Phase II study on Venetoclax (VEN) plus Decitabine (DEC) (VEN-DEC) for elderly (=60 <75years) patients with newly diagnosed Acute Myeloid Leukemia (AML) elegible for allogeneic Stem Cell Transplantation (allo-SCT) - VEN-DEC GITMO Study

GITMO GRUPPO ITALIANO PER IL TRAPIANTO DI MIDOLLO OSSEO, CELLULE STAMINALI EMOPOIETICHE E TERAPIA0 个研究点目标入组 100 人开始时间: 2021年1月25日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•Age> 60 - <75 years old
•Diagnosis of AMS eligible for allogeneic hematopoietic stem cell transplantation from any donor High and intermediate ELN risk
•WBC <25x10 ^ 9 / L (hydroxyurea is allowed to meet this criterion)
•Adequate liver function (bilirubin =2 UNL; ALT / AST =2.5 UNL)
•Adequate renal function (creatinine clearance =50 ml / min)
•Status Performance status: ECOG <2
•Men enrolled in the study with partners who are potentially fertile women must be willing to use an acceptable barrier method of contraception during the study.
•Women of childbearing potential must use a highly effective contraceptive method for at least one month after the last dose of Venetoclax and for the time indicated in the EU SmPC for Decitabine
•Availability and compliance with the requirements of the protocol
•Signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•Previous therapy for LAM (except hydroxyurea, which is allowed) or for myelodysplatic syndrome
•Presence of CNS localization
•Absence of informed consent
•Patients with AML t (15; 17); t (8; 21); inv (16) Low ELN risk
•Adverse events of grade> 2 NCI-CTCAE (v. 5) at the time of enrollment
•Important organ dysfunctions: ejection fraction of the left ventricle <40%, FEV1, FVC, DLCO <40% of predicted, LFT> 5 times higher than the normal limit, or creatinine clearance <40ml / min.
•Evidence of active HBV or HCV infection (positive test for HBV DNA HCV RNA)
•Patients with HIV infection
•Active uncontrolled infections
•Patients with other potentially life-threatening concomitant diseases
•Subjects with known hypersensitivity to any of the medicinal components
•Diagnosis of cancer in the 2 years preceding participation in the study, with the exception of:
•- In situ carcinoma of the uterine cervix or breast adequately treated;
•- Basal cell carcinoma of the skin or localized squamous skin carcinoma;
•- Previous neoplasm localized and surgically resected (or treated in other ways)
•Participation in another clinical trial within 1 month before the start of this trial

发起方

GITMO GRUPPO ITALIANO PER IL TRAPIANTO DI MIDOLLO OSSEO, CELLULE STAMINALI EMOPOIETICHE E TERAPIA