A Phase 2, Single-Arm, Open-Label, Multicenter, Study of Folotyn® (Pralatrexate Injection) in Combination With Oral Leucovorin to Prevent or Reduce Mucositis in Patients With Hematological Malignancies Including PTCL and CTCL
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Grade 2 Oral Mucositis Prevention
研究概览
简要总结
This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.
详细描述
This is a Phase 2, single-arm, open-label, multicenter study to determine the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis in patients with hematological malignancies including PTCL and CTCL.
Patients with hematological malignancies, including PTCL and CTCL, will be enrolled based on meeting all protocol eligibility criteria. The primary endpoint will be evaluated in the first 7-week treatment cycle. For patients who respond to study treatment, the Investigator can treat patients for a total of 6 cycles. Approximately 37 patients will be enrolled. Safety, as assessed by reported SAEs, will continue to be monitored during the optional treatment period. Efficacy will be followed to the extent that it is evaluated according to the Institution's standard of care. No formal analysis of efficacy will be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient is diagnosed with hematological malignancies including PTCL and CTCL and are eligible for treatment with a dose of 30 mg/m^2
- •Patient is at least 18 years of age
- •Patient has been informed of the investigational nature of this study and has given written Informed Consent and is able to adhere to dosing and visit schedules and meet all study requirements
- •Patient has recovered from the toxic effects of prior therapy, and is at least 30 days from the most recent cytotoxic therapy, prior to enrollment
- •Patient has adequate hematologic, hepatic, and renal function as defined by:
- •ANC ≥1000/µL
- •Platelet count ≥100,000/µL
- •Total bilirubin ≤1.5 mg/dL
- •Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT), and gamma-glutamyltransferase (GGT) ≤2.5 xupper limit of normal (ULN) (AST/ALT/GGT ≤5 xULN if documented hepatic involvement with lymphoma)
- •Creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥50 mL/min
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Females of childbearing potential are to agree to practice a medically acceptable contraceptive regimen (including a barrier method) from study treatment initiation until at least 30 days after the last administration of Folotyn or leucovorin, whichever is last, and are to have a negative urine beta human chorionic gonadotropin (β-HCG) pregnancy test within 14 days prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as >12 months since last menses) or are surgically sterilized do not require this test
- •Male patients are to agree to use a barrier method of contraception from study treatment initiation until at least 90 days after the last administration of Folotyn
排除标准
- •Patient has congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification
- •Patient has uncontrolled hypertension
- •Patient has known, uncontrolled human immunodeficiency virus (HIV)-positive diagnosis
- •Patient has symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
- •Patient has an active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
- •Patient has had major surgery within 14 days prior to enrollment
- •Patient has used any investigational drugs, biologics, or devices within 14 days prior to study treatment or plans to use any of these during the course of the study
- •Patient has had previous exposure to Folotyn within 6 months of study enrollment
- •Patient is pregnant or breast-feeding
研究组 & 干预措施
Folotyn and Leucovorin
Folotyn will be administered by IV push at a dose of 30 mg/m2 once weekly for 6 weeks in each cycle, followed by 1 week of rest (no treatment).
Leucovorin (25 mg tablets) will be taken orally tid for 2 days for a total of six doses (150 mg cumulative weekly dose), beginning 24 hours after each dose of Folotyn is administered.
Folic acid and Vitamin B12 is given prior to initiation of Folotyn.
干预措施: Folotyn and Leucovorin (Drug)
Folotyn and Leucovorin
Folotyn will be administered by IV push at a dose of 30 mg/m2 once weekly for 6 weeks in each cycle, followed by 1 week of rest (no treatment).
Leucovorin (25 mg tablets) will be taken orally tid for 2 days for a total of six doses (150 mg cumulative weekly dose), beginning 24 hours after each dose of Folotyn is administered.
Folic acid and Vitamin B12 is given prior to initiation of Folotyn.
干预措施: Folic Acid (Drug)
Folotyn and Leucovorin
Folotyn will be administered by IV push at a dose of 30 mg/m2 once weekly for 6 weeks in each cycle, followed by 1 week of rest (no treatment).
Leucovorin (25 mg tablets) will be taken orally tid for 2 days for a total of six doses (150 mg cumulative weekly dose), beginning 24 hours after each dose of Folotyn is administered.
Folic acid and Vitamin B12 is given prior to initiation of Folotyn.
干预措施: Vitamin B12 (Drug)
结局指标
主要结局
Grade 2 Oral Mucositis Prevention
时间窗: 15 weeks
To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.
次要结局
- Effectiveness of Leucovorin in Folotyn dose modification(15 weeks)
- Grade 3 Oral Mucositis Prevention(15 weeks)
- Objective Response Rate(17 weeks)
- Grade 2 Oral Mucositis Duration of first occurrence(15 weeks)
- Grade 2 Oral Mucositis Duration(15 weeks)