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)
- Conditions
- allogeneic transplantation in CR / Cri / MLFS conditionMedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-002297-26-IT
- Lead Sponsor
- GITMO GRUPPO ITALIANO PER IL TRAPIANTO DI MIDOLLO OSSEO, CELLULE STAMINALI EMOPOIETICHE E TERAPIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method