This is a study to test how safe the combination of the drugs Romidepsin and Pralatrexate are in patients with lymphoid malignancies and to determine the dose of the combination of drugs that is safest. If the combination is determined to be safe, the study will continue accrual patients with peripheral T-Cell lymphoma (PTCL).
The non- Hodgkin lymphomas (NHL) represent a heterogeneous group of malignancies. Under the rubric of lymphoma exist some of the fastest growing cancers known to science, (Burkett's lymphoma, lymphoblastic lymphoma/leukemia), as well as some of the most indolent (small lymphocytic lymphoma, follicular lymphoma, and marginal zone lymphoma). This remarkable diversity of biology imposes significant challenges. Researchers are seeking to understand the cell of origin and differentiate what are sometimes subtle differences between the related sub-types of disease; and to identify the best treatments for these subtypes, with the ever-increasing likelihood that new understanding of the molecular pathogenesis of these diseases will result in an increase in new drugs for specific target populations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Phase I - Schedule A: Intravenous drug given on days 1 and 8 of each 21 day cycle Schedule B: Intravenous drug given on days 1 and 15 of each 28 day cycle Dose escalation from 10 mg/m2 to 25 mg/m2 Phase II - 25 mg/m2 will be given intravenously once weekly on days 1 and 15 on a 28 day cycle.
Phase I - Schedule A: Intravenous drug given on days 1 and 8 of each 21 day cycle Schedule B: Intravenous drug given on days 1 and 15 of each 28 day cycle Dose escalation from 12 mg/m2 to 14 mg/m2. Phase II - 12 mg/m2 will be given intravenously once weekly on days 1 and 15 on a 28 day cycle.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Columbia University Irving Medical Center
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Maximum tolerated dose (MTD) of the combination of pralatrexate and romidepsin
For Phase I
Time frame: Up to 1.5 years
Overall response rate (ORR) (complete + partial response) of the combination of pralatrexate and romidepsin in patients with relapsed/refractory T-Cell Lymphoma
For Phase II
Time frame: Up to 3 years
Maximum number of cycles received
For Phase II
Time frame: Up to 1.5 years
Number of dose delays at the MTD
For Phase I
Time frame: Up to 1.5 years
Overall response rate (ORR) of the study population
For Phase I
Time frame: Up to 1.5 years
Duration of response (DOR) of the combination in patients with T-Cell Lymphoma
For Phase II
Time frame: Up to 3 years
Overall survival (OS) of patients with T-Cell Lymphoma on study
For Phase II
Time frame: Up to 3 years
Progression free survival (PFS) of the combination in patients with T-Cell Lymphoma
For Phase II
Time frame: Up to 3 years
Number of dose reductions at the MTD
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For Phase I
Time frame: Up to 1.5 years
Progression free survival (PFS) of the study population
For Phase I
Time frame: Up to 1.5 years
Duration of response (DOR) of the study population.
For Phase I
Time frame: Up to 1.5 years