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Keep this study
Lead
Acrotech Biopharma Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn
