EUCTR2014-003046-27-IT进行中（未招募）1 期
A PHASE II OPEN-LABEL SINGLE-CENTER STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF THE BRAF-V600 INHIBITOR VEMURAFENIB (ZELBORAF) IN COMBINATION WITH THE B-CELL TARGETING ANTIBODY RITUXIMAB (MABTHERA) IN PREVIOUSLY TREATED PATIENTS WITH HAIRY CELL LEUKEMIA (HCL) CARRYING THE BRAF-V600E MUTATIO
Dipartimento di Medicina0 个研究点目标入组 10 人开始时间: 2014年7月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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. Male or female HCL patients = 18 years of age.
- •2. Proven diagnosis of HCL according to the morphological and immunophenotypic criteria (co-expression of CD11c/CD25/CD103 and/or positivity for annexin-A1) of the World Health Organization (WHO-2008) classification of lymphoid neoplasms12, accompanied by the presence of the BRAF-V600E mutation as detected using a sensitive allele-specific polymerase chain reaction (AS-PCR) recently developed in our laboratory.
- •3. Patients with HCL must fall in one of the categories: i)Patients with HCL whose disease is refractory to therapy with purine analogues (no complete nor partial response, or relapse =1 year following treatment).
- •ii) Patients with HCL who relapse early (=1 year and =2 years) after the first course of a purine analogue (pentostatin or cladribine), or who relapse whenever after a second or later course. If the relapse is accompanied by bone marrow hypoplasia (<20% hematopoietic cells on histological analysis), which would advise against chemotherapy with a purine analogue, the patient is eligible even if the relapse occurs >2 years after the first course.
- •iii) Because in some studies persistence of residual disease is statistically associated with higher probability of relapse we consider eligible for the study also patients that, after at least two courses of therapy (at least one of which including a purine analogue), still manifest a significant residual disease in the bone marrow (=30% of leukemic hairy cells).
- •iiii)Patients with HCL who manifest severe side effects from therapy with purine analogues (prolonged and profound myelosuppression and immunosuppression, infectious complications, renal failure, vasculitis and autoimmune hemolytic anemia) or are deemed by the investigator medically unfit for chemotherapy with purine analogues (for example because of very old age and/or significant comorbidities).
- •4. Any prior treatment (chemotherapy and/or immunotherapy) must have been completed at least 12 weeks prior to initiation of study medication, except if no response to this treatment is already manifestly evident earlier.
- •5. ECOG PS of 0-2.
- •6. Patients must have recovered from all side effects of their most recent treatment for HCL.
- •7. Adequate renal and liver function as defined by the following laboratory values performed within 7 days prior to first dose of Vemurafenib and Rituximab: serum creatinine =2 times the upper limit of normal (ULN); serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =2.5 times ULN, alkaline phosphatase =2.5 times ULN and bilirubin =1.5 times the ULN. Higher values are acceptable if they are directly related to the disease.
- •8. Negative serum pregnancy test within 14 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for =1 year.
- •9. Fertile men and women must use an effective method of contraception during treatment and for at least 16 weeks (for men) and 12 months (for women) after completion of treatment as directed by their physician. Effective methods of contraception are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (for example implants, injectables, or intrauterine devices). Oral contraceptives are not reliable due to potential drug-drug interaction. At the discretion of the investigator, acceptable
排除标准
- •1. Patients with a previous malignancy within the past 2 years are excluded except for patients with treated and controlled basal or SCC of the skin or carcinoma in-situ of the cervix or melanoma (or other tumors) carrying a BRAF-V600E mutation. Isolated elevation in PSA in the absence of radiographic evidence of metastatic prostate cancer is allowed.
- •2. Patients with HCL previously treated with a BRAF inhibitor.
- •3. Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc.) other than those administered in this study and concurrent treatment on another therapeutic clinical trial.
- •4. Pregnant (negative serum pregnancy test is required in women of child-bearing potential) or lactating women.
- •5. Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption. Patients must be able to swallow tablets.
- •6. History of congenital long QT syndrome
- •7. Corrected QT (QTc) interval =500 msec at baseline or uncorrectable electrolyte abnormalities.
- •8. Active hepatitis infection or positivity for human immunodeficiency virus.
- •9. Uncontrolled medical illness.
- •10. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or which in the judgment of the investigator would make the patient inappropriate for entry into this study.
- •11. Unwillingness to practice effective birth control.
- •12. Inability to comply with other requirements of the protocol.
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