NCT00498914

Brief Summary

A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2007

Geographic Reach
4 countries

22 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 4, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

July 10, 2007

Last Update Submit

August 20, 2015

Conditions

Lymphoma, Large-Cell, DiffuseLymphoma, B-Cell Refractory

Keywords

Lymphoma, Large-Cell, DiffuseLymphoma, B-CellYM155Treatment outcomesRefractory

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    15 treatment cycles

Secondary Outcomes (1)

  • Safety, efficacy, pharmacokinetics, and tolerability

    15 treatment cycles

Study Arms (1)

1

EXPERIMENTAL
Drug: YM155

Interventions

YM155DRUG

Continuous IV infusion

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects aged 18 years or older
  • Histologically confirmed primary DLBCL of any stage
  • Refractory to the last treatment regimen
  • Previously treated with the following treatment regimens:
  • Anthracycline-based combination chemotherapy with rituximab
  • Second-line combination chemotherapy
  • Autologous BMT if the subject was eligible and did not refuse the procedure
  • At least one measurable lesion defined as \> 1.5 cm in the longest diameter
  • No known central nervous system involvement
  • ECOG performance status \< 2
  • Life expectancy \> 12 weeks
  • If female, non-pregnant and non-lactating
  • IRB-approved consent and HIPAA Authorization

You may not qualify if:

  • Transformed, composite or discordant lymphoma
  • Therapy for lymphoma within 21 days prior to the first dose of YM155
  • Within 4 weeks of the screening FDG-PET scan, receipt of the following:
  • Radiation therapy
  • Surgical procedures (except biopsies and central catheter / port placement)
  • Active infection (bloodstream or deep tissue)
  • Inadequate marrow, hepatic and/or renal function
  • Serum creatinine \> 1.5 x ULN or calculated serum creatinine clearance \< 60 mL/min
  • Absolute Neutrophil Count (ANC) \< 750/mm3
  • Platelet \< 50,000/mm3
  • Alanine Transaminase (ALT) and Aspartate Transaminase (AST) \> 2.5 x ULN; \> 5 x ULN if secondary to liver metastases
  • Treated with \> 3 prior treatment regimens. The following should be considered:
  • Planned maintenance therapy should be considered as part of the previous treatment regimen
  • Any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) should be included with the autologous BMT or PBSCT as one treatment
  • Prior allogeneic BMT or PBSCT
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Beverly Hills, California, 90211, United States

Location

Unknown Facility

Palo Alto, California, 94305, United States

Location

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Shreveport, Louisiana, 71130, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157, United States

Location

Unknown Facility

Portland, Oregon, 97213, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19111, United States

Location

Unknown Facility

Houston, Texas, 77303, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Ottawa, Ontario, K1H 8L6, Canada

Location

Unknown Facility

Bordeaux, 33076, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Nantes, 44093, France

Location

Unknown Facility

Nice, 06200, France

Location

Unknown Facility

Poitiers, 86021, France

Location

Unknown Facility

Rouen, 76038, France

Location

Unknown Facility

Tours, 37044, France

Location

Unknown Facility

Barcelona, 08035, Spain

Location

Unknown Facility

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphomaLymphoma, B-Cell

Interventions

sepantronium

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Use Central Contact

    Astellas Pharma Global Development

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 11, 2007

Study Start

June 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

September 4, 2015

Record last verified: 2015-08

Locations

CA(1)FR(7)US(12)ES(2)