EUCTR2014-000580-40-DE进行中（未招募）1 期
A prospective, open-label, multicentre phase-II-trial to evaluate the efficacy and safety of a sequential regimen of Bendamustine followed by GA101 (Obinutuzumab) and ABT-199 (Venetoclax) followed by ABT-199 and GA101 maintenance in CLL patients - CLL2-BAG
niversity of Cologne0 个研究点目标入组 62 人开始时间: 2015年1月22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
- 62
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 (irrespective if first or relapse treatment) according to iwCLL criteria
- •In case of previously treated patients, these must have recovered from acute toxicities and treatment regimen must be stopped within the following time periods before start of study treatment in the CLL2-BAG trial:
- •chemotherapy within = 28 days
- •antibody treatment within = 14 days
- •kinase inhibitors, BCL2-antagonists or immunmodulatory agents within = 3 days
- •corticosteroids may be applied until the start of the BAG-regimen, these have to be reduced to an equivalent of = 20mg prednisolone during treatment
- •2. Adequate renal function, as indicated by a creatinine clearance =30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24 hr. urine collection
- •3. Adequate hematologic function as indicated by a platelet count = 25 x 10 9/L, a neutrophil count = 1,0 x 10 9/L and a hemoglobin value = 8.0 g/dL, unless directly attributable to the patient´s CLL (e.g. bone marrow infiltration)
- •4. Adequate liver function as indicated by a total bilirubin =2x, AST/ALT =2.5x the institutional ULN value, unless directly attributable to the patient’s CLL or to Gilbert’s Syndrome
- •5. Negative serological testing for hepatitis B (HBsAg nega-tive 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 1 year after last dosage of obinutuzumab), negative testing for hepatitis-C RNA and negative HIV test within 6 weeks prior to registration
- •6. Age = 18 years
- •7. ECOG 0 to 2, ECOG 3 is only permitted if related to CLL (e.g. due to anemia or severe constitutional symptoms)
- •8. Life expectancy = 6 months
- •9. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
- •Inclusion criteria for extended follow-up and re-treatment (Amendment 4 and 5):
- •1.Patients must have participated in the CLL2-BAG trial and must have benefitted from study treatment (clinical re-lapse =6 months after discontinuation of treatment due to a MRD negative response or, completion of 24-months of maintenance treatment or toxicity)
- •2.Only patients with a confirmed progression of CLL who are in need of treatment according to iwCLL 2008 criteria4 are eligible for retreatment with venetoclax and obinutuzumab
- •Please note: Patients with a MRD conversion from nega-tive/intermediate to positive without clinical signs of pro-gression should not (yet) receive a retreatment in the trial
- •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 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •1. Transformation of CLL (i.e. Richter’s transformation, pro-lymphocytic leukemia)
- •2. Known central nervous system (CNS) involvement
- •3. Patients with confirmed PML
- •4. Malignancies other than CLL currently requiring systemic therapies
- •5. Uncontrolled infection requiring systemic treatment
- •6. Any comorbidity or organ system impairment rated with a CIRS (cumulative illness rating scale) score of 4, excluding the eyes/ears/nose/throat/larynx organ system or any other life-threatening illness, medical condition or organ system dysfunction that – in the investigator´s opinion - could compromise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g, inability to swallow tablets or impaired resorption in the gastro-intestinal tract)
- •7. Requirement of therapy with strong CYP3A4 inhibitors/inducers or anticoagulant with warfarin, phenprocoumon (marcumar) or other vitamin K-antagonists
- •8. Use of investigational agents which would interfere with the study drug within 28 days prior to registration
- •9. Known hypersensitivity to obinutuzumab, venetoclax or any of the excipients
- •Please note: Patients with a known hypersensitivity to bendamustine are allowed to participate but will not receive a debulking with bendamustine
- •10. Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment, on day one of every debulking and induction cycle (monthly) and on day one of every maintenance cycle (every three months))
- •11. Fertile men or women of childbearing potential unless:
- •- surgically sterile or = 2 years after the onset of menopause, or
- •- willing to use two methods of reliable contraception including one highly effective (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 18 months after end of study treatment.
- •12. Vaccination with a live vaccine = 28 days prior to registration
- •13. Legal incapacity
- •14. Prisoners or subjects who are institutionalized by regulatory or court order
- •15. Persons who are in dependence to the sponsor or an investigator
- •Exclusion criteria for extended follow-up and re-treatment (Amendment 4 and 5):
- •3.Patients who received any subsequent treatment for CLL outside the study are ineligible
研究者
相似试验
进行中（未招募）
1 期
A prospective, open-label, multicentre phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by ofatumumab and ibrutinib followed by ibrutinib and ofatumumab maintenance in CLL patients (CLL2-BIO-trial of the GCLLSG)Fit and unfit patients with previously untreated or relapsed/refractory CLL requiring treatmentMedDRA version: 20.0Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-000590-39-DEniversity of Cologne62
进行中（未招募）
1 期
A prospective, open-label, multicentre phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by GA101 and ibrutinib (BIG) followed by ibrutinib and GA101 maintenance in CLL patients (CLL2-BIG protocol)Fit and unfit patients with previously untreated or relapsed/refractory CLL requiring treatmentMedDRA version: 19.1 Level: PT Classification code 10008958 Term: Chronic lymphocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-000569-35-DEniversity of Cologne62
进行中（未招募）
1 期
A prospective, open-label, multicenter phase-II-trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by GA101 (obinutuzumab) and CAL-101 (idelalisib) followed by CAL-101 and GA101 maintenance in CLL patients (CLL2-BCG-trial of the GCLLSG)EUCTR2014-000582-47-DEniversity of Cologne62
进行中（未招募）
1 期
Evaluation of a treatment with bendamustine, followed by obinutuzumab, zanubrutinib and venetoclax in patients with relapsed chronic lymphocytic leukemiaCTIS2022-502201-16-00niversity Of Cologne42
进行中（未招募）
1 期
Evaluation of a treatment with bendamustine, followed by obinutuzumab, acalabrutinib and venetoclax in patients with relapsed chronic lymphocytic leukemiaPatients with relapsed/refractory CLL requiring treatmentMedDRA version: 21.1Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-003133-28-DEniversität zu Köln46