EUCTR2012-004027-20-DE进行中（未招募）1 期
A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects with Relapsed / Refractory or Previously Untreated Chronic Lymphocytic Leukemia Harboring the 17p Deletion
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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. Subject must be = 18 years of age
- •2. Subject must have diagnosis of CLL that meets published 2008 Modified IWCLL NCI-WG Guidelines.
- •Subject has an indication for treatment according to the 2008 Modified IWCLL NCI-WG Guidelines;
- •Subject has clinically measurable disease;
- •Subject must have relapsed/refractory CLL or previously untreated CLL;
- •- Refractory or relapsed CLL subjects must meet the following requirements:
- •Refractory or relapsed after receiving at least one prior line of therapy (subjects that have progressed after 1 cycle of treatment or have completed at least 2 cycles of treatment for a given line of therapy);
- •- Previously untreated CLL subjects must meet the foloowing requirements (previously untreated chronic lymphocytic leukemia harboring 17p deletion patients will not be enrolled in Germany):
- •Received no prior chemotherapy or immunotherapy. subjects with a history of emergency, loco-regional radiotherapy (e.g., for relief of compressive signs or symptoms) are eligible.
- •CLL diagnostic criteria above and must have > 5 x 109/L B-Lymphocytes in the peripheral blood.
- •Subjects must have 17p deletion, assessed by local laboratory (in bone marrow or peripheral blood) or assessed by central laboratory (peripheral blood)
- •3. Subject has an ECOG performance score of = 2
- •4. Subjects must meet the following laboratory parameters, per laboratory reference range: ANC = 1000/µL-For subjects with an ANC < 1000/µL at Screening and bone marrow heavily infiltrated with underlying disease (unless cytopenia is clearly due to marrow involvement of CLL), G-CSF may be administered after Screening and prior to the first dose of venetoclax to achieve the ANC eligibility criteria (= 1000/µL); Platelet count > 40,000 mm3, (independent of
- •transfusion within 14 days of screening); aPTT and PT = 1.5 × ULN; Hemoglobin = 8.0 g/dL; AST and ALT = 3 × ULN; Calculated creatinine clearance> 50 mL/min; Total bilirubin = 1.5 × ULN (Subjects with Gilbert's Syndrome may have bilirubin > 1.5 × ULN per correspondence between the investigator and AbbVie medical monitor).
- •5. For high risk subjects a pre approval by the AbbVie medical monitor is required prior to enrollment.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Subject has undergone an allogeneic stem cell transplant
- •2. Subject has developed Richter's transformation (confirmed by biopsy).
- •3. Subject has prolymphocytic leukemia
- •4. Subject has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to screening), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP) despite low dose corticosteroids
- •5. Subject is known to be positive for HIV due to potential drug-drug interactions as well as anticipated mechanism-based lymphopenia that may increase the risk of opportunistic infections.
- •6. Subject has received the following within 30 days prior to the first dose of study drug:
- •-A biologic agent (i.e., monoclonal antibodies) for anti-neoplastic intend.
- •7. Subject has received radiotherapy within 14 days or any of the follwoing within 14 days or 5 half-lives as applicable prior to the first dose of study drug, or has not recovered to less than CTC grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
- •-Any anti-cancer therapy including chemotherapy, or radiotherapy;
- •-Investigational therapy, including targeted small molecule agents.
- •8. Subject has known allergy to both xanthine oxidase inhibitors and rasburicase.
- •9. Cardiovascular disability status of New York Heart Association Class =2.
- •10. 4. Exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to:
- •-uncontrolled systemic infection (viral, bacterial, or fungal).
- •-Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment.
- •-Febrile neutropenia
- •11. Subject has a significant history of renal, pulmonary, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study. For subjects who have required an intervention for any above diseases within the past 6 months a correspondence with the investigator and the AbbVie medical monitor must occur.
- •12. Subject has a significant history of other active malignancies other than CLL within the past 3 years prior to study entry, with the following exceptions: Adequately treated in situ carcinoma of the cervix uteri; Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
研究者
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