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Study of YM155 in Refractory Diffuse Large B-cell Lymphoma (DLBCL) Subjects | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study of YM155 in Refractory Diffuse Large B-cell Lymphoma (DLBCL) Subjects

A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

NCT00498914•Astellas Pharma Inc

Summary

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

Detailed Description

1 arm (Active), Phase 2 Study to evaluate response rate, efficacy, safety and tolerability of YM155

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+3 more criteria

Exclusion Criteria

•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
+10 more criteria

Locations (22)

Beverly Hills, California, United States

Palo Alto, California, United States

Aurora, Colorado, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Shreveport, Louisiana, United States

St Louis, Missouri, United States

Winston-Salem, North Carolina, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

June 1, 2007

Primary Completion Date

April 1, 2009

Completion Date

April 1, 2009

Last Updated

September 4, 2015

Enrollment

ACTUAL participants

Conditions

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

Interventions

YM155

DRUG

R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma

NCT00135499

Lymphoma, Large-Cell, Diffuse

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TERMINATEDPHASE2

PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma

NCT00511043

Lymphoma, Large-Cell, Diffuse

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COMPLETEDPHASE1/PHASE2

Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL

NCT00379574

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.