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 - CL1-65487-003

Institut De Recherches Internationales Servier IRIS0 个研究点目标入组 52 人开始时间: 2024年4月30日最近更新: 2024年7月22日

适应症

试验速览

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•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)

•Major surgery within 3 weeks prior to the first IMP administration, or participants who have not recovered from side effects of the surgery, Any radiotherapy within 3 weeks before the first IMP administration, (except for palliative radiotherapy at localised lesions not considered as target lesions), 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, Acute promyelocytic leukemia (APL, French-American-British M3 classification), 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, Previous treatment with hypomethylating agents (decitabine/azacitidine) or Bcl-2 inhibitors, particularly venetoclax for AHD (antecedent hematologic disorders)

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