EUCTR2020-003061-19-HU进行中（未招募）1 期
Phase I / II, open label, dose escalation part (phase I) followed by non-comparative expansion part (phase II), multi-centre study, evaluating safety, pharmacokinetics and efficacy of S65487, a Bcl2 inhibitor combined with azacitidine in adult patients with previously untreated acute myeloid leukemia not eligible for intensive treatment
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 109
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 participant aged = 18 years
- •2. Participants with cytologically confirmed and documented treatment naïve, de novo or secondary AML defined by WHO 2016 classification (Arber, 2016). Secondary AML includes:
- •a. Previous myelodysplastic syndrome transformed
- •b. AML due to exposure to potentially leukemogenic therapies or agents (e.g. radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 3 years
- •3. Participants not eligible for standard induction chemotherapy
- •a. Aged = 75 years old
- •b. Or Age =18 years with at least one of the following comorbidities:
- •i. Clinically significant heart or lung comorbidities, as reflected by at least one of:
- •- Lung diffusing capacity for carbon monoxide (DLCO) =65% of expected
- •- Forced expiratory volume in 1 second (FEV1) =65% of expected
- •ii. Other contraindication(s) to anthracycline therapy (must be documented)
- •iii. Other comorbidity that the Investigator judges as incompatible with intensive remission induction chemotherapy, which must be documented
- •4. ECOG (Eastern Cooperative Oncology Group) performance status should be (criterion should be rechecked at inclusion visit) ECOG = 2.
- •5. Written informed consent obtained prior any study-specific procedure as described in section 13.3 of the protocol.
- •6. Adequate renal and hepatic function
- •7. Circulating White Blood Cell Count (WBC count) < 25*109 G/L (with or without use of hydroxycarbamide/leukapheresis
- •8. Serum potassium, serum calcium, serum phosphates, serum magnesium within normal limits with or without supplementation.
- •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 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •8. Major surgery within 3 weeks prior to the first IMP administration, or participants who have not recovered from side effects of the surgery
- •9. Any radiotherapy within 3 weeks before the first IMP administration, (except for palliative radiotherapy at localised lesions not considered as target lesions)
- •10. Allogenic stem cell transplant within 3 months before the first IMP administration and/or participants with active Graft-versus-host disease within 3 months before the first IMP administration and/or participants who still receive immunosuppressive treatment within 3 months before the first IMP administration and/or participant who receive donor lymphocyte infusion (DLI) within 3 months before the first IMP administration
- •11. Acute promyelocytic leukemia (APL, French-American-British M3 classification)
- •12. Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per the National Comprehensive Cancer Network (NCCN) Guidelines Version 3, 2019 for Acute Myeloid Leukemia
- •13. Treatment with hypomethylating agents (decitabine/azacitidine) or Bcl-2 inhibitor,particularly venetoclax for AHD (antecedent hematologic disorders)
研究者
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