EUCTR2005-005074-69-CZ进行中（未招募）1 期
Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH, MabCampath) in Patients with Previously Treated B Cell Chronic Lymphocytic Leukemia
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 85
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
- •(1) A diagnosis of B-CLL; according to the NCIWG Criteria (Appendix D)
- •(2) At least 18 years old
- •(3) World Health Organization (WHO) performance status of 0, 1, or 2
- •(4) Life expectancy =12 weeks
- •(5) Previous therapy with at least one but no more than 5 regimens (single agent or combination regimen). One regimen is defined as consecutive, contiguous cycles of the same drug(s) with no treatment interruptions lasting > 3 months
- •(6) Patient requires treatment for chronic lymphocytic leukemia (CLL) per the following criteria
- •*Rai stage III or IV (Appendix D).
- •* Rai stage 0-II with at least one of the following:
- •- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
- •- Massive (i.e., >6 cm below the left costal margin) or progressive splenomegaly
- •- Progressive lymphocytosis with an increase of >50% over a 2 month period or an anticipated doubling time of <6 months
- •- Lymphocyte count >100×109/L
- •- B symptoms
- •(7) More than 3 weeks since prior chemotherapy. Patient must have recovered from the acute side effects incurred as a result of previous therapy.
- •(8) More than 3 weeks since using investigational agents. Patient must have recovered from the acute side effects incurred as a result of previous therapy.
- •(9) Serum creatinine and conjugated (direct) bilirubin =2 x the institutional upper limit of normal (ULN) unless secondary to direct infiltration of the liver with CLL.
- •(11) Female patients with childbearing potential must have a negative pregnancy test (serum or urine) within 2 weeks of first dose of study drug(s). All patients must agree to use an effective contraceptive method while on study treatment, if appropriate, and for a minimum of 6 months following study therapy.
- •(12) Signed, written informed consent
- •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
- •(1) Positive Coombs test and evidence of active hemolysis
- •(2) Platelet count <50 ×109/L without splenomegaly
- •(3) History of anaphylaxis following exposure to rat or mouse derived CDR grafted humanized monoclonal antibodies
- •(4) Previously treated with CAMPATH
- •(5) Previous bone marrow transplant
- •(6) Known central nervous system (CNS) involvement with B-CLL
- •(7) Active infection, including human immunodeficiency virus (HIV) positive
- •(8) Active secondary malignancy
- •(9) Recent documented history (within 2 years) of active tuberculosis (TB), current active TB infection, currently receiving anti-tuberculous medication (e.g., isoniazid, rifampin, streptomycin, pyrazinamide, or others)
- •(10) Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive hepatitis B serologies. Patients with a positive hepatitis B surface antibody (HBsAb) test with a documented history of prior hepatitis B immunization are eligible as long as other criteria are met (ie, negative tests for: hepatitis B surface antigen [HBsAg], hepatitis B core antibody [HBcAb] and hepatitis C virus antibody [HCVAb]).
- •(11) Other severe, concurrent diseases (e.g., cardiac or pulmonary disease), mental disorders, or major organ malfunction (liver, kidney) that could interfere with the patient’s ability to participate in the study
- •(12) Pregnant or nursing women
- •(13) Cytomegalovirus (CMV) positive by polymerase chain reaction (PCR) (above the level of detection). A patient that is PCR positive will require treatment to reduce the viral load to a non-detectable level, but such a patient may be reconsidered for study entry once the infection has been treated (see Section 6.1.1).
- •(14) Medical condition requiring chronic use of oral cortocosteroids at a dose higher than physiologic replacement.
研究者
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