AzTrials
AzTrials

Elderly AML PatientsPhase 3NCT06073730

Comparison of the Efficacy and Safety of Venetoclax in Combination With 3 Days Decitabine (DEC3-VEN) vs. Venetoclax in Combination With Azacitidine (VIALE-A) in the Treatment of Elderly Patients or Unfit, New-diagnosis Acute Myeloid Leukemia Patients

A Phase 3 study testing Experimental: Venetoclax in combination with Decitabine (+-sorafenib) and Active Comparator: Standard dose of Venetoclax + Azacitidine in people with Elderly AML Patients and Unfit, New-diagnosis AML, run by The Second Affiliated Hospital of Kunming Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Combining the results of previous studies and based on the clinical practice in our center, we designed the Venetoclax in combination with 3days-Decitabine regimen for induction therapy in elderly or unfit AML patients with a primary diagnosis, and set Venetoclax in combination with Azacitidine (VIALE-A) as a control… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Experimental: Venetoclax in combination with Decitabine (+-sorafenib) and Active Comparator: Standard dose of Venetoclax + Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteChina
Study dates
1 Nov 2023to 30 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects suitable for enrollment in this study must meet all of the following criteria.
  • meet the World Health Organization diagnostic criteria (WHO2022 criteria) except APL or carry one of the abnormal karyotypes such as t(8;21)/(RUNX1::RUNX1TI), inv(16)(p13.1q22), t(16;16) (p13.1q22), t(16;16)/CBFβ::myh11), etc. Patients with acute myeloid leukemia other than those with one of the abnormal karyotypes such as t(16;16)/CBFβ::myh11
  • Patients with AML not otherwise classified under the World Health Organization AML classification, except for acute myeloproliferative disorder with myelofibrosis and myeloid sarcoma.
  • Male or female, A: Elderly patients aged > or = 60 years (unwilling to undergo intense chemotherapy); B: Patients aged > 18 years who are not candidates for standard-dose chemotherapy, defined as those with at least one of the following comorbidities: 1) Eastern Collaborative Oncology Group Physical Conditioning Grading (ECOG) score of 2 or 3; 2) Chronic heart failure (CHF) requiring treatment or with a left ventricular ejection fraction (LVEF) of ≤ 50%; 3) Chronic heart failure (CHF) requiring treatment or with a left ventricular ejection fraction (LVEF) of ≤ 50%. heart failure (CHF) cardiac history or chronic unstable angina; 3) carbon monoxide diffusing capacity (DLCO) ≤65% or forced expiratory volume in 1 second (FEV1) ≤65%; 4) creatinine clearance of ≥30 mL/min to ≤45 mL/min; and 5) any other condition deemed by the investigator to be incompatible with standard-dose chemotherapy must be reviewed with the study chair prior to study enrollment ;
  • patients have not received prior treatment for AML (except hydroxyurea and Ara-C <1.0 g/d).
  • Eastern Cooperative Oncology Group Physical Status Assessment (ECOG-PS) score of <=3.
Show all 12Show fewer
  • pass the requirements for the following laboratory test indices (performed within 7 days prior to treatment):
  • <!-- -->
  • Aspartate aminotransferase (ALT), alanine aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN), serum bilirubin ≤ 2 x ULN; and serum cardiac enzymes < 2.0 x ULN; unless considered to be leukemic organ involvement.
  • Creatinine ≥ 30 mL/min, calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.
  • 7.Subjects of childbearing potential must have a negative pregnancy test result within 72 hours prior to the start of treatment, and participating patients must use contraception during trial treatment and for 3 years after completion of treatment.
  • 8. life expectancy greater than 2 months. 9. Informed consent must be signed prior to the start of all specific study procedures, either by the patient himself/herself or by a member of his/her immediate family; in view of the patient's condition, if the patient's own signature would not be conducive to the treatment of his/her condition, the informed consent will be signed by the legal guardian or by a member of the patient's immediate family.

