A Study to Evaluate the Safety and Efficacy of Dasatinib (Sprycel) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Recruitment status was: Recruiting
This is a Phase II, single institution, single-arm, open-label study of oral dasatinib monotherapy administered to subjects with relapsed or refractory aggressive DLBCL.
This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.
Research Hypothesis: Dasatinib, when administered orally at a continuous dose of 100 mg once daily, will be safe and effective in treating subjects that have failed prior therapies to diffuse large B cell lymphoma (DLBCL) or have relapsed disease.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Single-Institution, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of a Single Agent Dasatinib (Sprycel) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma|
- To determine the efficacy of dasatinib monotherapy in relapsed or refractory aggressive Diffuse Large B-Cell Lymphoma (DLBCL). Efficacy will be assessed by measuring the response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To evaluate the safety of dasatinib monotherapy as treatment for subjects with relapsed or refractory aggressive DLBCL. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To determine potential correlatives of response. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Experimental: all patients||
100 mg daily dosing
Other Name: Sprycel
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918463
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10021|
|Principal Investigator:||Rebecca Elstrom, MD||Weill Medical College of Cornell University|