An Open Label, Multicenter, Dose Finding, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Receiving Folotyn® (Pralatrexate)
This is an open label, uncontrolled, nonrandomized, multicenter, dose finding, Phase 1 study
primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce
Folotyn-related Grade 3 or higher oral Mucositis.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Optimal dose and schedule of Fusilev to prevent or reduce mucositis
The patient will be seen in the clinic for an oral mucositis assessment at baseline. During the 6 weeks of Folotyn treatment, oral mucositis assessment will be performed weekly prior to each Folotyn dose and again on Day 4 (prior to the Fusilev dose when applicable) by a qualified health care professional. Patients will complete an Oral Mucositis Daily Questionnaire (OMQD) starting at Day 1 of Week 1 and ending at the End of Treatment Visit.
Up to 8 weeks
Ahmed Sawas, MD
United States: Food and Drug Administration