EUCTR2012-004027-20-FR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 or Refractory 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
- 100
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 IWCLL NCI-WG criteria.
- •Subject has an indication for treatment according to the 2008 IWCLL NCI-WG criteria;
- •Subject has clinically measurable disease;
- •Subject must have relapsed or be refractory after receiving at least one prior line of therapy (a line of therapy is defined as completing at least 2 cycles of treatment for a given line of therapy);
- •Subjects must have 17p deletion, assessed by central laboratory, and determined by FISH using the Vysis CLL probe kit.
- •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 (approximately 80% or more), G-CSF may be administered after Screening and prior to the first dose of ABT-199 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 with the approval of the Abbott medical monitor).
- •5. For high risk subjects (as defined in Section 6.7.1) 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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Subject has undergone an allogeneic stem cell transplant or has developed Richter's transformation.
- •2. Subject has received a biologic agent (i.e. monoclonal antibodies) for anti-neoplastic intent within 8 weeks prior to the first dose of study drug. Subject has received any anti-cancer therapy including chemotherapy, or radiotherapy; Investigational therapy, including targeted small molecule agents within 14 days 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:
- •3. Subject has a significant history of renal, 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 discussion with the investigator and the AbbVie medical monitor must occur. 4. Exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal).
- •5. 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.
- •6. Subject has active and uncontrolled autoimmune cytopenias (for 2 weeks), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP).
- •7. Subject has tested positive for HIV due to potential drug-drug interactions as well as anticipated mechanism-based lymphopenia that may increase the risk of
- •opportunistic infections.
- •8. Cardiovascular disability status of New York Heart Association Class =2.
- •9.Subject has known allergy to both xanthine oxidase inhibitors and rasburicase.
研究者
相似试验
进行中（未招募）
1 期
A Study of the Efficacy of ABT-199 (GDC-0199) in Subjects withRelapsed/Refractory or previously untreated Chronic LymphocyticLeukemia with the 17p DeletioEUCTR2012-004027-20-PLAbbVie Deutschland GmbH & Co. KG150
进行中（未招募）
1 期
A Study of the Efficacy of ABT-199 (GDC-0199) in Subjects with Relapsed or Refractory or previously untreated Chronic Lymphocytic Leukemia with the 17p DeletioChronic Lymphocytic Leukemia 17 p DeletionMedDRA version: 20.0 Level: LLT Classification code 10024340 Term: Leukemia lymphocytic chronic System Organ Class: 100000004864EUCTR2012-004027-20-GBAbbVie Deutschland GmbH & Co. KG150
进行中（未招募）
1 期
A Study of the Efficacy of ABT-199 (GDC-0199) in Subjects with Relapsed / Refractory or previously untreated Chronic Lymphocytic Leukemia with the 17p DeletioEUCTR2012-004027-20-DEAbbVie Deutschland GmbH & Co. KG150
进行中（未招募）
1 期
Ph2 study of chemotherapy plus ABT-165 compared to chemotherapy plus bevacizumab in people with metastatic colorectal (bowel) cancermetastatic adenocarcinoma of the colon or rectum previously treated with a regimen containing fluoropyrimidine/oxaliplastin and bevacizumabEUCTR2017-003669-87-ESAbbvie Deutschland GmbH & Co. KG100
进行中（未招募）
1 期
Ph2 study of chemotherapy plus ABT-165 compared to chemotherapy plus bevacizumab in people with metastatic colorectal (bowel) cancermetastatic adenocarcinoma of the colon or rectum previously treated with a regimen containing fluoropyrimidine/oxaliplatin and bevacizumabEUCTR2017-003669-87-BEAbbvie Deutschland GmbH & Co. KG100