VEN-DEC GITMO Study

Trial details

Who runs it

Gruppo Italiano Per Il Trapianto Di Midollo Osseo Cellule Staminali Emopoietiche E Terapia Cellulare

Trial code

EU 2024-518792-54-00

Record updated

2025. november 25.

Original description

The primary objective of the study is to evaluate the proportion of elderly (≥60 - <75 years) patients with newly diagnosed AML eligible for allo-SCT treated with the “chemo-free” combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR, CRi or MLFS.Read full original descriptionShow less

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)

The primary objective of the study is to evaluate the proportion of elderly (≥60 - <75 years) patients with newly diagnosed AML eligible for allo-SCT treated with the “chemo-free” combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR, CRi or MLFS.

Inclusion: Patients ≥ 60 <75 years of age • Diagnosis of AML eligible for allo-SCT from any donor • High- and Intermediate-Risk ELN • WBC <25x109/L (Hydroxyurea is permitted to meet this criterion) • Adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL) • Adequate renal function (creatinine clearance ≥50 ml/min) • ECOG Performance Status ≤ 2 • Males enrolled in the study with partners who are women of childbearing potential, must be willing to use an acceptable barrier contraceptive method during the trial. • Women of childbearing potential must use highly effective contraception for at least 1 month after the last dose of VEN and for however long the EU SmPC says for DEC • Willing and able to comply with all of the requirements and visits in the protocol. • Written and signed informed consent.

Exclusion: Previous treatment for AML (Hydroxyurea is allowed) or for an antecedent Myelodysplastic Syndrome (MDS) • Subject has known active CNS involvement with AML • Absence of informed consent • AML patients with t(15;17); t(8;21); inv(16) • Low Risk ELN grade > 2 NCI-CTCAE (v. 5) adverse events at the time of enrollment • Serious organ dysfunction: left ventricular ejection fraction < 40%, FEV1, FVC, DLCO (diffusion capacity) < 40% of predicted, LFT > 5 times the upper limit of normal, or creatinine clearance < 40 ml/min. • The evidence of HBV or HCV active infection (HBV DNA HCV RNA positive test). • Patients with HIV infection • Current uncontrolled infections • Patients with other life-threatening concurrent disease • Patients receiving strong CYP3A inducers (eg Carbamazepime, Phenytoin, Rifampicin), within seven days before the first dose of VEN-DEC combination. • Subjects with known hypersensitivity to any of the component medication • Subject has a history of other malignancies within 2 years prior to study entry, with the exception of: - Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; - Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; - Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. • Participation in another clinical trial within 1 month before the start of this trial.

EU CTIS 2024-518792-54-00