Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn
- Registration Number
- NCT01789723
- Lead Sponsor
- Acrotech Biopharma Inc.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 5: Fusilev - 1 dose Folotyn Fusilev: 5 mg/m2 once on Day 2. Folotyn: 30 mg/m2 once weekly for 6 weeks Cohort 2: Fusilev - 6 doses Folotyn 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 Cohort 1: Fusilev - 10 doses Fusilev 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 Cohort 1: Fusilev - 10 doses Folotyn 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 Cohort 2: Fusilev - 6 doses Fusilev 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 Cohort 3: Fusilev - 4 doses Folotyn 5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose) and 3. Folotyn: 30 mg/m2 once weekly for 6 weeks Cohort 3: Fusilev - 4 doses Fusilev 5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose) and 3. Folotyn: 30 mg/m2 once weekly for 6 weeks Cohort 4: Fusilev - 2 doses Folotyn 5 mg/m2 BID, on Day 2 (24 ± 3 hours after Folotyn dose. Folotyn: 30 mg/m2 once weekly for 6 weeks Cohort 4: Fusilev - 2 doses Fusilev 5 mg/m2 BID, on Day 2 (24 ± 3 hours after Folotyn dose. Folotyn: 30 mg/m2 once weekly for 6 weeks Cohort 5: Fusilev - 1 dose Fusilev Fusilev: 5 mg/m2 once on Day 2. Folotyn: 30 mg/m2 once weekly for 6 weeks
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Relationship between Fusilev use and oral mucositis 7 weeks To determine the relationship between Fusilev use and oral mucositis as a function of the pretreatment homocysteine (HCY) and methylmalonic acid (MMA) levels
Impact of Fusilev on Folotyn related Oral Mucositis 7 weeks To determine the impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis To determine the impact of Fusilev on the frequency of Folotyn-related oral mucositis To determine the impact of Fusilev on the number of Folotyn doses delivered