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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT00498914
Collaborator
(none)
41
Enrollment
22
Locations
1
Arm
22
Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: YM155
Continuous IV infusion

Outcome Measures

Primary Outcome Measures

  1. Overall response rate [15 treatment cycles]

Secondary Outcome Measures

  1. Safety, efficacy, pharmacokinetics, and tolerability [15 treatment cycles]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • Life expectancy > 12 weeks

  • If female, non-pregnant and non-lactating

  • IRB-approved consent and HIPAA Authorization

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

  • 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

  • Previously treated with YM155

  • Other investigational therapy or procedures within 28 days

  • Known HIV, hepatitis B surface antigen, or hepatitis C antibody

  • Other malignancy requiring treatment within 2 years

  • Significant and/or uncontrolled cardiac, renal, hepatic, or other systemic disorders or significant psychological conditions that in the Investigator's judgment would jeopardize subject enrollment or compliance

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beverly Hills California United States 90211
2 Palo Alto California United States 94305
3 Aurora Colorado United States 80045
4 Miami Florida United States 33136
5 Atlanta Georgia United States 30322
6 Shreveport Louisiana United States 71130
7 St Louis Missouri United States 63110
8 Winston-Salem North Carolina United States 27157
9 Portland Oregon United States 97213
10 Philadelphia Pennsylvania United States 19111
11 Houston Texas United States 77303
12 San Antonio Texas United States 78229
13 Ottawa Ontario Canada K1H 8L6
14 Bordeaux France 33076
15 Montpellier France 34295
16 Nantes France 44093
17 Nice France 06200
18 Poitiers France 86021
19 Rouen France 76038
20 Tours France 37044
21 Barcelona Spain 08035
22 Madrid Spain 28041

Sponsors and Collaborators

  • Astellas Pharma Inc

Investigators

  • Study Director: Use Central Contact, Astellas Pharma Global Development

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00498914
Other Study ID Numbers:
  • 155-CL-009
  • Eudra CT 2006-002584-70
First Posted:
Jul 11, 2007
Last Update Posted:
Sep 4, 2015
Last Verified:
Aug 1, 2015
Keywords provided by Astellas Pharma Inc
Lymphoma, Large-Cell, Diffuse
Lymphoma, B-Cell
YM155
Treatment outcomes
Refractory
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse

Study Results

No Results Posted as of Sep 4, 2015