Safety and Efficacy of Brentuximab Vedotin Maintenance After Allogeneic and Haploidentical Stem Cell Transplantation in High Risk CD30+ Lymphoma (Hodgkin Lymphoma and ALCL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Participants With Secondary Graft Failure
研究概览
简要总结
The goal of this clinical research study is to study the safety of ADCETRISTM (brentuximab vedotin) in patients with Hodgkin lymphoma or ALCL who have had an allogeneic or haploidentical stem cell transplant. Another goal of this study is to learn if brentuximab vedotin can help to prevent the disease from coming back.
详细描述
Study Drug Administration:
If you agree to take part in this study, about 35-60 days after the transplant, you will receive brentuximab vedotin by vein over about 30 minutes on Day 1 of each 21-day study cycle. You may receive up to 6 cycles of brentuximab vedotin.
At Cycles 3 and beyond, you will receive a higher dose of the study drug than you received during Cycles 1 and 2.
Study Visits:
About 5 days before Day 1 of Cycle 1:
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
- •Patients with CD30 positive Hodgkin Lymphoma (HL) or anaplastic large cell lymphoma (ALCL) that have undergone allogeneic or haploidentical SCT in the past 60 days (matched related or matched unrelated donors only).
- •Age 18 to 65 years.
- •Performance status: Zubrod 0-1 or Karnofsky 80-
- •Serum creatinine < 1.5 mg/dL or creatinine clearance greater than or equal to 40 cc/min as defined by MDRD method from National Kidney Disease Education Program (NKDEP).
- •Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome).
- •SGPT < 200 IU/L unless related to patient's malignancy.
- •Evidence of neutrophil and platelet engraftment, defined as platelet count equal or greater than 50,000 mm3 independent of platelet transfusion and ANC equal or greater to 1000 without growth factor support for at least 5 days.
- •Patients with previous exposure to brentuximab pre-transplant are eligible for the study.
排除标准
- •Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is post-menopausal with a positive serum pregnancy test.
- •Presence of steroid-refractory acute graft-versus-host disease (GVHD).
- •Patients that underwent allogeneic transplantation as a treatment of graft failure.
- •Dual refractory CMV reactivation to foscarnet and ganciclovir or evidence of CMV disease.
研究组 & 干预措施
Brentuximab Vedotin
Brentuximab by vein over 30 minutes every 3 weeks for a total of 6 cycles starting between days 30 and 60 post allogeneic stem cell transplant (SCT).
Brentuximab dose based on actual body weight starting with an initial dose of 1.2 mg/kg for the first 2 cycles and dose increased to 1.8 mg/kg after the second cycle for all subsequent cycles.
干预措施: Brentuximab Vedotin (Drug)
结局指标
主要结局
Number of Participants With Secondary Graft Failure
时间窗: An average of 12 months
Safety is defined by no more than two secondary graft failures within 6 months of transplant (Day 0), based on an observed graft failure rate of \<10% using standard of care treatment. If at any time more than two of these events are observed during the specified time frame, the study will be stopped and no further patients will be accrued.
次要结局
- Number of Participants With Hematologic Toxicity(an average of 12 months)
- Number of Participants With Central and Effector Cell Effects(an average of 12 months)
- Number of Participants With Relapse(an average of 12 months)
- Number of Participants With Acute Graft-versus-host Disease (GVHD).(an average of 12 months)
- Number of Participants With Incidence of Cytomegalovirus (CMV) Reactivation and/or CMV Disease.(an average of 12 months)
- Number of Participants With Change in Serum CD30 Levels After Brentuximab Administration(an average of 12 months)
- Number of Participants With Progression-Free Survival and Overall Survival on Brentuximab Maintenance(an average of 12 months)