PDX-017: A Phase III Study of Pralatrexate Versus Observation in Patients with Peripheral T-Cell Lymphoma Following Initial Chemotherapy

Protocol
10-212
Full Title
PDX:017: A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients with Previously Undiagnosed Peripheral T-cell Lymphoma Who Have Achieved an Objective Response Following Initial Treatment with CHOP based Chemotherapy
Phase
III
Disease Status
Newly Diagnosed & Relapsed/Refractory
Purpose

Peripheral T-cell lymphoma is an aggressive disease requiring chemotherapy that often includes the drugs cyclophosphamide, doxorubicin, vincristine, and prednisone (a regimen abbreviated as CHOP). After initial chemotherapy, patients are usually observed and not treated again unless the disease comes back or gets worse.

Since initial chemotherapy usually only works for a short time, researchers are seeking ways to delay or avoid a recurrence or progression of disease. Pralatrexate is a new drug that has been approved for the treatment of T-cell lymphoma after it has returned or worsened after chemotherapy. In this study, researchers want to see if giving pralatrexate after initial therapy is completed (before disease progression has occurred) can prevent or delay a recurrence of T-cell lymphoma.

Patients in this study will be randomly assigned to receive pralatrexate or undergo observation.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have completed at least six cycles of chemotherapy (either CHOP or a similar regimen) for peripheral T-cell lymphoma and show no signs of disease progression.
  • Patients may not have had prior treatment with pralatrexate.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be at least 18 years of age.

For more information about this study and to inquire about eligibility, please contact Dr. Steven M. Horwitz at 212-639-3045.

Disease(s)
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
Locations
Related Diseases