An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)
A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
3 other identifiers
interventional
18
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2005
Shorter than P25 for phase_2
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
First Submitted
Initial submission to the registry
December 1, 2004
CompletedFirst Posted
Study publicly available on registry
December 2, 2004
CompletedStudy Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2006
CompletedApril 7, 2017
April 1, 2017
1.2 years
December 1, 2004
April 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate based on FDG-PET and CT scan findings.
Secondary Outcomes (1)
Response duration, Progression-free survival, Time to progression, Time to response, 3-Month and 6-month progression free survival.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 18296419BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
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
December 1, 2004
First Posted
December 2, 2004
Study Start
May 1, 2005
Primary Completion
July 31, 2006
Study Completion
July 31, 2006
Last Updated
April 7, 2017
Record last verified: 2017-04