Low Dose Epcoritamab Plus Gemcitabine/Oxaliplatin in Treatment of Transplant Eligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Determine ORR and CR after GemOx plus low-dose Epcoritamab
研究概览
简要总结
In this study, researchers are looking to determine whether Gemcitabine/Oxaliplatin plus a lower dose of Epcoritamab (12 mg) works to treat subjects with relapsed/refractory diffuse large B-cell lymphoma, who are candidates to autologous stem cell transplantation.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with relapsed/refractory diffuse large B-cell lymphoma who have received at least 1 previous line of treatment and that are candidates to autologous stem cell transplant
- •Women of reproductive age who agree on getting a contraceptive method
- •Subjects who fulfill Lugano´s criteria for disease activity
- •Subjects who voluntarily accept to participate in this study
排除标准
- •Active bacterial, viral or fungal infection
- •Subjects who have already received an autologous o allogeneic stem cell transplantation
- •Subjects with other active neoplasias
- •Subjects with end-stage failure
研究组 & 干预措施
Epcoritamab + GemOx
Subjects will receive Gemcitabine/Oxaliplatin at usual doses as well as Epcoritamab with 2 step up doses followed by 12 mg weekly for 3 cycles.
干预措施: Epcoritamab (Drug)
Epcoritamab + GemOx
Subjects will receive Gemcitabine/Oxaliplatin at usual doses as well as Epcoritamab with 2 step up doses followed by 12 mg weekly for 3 cycles.
干预措施: Gemcitabine (1000 mg/m2) (Drug)
Epcoritamab + GemOx
Subjects will receive Gemcitabine/Oxaliplatin at usual doses as well as Epcoritamab with 2 step up doses followed by 12 mg weekly for 3 cycles.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Determine ORR and CR after GemOx plus low-dose Epcoritamab
时间窗: From enrollment to the end of treatment at 14 weeks
Determine ORR and CR after 3 cycles of GemOx plus low-dose Epcoritamab based on PET-CT
次要结局
- Establish feasibility(From enrollment up to day 29)
- Describe cytokine release syndrome incidence(From day 1 up to day 29)
- Describe immune effector cell- associated neurotoxicity syndrome incidence(From day 1 up to week 10)
- Describe adverse events(From day 1 up to week 10)
- Determine number of patients that follow through with transplant(From day one up through study completion, an average of 1 year)
- Duration of response(From week 18 through study completion, an average of 1 year)
- Progression free survival(From week 18 up to six and twelve months)
- Overall survival(From day 1 to twelve months)
研究者
Perla Rocío Colunga Pedraza
Associated professor
Hospital Universitario Dr. Jose E. Gonzalez