Status and phase
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About
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).
Full description
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.
Enrollment
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Inclusion criteria
Phase I: Patients must have histologically confirmed relapsed or refractory Non-Hodgkin's lymphoma, Hodgkin's Disease or multiple myeloma (defined by World Health Organization (WHO) criteria).
Phase II: Patients must have histologically confirmed relapsed or refractory T-Cell Lymphoma (as defined by WHO criteria).
Exclusion criteria
Prior Therapy
Central nervous system metastases, including lymphomatous meningitis
History of allergic reactions to Pralatrexate or Romidepsin
Uncontrolled intercurrent illness
Pregnant women
Nursing women
Current malignancy or history of a prior malignancy, as outlined in the protocol
Patient known to be Human Immunodeficiency Virus (HIV)-positive
Active Hepatitis A, Hepatitis B, or Hepatitis C infection
Primary purpose
Allocation
Interventional model
Masking
57 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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