Clinical Trial: Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Open-label Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

Brief Summary: This study is being conducted to identify how much and how often pralatrexate, given with vitamin B12 and folic acid, can be given safely to patients with cutaneous T-cell lymphoma (CTCL) that has relapsed (returned after responding to previous treatment) or is refractory (has not responded to previous treatment). It is also being conducted to get information on whether or not pralatrexate is effective in treating relapsed or refractory CTCL.

Detailed Summary:
Sponsor: Spectrum Pharmaceuticals, Inc

Current Primary Outcome: Determine an Effective and Well-tolerated Dose and Schedule of Pralatrexate with Vitamin B12 and Folic Acid Supplementation for Patients with Relapsed or Refractory Cutaneous T-cell Lymphoma (CTCL) [ Time Frame: Assessed at the end of every even-numbered cycle (every 8 weeks) for the first 6 months, then every 4 cycles (16 weeks) ]

Original Primary Outcome: To determine an effective and well-tolerated dose and schedule of pralatrexate with vitamin B12 and folic acid supplementation that can be administered safely to patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). [ Time Frame: Study duration ]

Current Secondary Outcome: Characterize the Safety Profile of Pralatrexate in Patients with Relapsed or Refractory CTCL. [ Time Frame: Assessed at all study visits: weekly while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal) ]

Original Secondary Outcome: To characterize the safety profile of pralatrexate in this group of patients. [ Time Frame: Study duration ]

Information By: Spectrum Pharmaceuticals, Inc

Dates:
Date Received: November 5, 2007
Date Started: August 2007
Date Completion:
Last Updated: May 8, 2013
Last Verified: May 2013