A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
A study to evaluate the safety and efficacy of duvelisib administered in combination with rituximab vs placebo in combination with rituximab in patients with previously treated CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.
详细描述
Study IPI-145-08 is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of duvelisib in combination with rituximab vs placebo in combination with rituximab in subjects with previously treated CD20-positive follicular lymphoma.
Approximately 400 subjects will receive 25 mg of duvelisib or placebo, orally BID for 28 day continuous cycles, in combination with 375 mg/m2 of Rituximab given once weekly for 4 weeks during Cycle 1 and then once on Day 1 of Cycles 4, 6, 8, and 10. Patients will remain on treatment for up to 27 cycles and may continue treatment if clinical benefit is observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of CD20-positive FL:
- •Histology grades 1, 2 or 3a
- •Biopsy-confirmed histopathological diagnosis of FL. Biopsy specimen should be obtained ≤2 years prior to randomization, unless medically contraindicated
- •CD20 immunophenotyping performed ≤2 years prior to randomization
- •First or subsequent relapse following at least one induction therapy regimen containing rituximab in combination with an anthracycline or rituximab in combination with an alkylating agent
- •Patients in first relapse must be chemoresistant or intolerant to chemotherapy
- •No response or disease progression ≤ 24 months from start of last previous therapy
- •At least 1 measurable disease lesion >1.5 cm in at least one diameter by CT/CT-PET or magnetic resonance imaging (MRI) in an area of no prior radiation therapy, or in an area that was previously irradiated that has documented progression
排除标准
- •Clinical evidence of other indolent forms of lymphoma (e.g., marginal zone lymphoma [MZL], small lymphocytic lymphoma [SLL])
- •Transformation to a more aggressive subtype of lymphoma or grade 3b FL
- •Refractory to rituximab: defined as disease progression while receiving or within 6 months of completing either weekly rituximab induction therapy, or rituximab-based chemoimmunotherapy induction
- •Intolerance to rituximab or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibodies
- •Prior allogeneic hematopoietic stem cell transplant (HSCT)
- •Known Central Nervous System (CNS) lymphoma; subjects with symptoms of CNS disease must have a negative CT scan and negative diagnostic lumbar puncture
- •Prior treatment with a PI3K inhibitor or BTK inhibitor
- •History of tuberculosis within the preceding two years
- •Ongoing systemic bacterial, fungal, or viral infections at randomization (defined as requiring IV antimicrobial, antifungal or antiviral agents)
- •Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other I/E criteria are met
- •Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C virus antibodies (HCV Ab)
- •History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
研究组 & 干预措施
Duvelisib + Rituximab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
干预措施: Duvelisib (Drug)
Duvelisib + Rituximab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
干预措施: Rituximab (Drug)
Placebo + Rituximab
Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
干预措施: Placebo (Drug)
Placebo + Rituximab
Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
干预措施: Rituximab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Until disease progression, for up to 5 years from randomization
Due to the small number of enrolled subjects and study being terminated, PFS endpoint analysis was not performed.
次要结局
- Overall Response Rate (ORR)(Until disease progression, for up to 5 years from randomization)