Phase II Trial to Evaluate The Efficacy of Obinutuzumab (RO5072759) + Bendamustine Treatment in Patients With Refractory Or Relapsed Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 21
- 主要终点
- Overall Response Rate (ORR) as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria
研究概览
简要总结
This phase II trial was designed to evaluate the efficacy of obinutuzumab and bendamustine treatment in participants with refractory or relapsed chronic lymphocytic leukemia (CLL). Participants receive up to six 28-day cycles of treatment. Treatment consists of intravenous (IV) administration of obinutuzumab and bendamustine. Treatment time is expected to last 6 months, and participant follow-up will last 2 years.
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
- •Age 18 years or older
- •Diagnosed CD20+ B- chronic lymphocytic leukemia (CLL) according to National Cancer Institute (NCI) criteria
- •Active disease meeting at least 1 of the International Workshop on CLL (IWCLL) 2008 criteria for treatment
- •Refractory CLL (i.e. treatment failure or progression during treatment or within 6 months after the last treatment) or relapse CLL (i.e. participants who met criteria for CR or PR, but progressed beyond 6 months post-treatment)
- •At least 1 prior purine analogue or bendamustine containing therapy
- •Life expectancy greater than (>) 6 months
- •Use of effective contraception as described in the study protocol
排除标准
- •Prior Alogenic Bone Marrow Transplant
- •Greater than or equal to (>/=) 3 previous lines of chemotherapy and/or immunotherapy for the CLL
- •Previous obinutuzumab-containing regimen
- •Treatment failure or progression within 6 months of bendamustine-containing regimen
- •Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL; Richter's transformation) Patients with prolymphocytic transformation cannot entry the study either
- •Active haemolytic anaemia
- •Inadequate liver function
- •History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of malignancy that has been treated but not with curative intent will be excluded, unless the malignancy has been in remission without treatment for >/= 2 years prior to enrolment. Patients with a history of adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent are eligible
- •Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
- •Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
- •Regular treatment with corticosteroids during the 4 weeks prior to study start, unless administered for another condition at a dose equivalent to less than or equal to (</=) 30 milligrams per day (mg/day) prednisone
- •Known active infection or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to study start
- •Patients with HIV, human T cell leukemia virus 1 (HTLV-1), hepatitis B or hepatitis C
- •Pregnancy or breast-feeding
- •Vaccination with a live vaccine within 4 weeks prior to baseline visit
- •Receipt of any other study drug within 4 weeks prior to study start
研究组 & 干预措施
Obinutuzmab + Bendamustine
Participants will receive obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles
干预措施: bendamustine (Drug)
Obinutuzmab + Bendamustine
Participants will receive obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles
干预措施: obinutuzumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR) as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria
时间窗: 2-3 months after last dose of the study treatment (up to approximately 9 months)
ORR was defined as percentage of participants achieving Complete Response (CR), incomplete CR (CRi) or Partial Response (PR). CR: lymphocytes below 4 x 10\^9/L, absence of lymphadenopathy, hepatomegaly and splenomegaly, absence of disease or constitutional symptoms, neutrophils \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L, hemoglobin \> 110 g/L, bone marrow at least normocellular for age. CRi: CR with persistent cytopenia, i.e. anemia, thrombocytopenia and/or neutropenia. PR: reduction ≥ 50% of the lymphocyte count AND reduction ≥ 50% of the lymphadenopathy OR reduction ≥ 50% of the size of the liver if enlarged at baseline OR reduction ≥ 50% of the size of the spleen if enlarged at baseline PLUS one of the following: neutrophils \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L, hemoglobin \> 110 g/L or increase ≥ 50% compared to pre-treatment.
次要结局
- Overall Survival (OS)(From start of treatment up to death of any cause (up to approximately 4.5 years))
- Percentage of Participants With AEs of Special Interest (AESIs)(Up to approximately 4.5 years)
- Best Response Rate as Assessed by the Investigator Using the IWCLL 2008 Criteria(During study treatment and until 6 months after end of study treatment at approximately 12 months)
- Progression Free Survival (PFS)(From start of treatment up to disease progression or relapse or death, whichever occurred first (up to approximately 4.5 years))
- Event Free Survival (EFS)(From start of treatment up to disease progression or relapse or death or start of a new anti-leukemic therapy, whichever occurred first (up to approximately 4.5 years))
- Disease Free Survival (DFS)(From occurrence of complete response up to disease progression or death, whichever occurred first (up to approximately 4.5 years))
- Percentage of Participants With Infusion-related Reactions (IRRs)(Up to end of treatment at 6 months)
- Percentage of Participants Who Discontinued Treatment Prematurely(Up to end of treatment at 6 months)
- Duration of Response (DR)(From occurrence of CR or PR up to disease progression or death, whichever occurred first (up to approximately 4.5 years))
- Time to Re-treatment/New Anti-leukemia Therapy(Up to 4.5 years)
- Percentage of Participants With Minimal Residual Disease (MRD) Negativity(At approximately 9 months)
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to approximately 4.5 years)
- Percentage of Participants With Previous/Concomitant Diseases(Up to approximately 4.5 years)
- Percentage of Participants With Concomitant Medication(From 7 days prior to screening to the end of treatment at 6 months)