A Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 主要终点
- Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
研究概览
简要总结
A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.
详细描述
This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in subjects with previously untreated CD20+ FL.
The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized, 2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting toxicity (DLT) within Part 1.
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
- 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
- •Diagnosis of CD20+, follicular lymphoma that has not been treated
- •CD20-immunophenotyping of tumor to document B-cell follicular lymphoma
- •Stage II disease with bulky disease (≥ 7cm lesion), Stage III, or Stage IV disease
- •Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF criteria)
- •At least one measurable lesion that is > 1.5 cm in at least one dimension
- •Eastern Cooperative Oncology Group (ECOG) performance status <=2 (corresponds to Karnofsky Performance Status [KPS] >=60%)
排除标准
- •Received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy.
- •Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B follicular lymphoma
- •Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
- •Prior allogeneic hematopoietic stem cell transplant
- •Prior, current or chronic hepatitis B or hepatitis C infection
- •Human immunodeficiency virus (HIV) infection or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection
研究组 & 干预措施
Duvelisib and Rituximab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
干预措施: Duvelisib (Drug)
Duvelisib and Rituximab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
干预措施: Rituximab (Drug)
Duvelisib and Obinutuzumab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
干预措施: Duvelisib (Drug)
Duvelisib and Obinutuzumab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
时间窗: 28 days from first dose of study treatment
Complete Response Rate (CRR)- Part 2
时间窗: Up to 2 years from the first dose of study treatment
次要结局
- Overall Response Rate (ORR)(Up to 2 years from the first dose of study treatment)
- Duration of Response (DOR)(Up to 2 years from the first dose of study treatment)
- Overall Survival (OS)(Up to 2 years from the first dose of study treatment)
- Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)(Every 4 weeks for 16 weeks)
- Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values(Up to 30 days after the last dose of study treatment)