Induction of Graft Versus Tumor Effect of Pegylated Interferon Alpha-2b for Patients With Relapsed Hematological Malignancies After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- response rate of Peg interferon alpha-2b
研究概览
简要总结
Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years, without vital organ dysfunction or ongoing graft-verus-host disease (GVHD).
Number of subjects: 50, Single center, one group, prospective. Drug: pegylated interferon alpha-2b (Peg Intron®; Schering-Plough) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments.
详细描述
Eligible patients were age 14 to 60 years with molecular, hematological or radiography relapsed hematological malignancies post allogeneic hematopoietic stem cell transplantation.
Molecular relapse was defined as reappearance or 1 log increase of molecular markers or decreasing donor chimerism by more than 5%; Hematological relapse was defined as reappearance of blast in bone marrow smear by more than 5%; radiography relapse was defined as enlargement of lymph nodes by more than 25% or infiltration of tumor cells in other sites.
Patients were excluded if they need immunosuppressant treatment for ongoing grade II～IV acute GVHD or moderate to severe chronic GVHD.
Eligible patients were treated with pegylated interferon alpha-2b (Peg Intron®; Schering-Plough (Brinny) Company, Innishannon, County Cork, Ireland) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments. Patients were followed up every week. Physical exams and blood tests including complete blood count (CBC), chemical were performed every week. Disease status evaluation was performed every month.
Number of subjects: 50 Single center, one group, prospective.
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
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14-60 years, male or female
- •Allo-HSCT recipients with malignant hematological diseases
- •Disease relapse after allo-HSCT, including hematological relapse, molecular relapse
- •Able to provide written informed consent and to comply with all study procedures
排除标准
- •Pregnant or nursing woman
- •Cardiac ejection factor < normal lower limit
- •Active acute or chronic GVHD with immunosuppressant treatment
- •Known hypersensitivity or allergy to interferon
- •Patient might develop serious complications according to investigator's experiences
- •Patient is undergoing other experimental medication
研究组 & 干预措施
Peg interferon alfa-2b
Pegylated Interferon α-2b (PEG INTRON®) , 1~1.5μg/kg qw, subcutaneous injection, 1 to 12 months, until occurrence of grade II or higher grade of acute graft versus host disease, or no response to treatment after 8 doses of treatments.
干预措施: Peg interferon alfa-2b (Drug)
结局指标
主要结局
response rate of Peg interferon alpha-2b
时间窗: 90 days
the percentage of patients acquiring complete remission and partial remission to Peg interferon alpha-2b in 90 days after treatment
次要结局
- overall survival after relapsing(one year)
- disease free survival after relapsing(one year)
研究者
Chun Wang
Director, department of Hematology
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine