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

• Status: Withdrawn
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acrotech Biopharma LLC; Spectrum Pharmaceuticals, Inc
• Treatments: Aminopterin; Leucovorin; Levoleucovorin

Criteria

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