Clinical trial · Interventional
Venetoclax and Decitabine Assessment in Patients (≥60 - <75 Years) with Newly Diagnosed AML Eligible for Allo-SCT
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is a no profit, prospective, phase II, multicentre, non-randomised, uncontrolled, single group assignment, open label study to evaluate the safety and efficacy of the "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC) as "bridge" to allo-SCT in elderly (≥ 60 - \< 75 years) AML patients. The primary objective 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/MLFS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venetoclax and Decitabine | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment with VEN-DEC
- description
- Venetoclax will be given with a 3-day ramp up beginning with 100 mg dose on Day 1, with 200mg on Day 2, to reach the final dose of 400 mg on Day 3 of Cycle 1. Venetoclax will be continued at 400 mg daily. Tumor lysis prophylaxis will be administered from day -4, cycle 1 (oral uric acid reducing agent and hydration with at least 1.5 L/day).Decitabine will be administered at the dose of 20 mg/sqm intravenously from day 1 to day 5 every 28 days (VEN-DEC) for 2 cycles.
- interventionNames
- Combination Product: Venetoclax and Decitabine
Primary outcomes (7)
- measure
- Response to VEN-DEC chemo-free combination (ELN Guidelines)
- timeFrame
- At the end of cycle 2 (each cycle is 28 days)
- description
- response to VEN-DEC induction will be assessed on bone marrow according to the ELN Guidelines (13), as following: - CR without minimal residual disease (CR-MRD neg); (Complete Remission ) bone marrow blasts 5%) - CR remission with incomplete hematologic recovery (CRi): Morphologic Leukemia-free State (MLFS) Partial Remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%; - Primary refractory disease/Non response (NR): No CR or CRi after 2 courses of VEN-DEC; excluding patients with death in aplasia or death due to indeterminate cause;
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * • 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 Criteria: * • Previous treatment for AML (Hydroxyurea is allowed) or for an antecedent Myelodysplastic Syndrome (MDS). * Absence of informed consent * AML patients with t(15;17); t(8;21); inv(16) * Subject has known active CNS involvement with AML. * 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 * 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
References
Publications (1)
- DERIVEDRusso D, Polverelli N, Bernardi S, Santarone S, Farina M, Borlenghi E, Onida F, Castagna L, Bramanti S, Carella AM, Sorasio R, Martino M, Alati C, Olivieri A, Beltrami G, Curti A, Vetro C, Leotta S, Mancini V, Terruzzi E, Bernardi M, Galieni P, Musto P, Cerretti R, Giaccone L, Skert C, Radici V, Vezzoli M, Calza S, Leoni A, Garuffo L, Bonvicini C, Pellizzeri S, Malagola M, Ciceri F. Venetoclax plus decitabine as a bridge to allogeneic haematopoietic stem-cell transplantation in older patients with acute myeloid leukaemia (VEN-DEC GITMO): final report of a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2024 Nov;11(11):e830-e838. doi: 10.1016/S2352-3026(24)00241-2. Epub 2024 Sep 20. PMID 39312920