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)

NCT01789723 Phase 1 WITHDRAWN

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.

Details

Lead sponsor	Acrotech Biopharma Inc.
Phase	Phase 1
Status	WITHDRAWN
Start date	2013-03
Completion	2015-03

Conditions

• Non Hodgkin's Lymphoma

Interventions

• Fusilev
• Folotyn

Primary outcomes

• Optimal dose and schedule of Fusilev to prevent or reduce mucositis — Up to 8 weeks
  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.