EUCTR2015-004936-36-FI进行中（未招募）1 期
A phase 3 multicenter, randomized, prospective, open-label trial ofstandard chemoimmunotherapy (FCR/BR) versus rituximab plus venetoclax(RVe) versus obinutuzumab (GA101) plus venetoclax (GVe)versus obinutuzumab plus ibrutinib plus venetoclax (GIVe) in fit pa-tientswith previously untreated chronic lymphocytic leukemia (CLL) withoutdel(17p) or TP53 mutation - CLL13
niversity of Cologne0 个研究点目标入组 920 人开始时间: 2016年12月8日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 920
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. Documented CLL requiring treatment according to iwCLL
- •criteria12.
- •2. Age at least 18 years.
- •3. Life expectancy = 6 months.
- •4. Ability and willingness to provide written informed consent and to
- •ad-here to the study visit schedule and other protocol requirements.
- •5. Adequate bone marrow function indicated by a platelet count >30
- •x10^9/l (unless directly attributable to CLL infiltration of the bone
- •marrow, proven by bone marrow biopsy)
- •6. Creatinine clearance =70ml/min directly measured with 24hr urine
- •collection or calculated according to the modified formula of Cockcroft
- •and Gault (for men: GFR ˜ ((140 - age) x bodyweight) / (72 x
- •creatinine), for women x 0, 85).
- •Dehydrated patients with an estimated creatinine clearance less than 70
- •ml/min may be eligible if a repeat estimate after adequate hydration is >
- •7. Adequate liver function as indicated by a total bilirubin= 2 x,
- •AST/ALT = 2.5 x the institutional ULN value, unless directly attributable
- •to the patient's CLL or to Gilbert's Syndrome.
- •8. Negative serological testing for hepatitis B (HBsAg negative and anti-
- •HBc negative; patients positive for anti-HBc may be included if PCR for
- •HBV DNA is negative and HBV-DNA PCR is performed every month until
- •12 months after last treatment cycle), negative testing for hepatitis C
- •RNA within 6 weeks prior to registration.
- •9. Eastern Cooperative Oncology Group Performance Status (ECOG)
- •performance status 0-2.
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 320
排除标准
- •1. Any prior CLL-specific therapies (except corticosteroid treatment administered
- •due to necessary immediate intervention; within the last 10
- •days before start of study treatment, only dose equivalents of 20 mg
- •prednisolone are permitted).
- •2. Transformation of CLL (Richter transformation).
- •3. Decompensated hemolysis, defined as ongoing hemoglobin drop in
- •spite of three more concurrent treatments being administered for hemolysis
- •4. Detected del(17p) or TP53 mutation.
- •5. Patients with a history of PML.
- •6. Any comorbidity or organ system impairment rated with a single
- •CIRS (cumulative illness rating scale) score of 4 (excluding the
- •eyes/ears/nose/throat/larynx organ system), a total CIRS score of
- •more than 6 or any other life-threatening illness, medical condition or
- •organ system dysfunction that, in the investigator´s opinion, could
- •comprise the patients safety or interfere with the absorption or metabolism
- •of the study drugs (e.g, inability to swallow tablets or im-paired
- •resorption in the gastrointestinal tract).
- •7. Urinary outflow obstruction.
- •8. Malignancies other than CLL currently requiring systemic therapies,
- •not being treated in curative intention before (unless the malignant
- •disease is in a stable remission due to the discretion of the treating
- •physician) or showing signs of progression after curative treatment.
- •9. Uncontrolled or active infection.
- •10. Patients with known infection with human immunodeficiency virus
- •11. Requirement of therapy with strong CYP3A4 and CYP3A5 inhibitors/
- •12. Anticoagulant therapy with warfarin or phenoprocoumon,
- •(rotation to alternative anticoagulation is allowed, but note that patients
- •being treated with NOAKs can be included, but must be properly
- •informed about the potential risk of bleeding under treatment with
- •ibrutinib).
- •13. History of stroke or intracranial hemorrhage within 6 months prior
- •to registration.
- •14. Use of investigational agents which might interfere with the study
- •drug within 28 days prior to registration.
- •15. Vaccination with live vaccines 28 days prior to registration.
- •16. Major surgery less than 30 days before start of treatment.
- •17. History of severe allergic or anaphylactic reactions to humanized or
- •murine monoclonal antibodies, known sensitivity or allergy to murine
- •18. Known hypersensitivity to any active substance or to any of the
- •excipients of one of the drugs used in the trial.
- •19. Pregnant women and nursing mothers (a negative pregnancy test is
- •required for all women of childbearing potential within 7 days before
- •start of treatment; further pregnancy testing will be performed
- •regularly).
- •20. Fertile men or women of childbearing potential unless:
- •a. surgically sterile or = 2 years after the onset of menopause
- •b. willing to use two methods of reliable contraception including one
- •highly effective contraceptive method (Pearl Index <1) and one
- •additional effective (barrier) method during study treatment and for 18
- •months after the end of study treatment.
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