Back to resultsAn Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)
Primary Purpose
B-cell Lymphoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Lymphoma focused on measuring Relapsed Diffuse Large B-cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Patient must be 18 years or older with relapsed Diffuse Large B-cell Lymphoma (DLBCL). Stable disease or better for at least 3 months on most recent treatment Have not received any chemotherapy, radiation therapy, major surgery, or any other investigational therapy for at least 4 weeks prior to entry in this study Adequate blood testing, liver, and kidney function as required by the study. Eligible subjects will allow tissue samples to be examined and stored. Exclusion Criteria: Patient has been treated with other investigational agents with a similar anti-tumor mechanism. Patient should not have failed more than 3 prior treatment regimens.
Sites / Locations
Outcomes
Primary Outcome Measures
Objective response rate based on FDG-PET and CT scan findings.
Secondary Outcome Measures
Response duration, Progression-free survival, Time to progression, Time to response, 3-Month and 6-month progression free survival.
Full Information
NCT ID
NCT00097929
First Posted
December 1, 2004
Last Updated
April 5, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00097929
Brief Title
An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)
Official Title
A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2005 (Actual)
Primary Completion Date
July 31, 2006 (Actual)
Study Completion Date
July 31, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Lymphoma
Keywords
Relapsed Diffuse Large B-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months
Primary Outcome Measure Information:
Title
Objective response rate based on FDG-PET and CT scan findings.
Secondary Outcome Measure Information:
Title
Response duration, Progression-free survival, Time to progression, Time to response, 3-Month and 6-month progression free survival.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must be 18 years or older with relapsed Diffuse Large B-cell Lymphoma (DLBCL).
Stable disease or better for at least 3 months on most recent treatment
Have not received any chemotherapy, radiation therapy, major surgery, or any other investigational therapy for at least 4 weeks prior to entry in this study
Adequate blood testing, liver, and kidney function as required by the study.
Eligible subjects will allow tissue samples to be examined and stored.
Exclusion Criteria:
Patient has been treated with other investigational agents with a similar anti-tumor mechanism.
Patient should not have failed more than 3 prior treatment regimens.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18296419
Citation
Crump M, Coiffier B, Jacobsen ED, Sun L, Ricker JL, Xie H, Frankel SR, Randolph SS, Cheson BD. Phase II trial of oral vorinostat (suberoylanilide hydroxamic acid) in relapsed diffuse large-B-cell lymphoma. Ann Oncol. 2008 May;19(5):964-9. doi: 10.1093/annonc/mdn031. Epub 2008 Feb 21.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis Links
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)
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