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)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Optimal dose and schedule of Fusilev to prevent or reduce mucositis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort 1: Fusilev - 10 doses
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
干预措施: Fusilev (Drug)
Cohort 1: Fusilev - 10 doses
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
干预措施: Folotyn (Drug)
Cohort 2: Fusilev - 6 doses
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
干预措施: Fusilev (Drug)
Cohort 2: Fusilev - 6 doses
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
干预措施: Folotyn (Drug)
Cohort 3: Fusilev - 4 doses
5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose) and 3.
Folotyn: 30 mg/m2 once weekly for 6 weeks
干预措施: Fusilev (Drug)
Cohort 3: Fusilev - 4 doses
5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose) and 3.
Folotyn: 30 mg/m2 once weekly for 6 weeks
干预措施: Folotyn (Drug)
Cohort 4: Fusilev - 2 doses
5 mg/m2 BID, on Day 2 (24 ± 3 hours after Folotyn dose.
Folotyn: 30 mg/m2 once weekly for 6 weeks
干预措施: Fusilev (Drug)
Cohort 4: Fusilev - 2 doses
5 mg/m2 BID, on Day 2 (24 ± 3 hours after Folotyn dose.
Folotyn: 30 mg/m2 once weekly for 6 weeks
干预措施: Folotyn (Drug)
Cohort 5: Fusilev - 1 dose
Fusilev: 5 mg/m2 once on Day 2.
Folotyn: 30 mg/m2 once weekly for 6 weeks
干预措施: Fusilev (Drug)
Cohort 5: Fusilev - 1 dose
Fusilev: 5 mg/m2 once on Day 2.
Folotyn: 30 mg/m2 once weekly for 6 weeks
干预措施: Folotyn (Drug)
结局指标
主要结局
Optimal dose and schedule of Fusilev to prevent or reduce mucositis
时间窗: 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.
次要结局
- Relationship between Fusilev use and oral mucositis(7 weeks)
- Impact of Fusilev on Folotyn related Oral Mucositis(7 weeks)