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In a Phase II clinical trial, 27% of patients with relapsed or refractory peripheral T-cell lymphoma (a type of non-Hodgkin?s lymphoma) experienced a complete or partial disappearance of detectable cancer following treatment with the investigational drug pralatrexate. These results were presented at the 50th Annual Meeting of the American Society of Hematology.

Peripheral T-cell lymphoma (PTCL) is a relatively uncommon type of non-Hodgkin?s lymphoma. The optimal approach to the treatment of PTCL remains uncertain, and the prognosis for many patients is poor.

Pralatrexate is an investigational antifolate drug. The drug is thought to accumulate in cancer cells, interfere with DNA synthesis, and trigger cell death.

To evaluate pralatrexate in the treatment of PTCL, researchers conducted a Phase II clinical trial known as PROPEL (Pralatrexate in patients with Relapsed OR refractory PEripheral T-cell Lymphoma). The study enrolled 115 patients with PTCL that had returned after previous treatment or that was resistant to previous treatment.

Study participants received intravenous (IV) pralatrexate in addition to vitamin B12 and folic acid supplementation.

The primary outcome of interest was response to treatment. A complete response refers to the complete disappearance of detectable cancer, and a partial response refers to a reduction in the amount of detectable cancer.

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Information about 109 patients was available for analysis.

  • 27% of patients experienced a complete or partial response to treatment. 10% of patients (11 out of 109) had a complete response.17% of patients (18 out of 109) had a partial response.

The patients in this study will continue to be followed, but these results suggest that pralatrexate is active against relapsed or refractory PTCL.

Patients with PTCL may wish to talk with their doctor about the risks and benefits of participating in a clinical trial further evaluating this or other novel therapeutic approaches. Information about ongoing clinical trials is available at*?*or

Reference: O?Connor OA, Pro B, Pinter-Brown L et al. PROPEL: a multi-center phase 2 open-label study of pralatrexate (PDX) with vitamin B12 and folic acid supplementation in patients with relapsed or refractory peripheral T-cell lymphoma. Presented at the 50th Annual Meeting of the American Society of Hematology, San Francisco, CA, December 6-9, 2008. Abstract 261.

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