Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn
Non Hodgkin's Lymphoma
About this trial
This is an interventional prevention trial for Non Hodgkin's Lymphoma
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1: Fusilev - 10 doses
Cohort 2: Fusilev - 6 doses
Cohort 3: Fusilev - 4 doses
Cohort 4: Fusilev - 2 doses
Cohort 5: Fusilev - 1 dose
Fusilev: 5 mg/m2 QID, starting on Day 2 (24 ± 3 hours after Folotyn dose) for a total of 10 doses Day 2: 4 doses Day 3: 4 doses Day 4: 2 doses. Folotyn: 30 mg/m2 once weekly for 6 weeks
Fusilev: 5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose), 3, and 4. Folotyn: 30 mg/m2 once weekly for 6 weeks
5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose) and 3. Folotyn: 30 mg/m2 once weekly for 6 weeks
5 mg/m2 BID, on Day 2 (24 ± 3 hours after Folotyn dose. Folotyn: 30 mg/m2 once weekly for 6 weeks
Fusilev: 5 mg/m2 once on Day 2. Folotyn: 30 mg/m2 once weekly for 6 weeks