Phase II Trial Evaluating the Safety and Efficacy of Combined CD20- and BTK-Targeted B Cell Depleting Therapy With Rituximab and Ibrutinib in the Primary Treatment of Chronic Graft-Versus-Host Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The Number of Patients Who Remain Off Immunosuppressive Therapy at 12 Months After the Initiation of Treatment.
研究概览
简要总结
This is a phase II trial evaluating the safety and efficacy of the combination of Ibrutinib and Rituximab as primary treatment of chronic GVHD. We plan to enroll 35 patients on this study. Patients will be formally monitored monthly for 12 months to evaluate for outcome and safety endpoints. All other assessments will be done at the physician's discretion or institutional standards. All patients, responders and treatment failures, will be followed for a period of one year from the time of initiation of therapy. The primary endpoint will be the proportion of patients that are alive and off all systemic IST at 12 months following initiation of treatment.
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
- •First episode of systemic immunosuppression-requiring cGVHD, defined as classic or overlap cGVHD by the NIH consensus criteria.
- •Previously untreated cGVHD, defined by having received <10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD.
- •KPS 70% or greater
排除标准
- •Late persistent or recurrent acute GVHD
- •Active uncontrolled infection
- •History of HIV infection; active HBV or HCV infection
- •Inability to tolerate oral medications
- •Progressive or recurrent malignancy following allogeneic transplant
- •Exposure to BTK inhibitor following transplant
- •Received prior treatment with ECP for cGVHD
研究组 & 干预措施
Rituximab + Ibrutinib
Eligible patients will be those with a first episode of symptomatic cGVHD, requiring systemic immunosuppression for control of symptoms. Following study entry, patients will be started on rituximab plus ibrutinib.
干预措施: Rituximab (Drug)
Rituximab + Ibrutinib
Eligible patients will be those with a first episode of symptomatic cGVHD, requiring systemic immunosuppression for control of symptoms. Following study entry, patients will be started on rituximab plus ibrutinib.
干预措施: Ibrutinib (Drug)
结局指标
主要结局
The Number of Patients Who Remain Off Immunosuppressive Therapy at 12 Months After the Initiation of Treatment.
时间窗: 12 months following initiation of treatment
The primary objective is to evaluate the efficacy of the combination of rituximab and ibrutinib versus the historical experience with rituximab alone in the upfront treatment of cGVHD. Patients will be followed for 12 months following the initiation of treatment to see if they remain off immunosuppressive therapy.
次要结局
- The Number of Patients Who Respond to Treatment Assessed by NIH Response Criteria Working Group Report.(12 months following initiation of treatment)
- How Long it Takes for Patients to Discontinue Treatment Defined as the Date All Systemic Immunosuppressive Therapy is Discontinued After Resolution of GVHD.(Up to 32 months)
- How Many Patients Are Still Alive Without the Requirement for Second-line cGVHD Therapy Measured by Overall Survival at 12 Months Following the Initiation of Treatment.(12 months following initiation of treatment)
- How Many Patients Have Not Relapsed Measured by Progression-free Survival at 12 Months Following the Initiation of Treatment.(12 months following initiation of treatment)
- How Many Patients Have Not Died Measured by Overall Survival at 12 Months Following the Initiation of Treatment.(12 months following initiation of treatment)
- Number of Patients With Treatment-related Adverse Events Grade 3 or Greater as Assessed by CTCAE v.4.0.(12 months following initiation of treatment)
- Number of Patients With Treatment-related Adverse Events Total as Assessed by CTCAE v.4.0.(12 months following initiation of treatment)