Efficacy of Short-course Blinatumomab in Patients with Detectable Measurable Residual Disease with Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy to eradicate MRD in negative Philadelphia-chromosome B-cell acute lymphoblastic leukemia
研究概览
简要总结
Detectable measurable residual disease (MRD) is the most important prognostic factor for B-cell acute lymphoblastic leukemia (B-ALL) for overall survival (OS) and disease-free survival (DFS). Patients who are MRD positive and have no access to novel immunotherapies should receive an allogeneic hematopoietic stem cell transplantation (HSCT). Blinatumomab is considered a standard of care (SOC) for this group of patients, however, the ideal treatment dose for MRD is unknown as doses were adjusted from the relapsed/refractory setting. Preliminary data suggest short cycles of blinatumomab can also be effective in states of lower disease burden prior to transplant. Thus, the investigators are performing a phase 2 trial assessing 7 days of blinatumomab as a bridge to HSCT
Primary endpoint is assessing the MRD response following a short-course blinatumomab infusion in patients with B-ALL with complete response (CR) and have detectable MRD disease who are candidates for HSCT. Secondary endpoints include incidence of adverse events, OS, DFS, percentage of patients who receive HSCT, incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS)
详细描述
During the proposed treatment, blinatumomab therapy will be assigned as follows:
Blinatumomab 17.5 mcg per day for 2 days, followed by blinatumomab 28 mcg per day for 5 days. Dexamethasone 20 mg will be applied one hour before starting dose.
The immunotherapy will be applied as a 24-hour continuous infusion. The scheduled appointments will be on the initial day of blinatumomab, when the patient will be discharged from hospital and evaluation will be performed on day 10 with bone marrow aspiration and MRD assessment trough next generation flow cytometry. The results will be given at the appointment on day 14, along with an assessment profile for HSCT.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia
- •MRD detectable in complete response (above the limit of quantification according to FCM)
- •Performance status 0-2 on the ECOG scale
- •No prior organ damage
- •Having a potential related or unrelated donor
排除标准
- •Performance status on the ECOG scale >2
- •HCT-CI >3 points
- •Patients who do not wish to participate in clinical study.
- •Active central nervous system infiltration (CNS3)
- •Active extramedullary disease
- •Having previously received blinatumomab
- •Absence of related or unrelated donors
研究组 & 干预措施
Blinatumomab arm
Patients will receive 7 days of blinatumomab with a fixed dose of 175 mcg through out 7 days
干预措施: Short course of blinatumomab (Drug)
结局指标
主要结局
Efficacy to eradicate MRD in negative Philadelphia-chromosome B-cell acute lymphoblastic leukemia
时间窗: 24 months
Primary outcome is to determinate the efficacy of blinatumomab to eradicate MRD in a blood sample extracted by bone marrow aspiration and evaluated by next generation flow cytometry on the third day after blinatumomab completion (day 10 after initiation). MRD eradication will be defined as: undetectable (below limit of detection) disease through next generation flow cytometry.
次要结局
- Percentage of patients undergoing stem cell transplantation(24 months)
- Incidence of adverse events(24 months)
- Incidence of cytokine release syndrome(24 months)
- Incidence of immune effector cell-associated neurotoxicity syndrome(24 months)
- Overall survival(24 months)
- Disease free survival(24 months)
研究者
David Gomez Almaguer
Head of Hematology
Hospital Universitario Dr. Jose E. Gonzalez