NCT03980002招募中2 期
A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With Chronic Lymphocytic Leukemia
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CRR
研究概览
简要总结
This is a prospective multicenter phase 2 study designed with the purpose to evaluate the response rate and safety of treatment with FCR/BR alternating with ibrutinib in treatment-naive patients with chronic lymphocytic leukemia.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥ 18 years and ≤ 75 of age.
- •Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria.
- •Treatment-naive patients. Those patients received short-term substandard treatment are permitted if meet all the items listed below:
- •Untreated with combined chemotherapy such as CHOP ,COP and so on.
- •Unteated with chemotherapy regimens including fludarabine and bendamustine.
- •Unteated with Ibrutinib.
- •If treated with chlorambucil or cyclophosphamide,should less than 3 weeks.
- •If treated with interferon, should less than 6 months.
- •No objective response are achieved (PR or CR).
- •CLL/SLL requiring treatment as defined by at least one of the following criteria:
- •Development of, or worsening of, anemia to Hb<100g/L (non-hemolytic) .
- •Development of, or worsening of, thrombocytopenia to PLT<100,000/L.
- •Massive (≥ 6 cm below left costal margin), progressive or symptomatic splenomegaly.
- •Massive nodes (≥ 10 cm in longest diameter), or progressive or symptomatic lymphadenopathy .
- •Progressive lymphocytosis with an increase of > 50% over a 2-month period or lymphocyte-doubling time of < 6 months. Lymphocyte-doubling time may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In patients with initial blood lymphocyte counts of < 30,000/L, LDT should not be used as a single parameter to define treatment indication. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL/SLL (eg, infection, use glucocorticoid) should be excluded. f)Symptomatic or functional extranodal sites involved s (eg. Skin,kidney, lungs and so on).
- •g)Constitutional symptoms, defined as any 1 or more of the following disease-related symptoms or signs: i. Unintentional weight loss of ≥ 10% within the previous 6 months ii.Significant fatigue (ie, inability to work or perform usual activities)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Expected to survival period for 3 months or more.
排除标准
- •History of malignant tumour except CLL in the past 1year(including active central nervous system (CNS) involvement with lymphoma).
- •Transformed to large cell lymphoma manifested by clinical evidence, or progressed to prolymphocytic leukemia(PLL).
- •Have active autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura, and require treatment.
- •Inadequate hepatic and renal function defined as: AST and ALT >4.0 x upper limit of normal (ULN), bilirubin >2.0 x upper limit of normal (ULN), Adequate renal function defined by serum creatinine >1.5 x upper limit of normal (ULN),unrelated to lymphoma.
- •Severe or uncontrolled infection.
- •Central nervous system (CNS) dysfunction with clinical manifestation.
- •Other serious medical diseases that may affect the study（eg. Uncontrolled diabetes, gastric ulcer, other severe cardiopulmonary disease),and final decided by the investigator.
- •Ongoing and uncontrolled bleeding
- •History of major life-threatening bleeding, especially due to irreversible cause.
- •Requirement for continuous anticoagulation drugs.
- •Major surgery within 30 days(excluding lymph node biopsy).
- •Pregnant or Lactating women, or women of reproductive age refusal to take contraceptive measures.
- •Allergy to any drug used in the study.
研究组 & 干预措施
FCR/BR alternating with ibrutinib
Experimental
FCR/BR→ ibrutinib✖️3months→FCR/BR→ ibrutinib✖️3months→FCR/BR→Maintenance therapy
干预措施: FCR and Ibrutinib (Drug)
FCR/BR alternating with ibrutinib
Experimental
FCR/BR→ ibrutinib✖️3months→FCR/BR→ ibrutinib✖️3months→FCR/BR→Maintenance therapy
干预措施: BR and Ibrutinib (Drug)
FCR/BR alternating with ibrutinib
Experimental
FCR/BR→ ibrutinib✖️3months→FCR/BR→ ibrutinib✖️3months→FCR/BR→Maintenance therapy
干预措施: Ibrutinib and Thalidomide (Drug)
结局指标
主要结局
CRR
时间窗: 3 months after completion of induction therapy
Rate of complete remission
次要结局
- DoR(5 years)
- ORR(3 months after completion of induction therapy)
- OS(5 years)
- PFS(5 years)
- MRD negative rate(3 months after completion of induction therapy)
- Treatment-related side effects(10 months)
研究者
TingyuWang
Attending doctor
Institute of Hematology & Blood Diseases Hospital, China
研究点 (1)
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