Clinical Efficacy of MOAP Regimen for Relapsed/Refractory Classical Hodgkin's Lymphoma as a Rescue Therapy After Ineffective Treatment of Additional Low-dose Decitabine to Anti-PD-1 Antibody Camrelizumab
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- CRR assess by investigators per the 2014 Lugano classification
研究概览
简要总结
The DP regimen, low-dose decitabine combined with SHR-1210, is the new treatment for relapsed or refractory classical Hodgkin's Lymphoma. Though the CR rate of this regimen is impressively high, which is verified more than 70% in our I/II phase study, there are also lots of patients cannot benefit from this treatment. On top of that, as the increasing utilization of mono-therapy or combination treatment with the immune checkpoint blockade (ICB), the adverse reactions associated with immunotherapy make it unavailable in parts of patients. The application of MOAP regimen to patients, who have a progressive disease after DP regimen, can bring high CR rate. MOAP can be the a rescue treatment for cHL resisted to DP 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
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
- •13 to 70 years of age.
- •ECOG performance of less than
- •Life expectancy of at least 3 months.
- •Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
- •Subjects must have received at least two prior chemotherapy regimen and four cycle of DP regimen, and must be off therapy for at least 4 weeks prior to Day
- •Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
- •Subjects must have adequate marrow, live, renal and heart functions.
排除标准
- •Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- •Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- •Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
- •Prior organ allograft.
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- •Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
研究组 & 干预措施
MOAP treatment
Chlormethine Hydrochloride Injection 10mg d1,8 iv Vindesine Sulfate for Injection 4mg d1,8 iv Doxorubicin Hydrochloride Injection 25mg/m2 d1,8 iv Prednisone Acetate Tablets 1-1.5mg/kg/d d1-10 po 28 days/Cycle
干预措施: MOAP (Drug)
结局指标
主要结局
CRR assess by investigators per the 2014 Lugano classification
时间窗: 3 years
Time measured from the day of first documented PR or CR to the date of first rate of subjects achieved complete response in all evaluable subjects
duration of CR
时间窗: 5 years
Time measured from the day of first documented CR to the date of first documented progression, or death from any cause.
Number of Subjects with treatment-related adverse events (AEs)
时间窗: 2 years
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
次要结局
未报告次要终点
研究者
Han weidong
Principal Investigator
Chinese PLA General Hospital