According to the final results of 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; the median duration of response was over nine months.

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.

  • 29 of the 109 patients (27%) experienced a complete or partial response to treatment. Nine of these responses were complete and 20 were partial.
  • The median duration of response was 9.4 months.
  • The most common serious (grade 3 or 4) adverse effects of treatment were thrombocytopenia (32% of patients), mucosal inflammation (21% of patients), neutropenia (20% of patients), and anemia (17% of patients).

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: Allos Therapeutics, Inc. Press release. Allos Therapeutics Announces Final Results from Pivotal PROPEL Trial of Pralatrexate in Patients with Peripheral T-cell Lymphoma. February 3, 2009.

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