EUCTR2006-006694-24-DE进行中（未招募）不适用
Phase I/II dose-escalation study of the investigational trifunctional bispecific anti-CD20 x anti-CD3 antibody FBTA05 in relapsed or refractory chronic lymphocytic leukemia
Fresenius Biotech GmbH0 个研究点开始时间: 2007年1月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients will be enrolled in this study only if they meet all of the following criteria:
- •Signed and dated informed consent form.
- •Male or female
- •> = 18 years of age
- •Confirmed B-CLL based on standard histological or immunophenotypical criteria
- •described in the WHO classification of lymphoid malignancies
- •CD20+ (if not already confirmed)
- •Relapsed/refractory active disease after at least two prior treatments requiring
- •further therapy
- •Eastern Cooperative Oncology Group (ECOG) performance score of < = 2
- •Adequate hematological, liver and kidney function:
- •Platelet count > = 25,000/mm³ (= 25 x 10^9/l)
- •Serum glutamic oxaloacetic transaminase (SGOT/aspartate aminotransferase
- •[AST]) and serum glutamic pyruvate transaminase [SGPT]/alanine
- •aminotransferase [ALT]) < = 2.5 x upper limit of normal (ULN)
- •Total bilirubin < = 1.5 x ULN
- •Creatinine < = 1.5 x ULN
- •Negative pregnancy test (no more than 2 days before enrolment) and adequate
- •contraception during the study in women of child bearing potential
- •(pre-menopausal, < 2 years post-menopausal or not surgically sterile)
- •In addition, the following therapies must be discontinued at the given time points:
- •Alemtuzumab, Rituximab or autologous stem transplantation must be
- •discontinued at least 3 months prior to Visit 1
- •Any anti-cancer therapy must have been discontinued at least 4 weeks prior to
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will not be enrolled in this study if they meet any of the following criteria:
- •Women who are pregnant or breast feeding.
- •Known active HIV infection.
- •AIDS related lymphoma
- •Leptomeningeal involvement
- •Unable or unwilling to comply fully with the protocol
- •History of allogeneic stem cell transplantation
- •Second active malignant disease, currently requiring treatment (not including
- •basal cell carcinoma or curative surgery treated tumor)
- •Documented acute or chronic infection or other concurrent non-malignant
- •co-morbidities that are uncontrolled
- •Known or suspected hypersensitivity to recombinant/murine proteins
- •Any autoimmune disease
- •History of respiratory insufficiency
- •Patients participating in a concurrent clinical trial or treated with experimental
- •therapy within 30 days prior to the first administration of FBTA05
- •Clinical conditions equal to protocol definitions of DLT
- •Any condition which in the judgment of the Investigator would place the subject
- •at undue risk or interfere with the results of the study
- •Patients put into an institution by the authorities of judicial court
研究者
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