Clinical Trials in Italy / NCT04476199
Active, not recruiting
Phase 2
Venetoclax and Decitabine Assessment in Patients (≥60 - <75 Years) with Newly Diagnosed AML Eligible for Allo-SCT
NCT04476199 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Acute Myeloid Leukemia
Investigational drug(s) / intervention(s)
Venetoclax and Decitabine
Venetoclax and Decitabine: The prognosis of acute myeloid leukemia (AML) patients aged over 60 years is poor and allogeneic stem cell transplantation (allo-SCT) is the only curative option.The association VEN-DEC is a promising combination therapy for AML elderly patients who are fit and eligible for allo-SCT.
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Response to VEN-DEC chemo-free combination (ELN Guidelines) — At the end of cycle 2 (each cycle is 28 days)
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; - Allo-SCT — 18 months from 1st enrolled patient
Proportion of patients who undergo to allo-SCT in first CR/CRi/MLFS - Allo-SCT Engraftment — up to 24 weeks
Percentage of patients with Neutrophil engraftment and percentage of patients with platelet engraftment - Overall Survival (OS) — at 2 year post transplant
at 2 year post transplant. OS is defined as the time from transplant to the date of death due to any cause or to the last date the patient was known to be alive (censored observation) or to the date of the data cut-off for final analysis - Cumulative incidence of Non-Relapse Mortality — at 100 days
NRM is defined as death due to any other cause than progression of malignancy after allogeneic stem cell transplantation. Cumulative incidence will be estimated at 100 days - Cumulative incidence of Non-Relapse Mortality — at 180 days
NRM is defined as death due to any other cause than progression of malignancy after allogeneic stem cell transplantation. Cumulative incidence will be estimated at 180 days - Cumulative incidence of Non-Relapse Mortality — at 365 days
NRM is defined as death due to any other cause than progression of malignancy after allogeneic stem cell transplantation. Cumulative incidence will be estimated at 365 days
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| USD, Trapianti di Midollo osseo, Azienda Spedali Civili di Brescia | Brescia | Brescia | |
| Unità Terapia Intensiva Ematologica e terapia cellulari - casa della sofferenza | San Giovanni Rotondo | Foggia | |
| UO Ematologia e TMO - Ospedale C. Panico | Tricase | Lecce | |
| Ospedale San Gerardo | Monza | Monza | |
| Clinica di Ematologia. AOU Ospedali Riuniti di Ancona | Ancona | Italy | |
| UOC di Ematologia, Ospedale C e G Mazzoni | Ascoli Piceno | Italy | |
| U.O. Ematologia con Trapianto, Policlinico di Bari | Bari | Italy | |
| Ospedale Seragnoli Malpighi | Bologna | Italy | |
| Ospedale Policlinico di Catania, TMO | Catania | Italy | |
| Struttura Complessa di Ematologia, Azienda Ospedaliera Santa Croce e Carle | Cuneo | Italy | |
| Terapie Cellulari e Medicina Trasfusionale, Ospedale Careggi | Florence | Italy | |
| UO Ematologia, Programma Trapianti IRCCS Ospedale Policlinico San Martino, Genova | Genova | Italy | |
| Centro Trapianto Fondazione IRCCS Cà Granda - Osp. Maggiore | Milan | Italy | |
| Div. di Ematologia e TMO, Istituto Nazionale Tumori | Milan | Italy | |
| Div. di Ematologia, Talamona, Osp. Niguarda, Ca-Granda | Milan | Italy | |
| Istituto Clinico Humanitas, Oncologia ed Ematologia | Milan | Italy | |
| Unità Operativa di Ematologia e Trapianto Midollo Osseo (UTMO), Ospedale San Raffaele di Milano | Milan | Italy | |
| UOSC Ematologia con Trapianto CSE, AORN A. Cardarelli, AORN Cardarelli | Naples | Italy | |
| CTMO Osp. V. Cervello Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello | Palermo | Italy | |
| Dip.di Ematologia, Osp. Civile di Pescara, Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico | Pescara | Italy | |
| CTMO Centro Unico, Regionale Trapianti di Cellule Staminali e Terapie Cellulari, "A. Neri", Grande Osp. Bianchi, Melacrino Morelli | Reggio Calabria | Italy | |
| Policlinico Tor Vergata | Roma | Italy | |
| A.O.U. Citta della Salute e della Scienza | Torino | Italy | |
| UOC di Ematologia, Osp. dell'Angelo | Venezia | Italy | |
| Div. di Ematologia - Unità di TMO e Oncoematologia Pediatrica Policlinico GB Rossi | Verona | Italy |
More Gruppo Italiano Trapianto di Midollo Osseo trials in Italy
Pentaglobin in CRE and PA Neutropenic Infections
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04476199 on ClinicalTrials.gov ↗ ← All trials in Italy