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VEN-DEC GITMO Study
EU CTIS ID: 2024-518792-54-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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.
You likely can't join if
- • 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.