NCT04434937已完成2 期
A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 30
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female Japanese participant who must be ≥ 18 years of age
- •Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures
- •Histologically confirmed, relapsed or refractory, FL Grade 1, 2, and 3a
- •Ineligible for HSCT
- •Must have been treated with at least 2 prior systemic therapies for FL
- •Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the LD and ≥ 1.0 cm in the LPD, respectively) as assessed by CT or MRI
- •Participants must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy collected after the completion of last therapy. An earlier archived lymph node or tissue biopsy is acceptable if hospitalization is required for biopsy (eg. no superficial lymph node) and SUVmax by FDG-PET is < 14
- •ECOG performance status 0 to 2
- •Life expectancy ≥ 12 weeks
- •Adequate hematologic, hepatic, and renal functions ANC ≥ 1.0 × 109/L Hemoglobin ≥ 8.0 g/dL. Platelet count ≥ 50 × 109/L. Total bilirubin ≤ 1.5 × ULN. Participants with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible.
- •ALT/AST ≤ 2.5× ULN or ≤ 5 × ULN in the presence of liver involvement. Calculated creatinine clearance ≥ 40 mL/min by the Cockcroft-Gault Equation or the estimated glomerular filtration rate ≥ 40 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula.
- •Female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration.
- •Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study.
- •Male participants should avoid fathering children from screening through at least 93 days after the last dose of study treatment.
排除标准
- •Known histological transformation from indolent NHL to DLBCL
- •History of central nervous system lymphoma (either primary or metastatic)
- •Prior treatment with the following:
- •Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib, etc).
- •Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
- •Allogeneic SCT within the last 6 months, or autologous SCT within the last 3 months before the date of study treatment administration
- •Active graft-versus-host disease
- •Use of immunosuppressive therapy within 28 days of the date of study treatment administration
- •Concurrent anticancer therapy
- •Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease
- •Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
- •Hepatitis B (HBV) or HCV infection
- •Current New York Heart Association Class II to IV congestive heart failure or uncontrolled arrhythmia
研究组 & 干预措施
parsaclisib
Experimental
parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits
干预措施: parsaclisib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to approximately 3 years
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as defined by revised response criteria for lymphoma, as determined by an Independent Review Committee (IRC). CR: target nodes/nodal masses regressed to ≤1.5 centimeters (cm) in the longest transverse diameter (LDi); no nonmeasured lesions; regression to normal for organ enlargement; no new lesions; and normal bone marrow by morphology and negative immunohistochemistry if indeterminate. PR: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites; absent/regressed nonmeasured lesions (but no increase); spleen regressed by \>50% in length beyond normal; and no new lesions.
次要结局
- Complete Response Rate (CRR)(up to approximately 3 years)
- Duration of Response (DOR)(up to 20.0 months)
- Progression-free Survival (PFS)(up to approximately 3 years)
- Overall Survival(up to approximately 3 years)
- Best Percentage Change in Target Lesion Size From Baseline, as Determined by Independent Review Committee and the Investigator(up to approximately 3 years)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to 1041 days)
- Number of Participants With Any Grade 3 or Higher TEAE(up to 1041 days)
研究者
研究点 (30)
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