Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn

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)

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.

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.

Inclusion Criteria:

• At least 18 years of age
• Patients with relapsed or refractory NHL who are eligible for Folotyn treatment. Patient has histologically/cytologically confirmed, measurable (lesion or node ≥ 2 cm by computed tomography [CT]
• Progressive disease or persistent disease after at least 1 prior treatment
• ECOG performance status ≤ 2
• Adequate hematological, hepatic, and renal function

Exclusion Criteria:

• Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix)
• Congestive heart failure
• Uncontrolled hypertension
• Known human immunodeficiency virus (HIV)-positive diagnosis
• Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
• Major surgery within 14 days of enrollment
• Pregnant or breast-feeding women
• Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
• Previous exposure to pralatrexate