The purpose of this research study is to find the maximum tolerated dose of a drug called romidepsin when given with a treatment regimen called GemOxD. GemOxD is a routine treatment for certain types of lymphoma, and involves the administration of three drugs: gemcitabine, oxaliplatin, and dexamethasone. In addition to finding the maximum tolerated dose of romidepsin, the investigators want to look at the side effects of these drugs when given together, as well as how the lymphoma responds to this treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
University of Chicago
Chicago, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
Maximum tolerated dose (recommended Phase II dose)
Three participants will be treated at each dose level. If 0/3 patients experience dose limiting toxicity (DLT), 3 patients will be treated at the next dose level. If a DLT attributable to the treatment is experienced in 1 of 3 patients, three more patients (for a total of six participants) will be treated at that dose level. If no additional DLTs are observed at the expanded dose level (i.e. 1 of 6 with DLT), the dose will be escalated. Escalation will terminate as soon as two or more participants experience any DLT attributable to study combination, at a given dose level. If 2 or more DLTs occur at the starting dose level, a decreased dose level will be explored at dose level -1. There will be no more than 2 patients dosed for the first time within the same week, and patients in the next higher cohorts will not be enrolled until the last patient of the lower cohort has completed the DLT monitoring period, defined as 21 days after first dose of Cycle 1 therapy.
Time frame: 37 months (completion of first cycle of all participants in study)
Complete response rate
For study participants with relapsed/refractory peripheral T-cell lymphoma (PTCL), diffuse large b-cell lymphoma (DLBCL), and Hodgkin's lymphoma response will be assessed in accordance with the updated International Working Group (IWG) recommendations. For study participants with cutaneous t-cell lymphoma (CTCL), the Global Response Score established by the ISCL/USCLC/EORTC consensus panel will be used to assess response to treatment.
Time frame: Up to 1 year from time of maximal response
Partial response rate
For study participants with relapsed/refractory peripheral T-cell lymphoma (PTCL), diffuse large b-cell lymphoma (DLBCL), and Hodgkin's lymphoma response will be assessed in accordance with the updated International Working Group (IWG) recommendations. For study participants with cutaneous t-cell lymphoma (CTCL), the Global Response Score established by the ISCL/USCLC/EORTC consensus panel will be used to assess response to treatment.
Time frame: Up to 1 year from time of maximal response
Overall response rate
For study participants with relapsed/refractory peripheral T-cell lymphoma (PTCL), diffuse large b-cell lymphoma (DLBCL), and Hodgkin's lymphoma response will be assessed in accordance with the updated International Working Group (IWG) recommendations. For study participants with cutaneous t-cell lymphoma (CTCL), the Global Response Score established by the ISCL/USCLC/EORTC consensus panel will be used to assess response to treatment. Overall response rate = complete response + partial response
Time frame: Up to 1 year from time of maximal response
Progression free survival
Progression-free survival (PFS) will be defined as the time from registration until disease progression.
Time frame: Up to 1 year from time of maximal response
Duration of response
Time frame: Up to 1 year from time of maximal response
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.