
Mount Sinai HospitalNew York, New York  10029
Loyola University HospitalMaywood, Illinois  60153
Blumenthal Cancer Center Oncology ResearchCharlotte, North Carolina  28204
CTRC at The University of Texas Health Science CenterSan Antonio, Texas  78229