German Multicenter Phase II Trial to Study Effectivity and Feasibility of Alemtuzumab (MabCampath®) in T-ALL and T-Lymphoblastic Lymphomas With Minimal Residual Disease (MRD), in Refractory Relapse or in Primary Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Arm B: response (CR/PR/MR), toxicity according to CTC, SCT rate, remission duration/survival, feasibility of i.v. dose escalation/long term therapy, mortality
研究概览
简要总结
This study tests the effectivity and tolerability of treatment with alemtuzumab (MabCampath) in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma. In Arm A, patients with refractory relapse receive a 2 week treatment with MabCampath followed by remission evaluation. In case of insufficient response, treatment with cladribine is added. In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation. In both arms, treatment is continued in case of response for up to two months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •T-ALL or T-lymphoblastic lymphoma
- •CD52-expression > 20%
- •Aged >= 18 years
- •ECOG/World Health Organization (WHO) performance status 0-2
- •Life expectancy of > 2 months
- •Contraception during, and for at least 6 months after, therapy
- •At least a 2 week interval to the last cycle of chemotherapy (decision in individual cases if rapid progression)
- •No persistent toxicity from earlier cycles
- •Written informed consent
- •Evidence of MRD > 10(-4) with confirmation beyond week 16 in the GMALL-Study 07/2003
- •Relapse with failure to at least one salvage therapy or primary failure after induction therapy and at least one salvage therapy
排除标准
- •Substantial restrictions of heart, lung, liver, or kidney function
- •Active infection, HIV seropositivity or cytomegalovirus (CMV) viraemia
- •Pretreatment with MabCampath®
- •Known anaphylaxis to humanised antibodies
- •Permanent systemic therapy with corticosteroids
- •Central nervous system (CNS) involvement
- •Extramedullary bulky disease
- •Active secondary malignancies
- •Pregnancy or nursing
- •Mental disease or circumstances that prohibit compliance with the protocol procedures
研究组 & 干预措施
Arm A
In Arm A, patients with refractory relapse receive a 2 week treatment with MabCampath followed by remission evaluation. In case of insufficient response, treatment with cladribine is added.
干预措施: Alemtuzumab (MabCampath) (Drug)
Arm A
In Arm A, patients with refractory relapse receive a 2 week treatment with MabCampath followed by remission evaluation. In case of insufficient response, treatment with cladribine is added.
干预措施: Cladribine (Drug)
Arm B
In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation.
干预措施: Alemtuzumab (MabCampath) (Drug)
结局指标
主要结局
Arm B: response (CR/PR/MR), toxicity according to CTC, SCT rate, remission duration/survival, feasibility of i.v. dose escalation/long term therapy, mortality
时间窗: after 1 Cycle - approximately 3 weeks
Arm A: rate of molecular remissions (MRD < 10(-4), toxicity according to CTC, remission duration/survival, feasibility of s.c. dose escalation and long term therapy, mortality
时间窗: after 1 cycle - approximately 3 weeks
次要结局
未报告次要终点
研究者
Nicola Goekbuget
Head of GMALL
Goethe University