MT2022-60: A Phase II Study of Pembrolizumab+ BEAM Conditioning Regimen Before Autologous Stem Cell Transplant (ASCT) Followed by Pembrolizumab Maintenance in Patients of Relapsed or Refractory Classic Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
- Eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen
- KPS greater than 70 or ECOG ≤ 1
- Adequate organ function and blood counts within 14 days of study registration
- Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
- Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
- HIV-infected participants must have well-controlled HIV on ART
排除标准
- Patients with prior history of any grade 2 or higher autoimmune reaction to PD-1 inhibitors, necessitating permanent discontinuation of the PD-1 inhibitor or necessitating systemic immunosuppressants.
- Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Has received any chemotherapy within 3 weeks prior to the first dose of study intervention
- Has known active CNS disease.
- History of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents. Exceptions: Participants with vitiligo, resolved childhood asthma or atopy, hypothyroidism, or Sjogren's syndrome, as well as participants requiring only intranasal steroids, intermittent use of bronchodilators, local steroid injections, or physiologic replacement doses of prednisone (≤ 10 mg/d) may enroll.
- Has had an allogenic tissue/solid organ transplant.
- Pregnant or breastfeeding as agents used in this study are Pregnancy Category D (positive evidence of risk). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days of study registration
研究组 & 干预措施
Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.
Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
干预措施: Carmustine (Drug)
Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.
Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
干预措施: Cytarabine (Drug)
Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.
Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
干预措施: Autologous stem cell transplant (Procedure)
Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.
Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
干预措施: Melphalan (Drug)
Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.
Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
干预措施: Pembrolizumab (Drug)
Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.
Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
干预措施: Etoposide (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: Baseline to 1 year post-ASCT
Number of participants with progression free survival at 1 year post transplant. Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive.
次要结局
- Overall Survival (OS)(Baseline to 5 year post-ASCT)
- Overall survival (OS)(Baseline to 2 years post-ASCT)
- Progression-free survival (PFS)(Baseline to 2 years post-ASCT)
- Non-relapse mortality (NRM)(Day 100 post-ASCT)
- Overall Survival (OS)(Baseline to 5 year post-ASCT)
- Overall survival (OS)(Baseline to 2 years post-ASCT)
- Progression-free survival (PFS)(Baseline to 2 years post-ASCT)
- Non-relapse mortality (NRM)(Day 100 post-ASCT)
- Complete Radiologic Response Rate(Day 28)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT06377540
- 其他研究编号
- 2022LS174
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (11个月后)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否