Dosing study: Fusilev for treating mucositis in Folotyn patients

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Phase 1 Study ->http://www.clinicaltrials.gov/ct2/show/NCT01789723?term=folotyn+mucositis&rank=1

The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.

Primary Outcome Measures:

• Optimal dose and schedule of Fusilev to prevent or reduce mucositis [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
  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.

Secondary Outcome Measures:

• Impact of Fusilev on Folotyn related Oral Mucositis [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
  To determine the impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis To determine the impact of Fusilev on the frequency of Folotyn-related oral mucositis To determine the impact of Fusilev on the number of Folotyn doses delivered
• Relationship between Fusilev use and oral mucositis [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
  To determine the relationship between Fusilev use and oral mucositis as a function of the pretreatment homocysteine (HCY) and methylmalonic acid (MMA) levels

Other Outcome Measures:

• Overall Response Rate (ORR) [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
  To determine overall response rate (ORR) of Folotyn in relapsed or refractory Non-Hodgkin's lymphoma other than PTCL
  
  

Estimated Enrollment:	75
Study Start Date:	March 2013
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)