Who cannot join

  • Subjects may not be enrolled in this study if they meet any of the following criteria:
  • AML with BCR-ABL1; or CML bone marrow acute stage.
  • Treatment-naïve patients (is defined as having received induction chemotherapy in the past, regardless of efficacy).
  • Secondary leukemia (mainly refers to those whose World Health Organization (WHO) AML classification belongs to the subcategory of treatment-related AML and those with a history of prior MDS and/or MPD).
  • concomitant other hematologic diseases (such as hemophilia, myelofibrosis and other investigators considered unsuitable for enrollment; previous blood abnormalities, but ever bone marrow examination except MDS and MPD allowed enrollment).
  • 5、Pregnant or lactating patients. 6, Allergic to any of the drugs involved in this study. 7, Have used strong or moderate CYP7A inducers within 3 days before the start of study treatment.
Show all 14Show fewer
  • 8, Concomitant malignant tumors of other organs (those requiring treatment). 9, Significantly abnormal hepatic or renal function beyond the enrollment criteria.
  • 10, Active heart disease, defined as one or more of the following:
  • Myocardial infarction less than 6 months from study entry;
  • A history of arrhythmia requiring drug therapy or severe clinical symptoms;
  • Uncontrolled or symptomatic congestive heart failure (> NYHA class 2); 10, patients with severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis), known infection with human immunodeficiency virus (HIV) or active hepatitis B or C.
  • 11. Subjects with evidence of central nervous system leukemia prior to treatment.
  • Subjects with epilepsy, dementia, or other abnormal mental states that require medication and who are unable to understand or follow the regimen.
  • 13, Conditions that limit oral drug intake or gastrointestinal absorption. 14, Subjects who, in the opinion of the investigator, are not suitable for enrollment

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Kunming Medical University.

    Kunming, Yunnan

Other trials in China

About this study

Official title: Department of Hematology, The Second Affiliated Hospital of Kunming Medical University.

Combining the results of previous studies and based on the clinical practice in our center, we designed the Venetoclax in combination with 3days-Decitabine regimen for induction therapy in elderly or unfit AML patients with a primary diagnosis, and set Venetoclax in combination with Azacitidine (VIALE-A) as a control group to compare the efficacy and safety and to provide evidence for the optimal selection of the clinical treatment regimen.

PRIMARY ENDPOINT: To assess whether Venetoclax in combination with 3 days-diascitabine versus standard dose Venetoclax in combination with azacitidine improves event-free survival (EFS) in elderly or adult patients with unfit AML during the maximum follow-up period. Event-free survival was defined as the absence of events such as treatment failure, intolerance withdrawal, all-cause death, or achievement of CR or CRi, or relapse after MLFS, whichever occurred first, between patients' randomization and the maximum follow-up period. Treatment failure was defined as failure to achieve CR or CRi, MLFS after 2 courses of induction therapy.

Read the detailed description

Induction therapy regimen:

A: Experimental group: Venetoclax in combination with Decitabine (+-sorafenib) Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-14 Decitabine (DEC) 20mg/m2/q8h, d4-6 (infusion time >2h) Sorafenib 600mg/d, d8-14 (FLT3/ITD mutation positive patients) B: Control: standard dose of Venetoclax + Azacitidine Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-28 Azacitidine (AZA) 75mg/m2/d, d3-9

Post-remission treatment regimen:

A: Experimental group: Venetoclax combined with Decitabine Venetoclax (VEN ) 400mg/d, d1-7 Decitabine (DEC) 20mg/m2/q8h, d2-3 (this regimen is repeated every 4-6 weeks) B: Control Group: Venetoclax combined with Azacitidine Venetoclax (VEN ) 100mg d1, 200mg d2, 400mg/d d3-28 Azacitidine (AZA) 75mg/m2/d, d3-9 (this regimen is repeated every 4-6 weeks)

Being tested
Experimental: Venetoclax in combination with Decitabine (+-sorafenib), Active Comparator: Standard dose of Venetoclax + Azacitidine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Venetoclax in combination with Decitabine (+-sorafenib)Procedure or surgery

    Also called DEC3-VEN

    Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-14 Decitabine (DEC) 20mg/m2/q8h, d4-6 (infusion time >2h) Sorafenib 600mg/d, d8-14 (FLT3/ITD mutation positive patients)

  • Active Comparator: Standard dose of Venetoclax + AzacitidineProcedure or surgery

    Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-28 Azacitidine (AZA) 75mg/m2/d, d3-9

Study groups in NCT06073730
Study groupRoleWhat they receive
Venetoclax in combination with Decitabine (+-sorafenib)ExperimentalVenetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-14 Decitabine (DEC) 20mg/m2/q8h, d4-6 (infusion time >2h) Sorafenib 600mg/d, d8-14 (FLT3/ITD mutation positive patients)
Receives: Procedure: Experimental: Venetoclax in combination with Decitabine (+-sorafenib)
Standard dose of Venetoclax + AzacitidineActive comparatorVenetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-28 Azacitidine (AZA) 75mg/m2/d, d3-9
Receives: Procedure: Active Comparator: Standard dose of Venetoclax + Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival

    Event-free survival was defined as the absence of events such as treatment failure, intolerance withdrawal, all-cause death, or relapse after achieving CR or CRi, MLFS, whichever occurred first, between patients' randomization and the maximum follow-up period. Treatment failure was defined as failure to achieve CR or CRi, MLFS after 2 courses of induction therapy.

    Measured: up to 12 months

Secondary outcomes (3)

  1. overall survival rate

    Survival of patients from initiation of treatment to maximum follow-up period

    Measured: up to 12 months

  2. CR/CRi rate

    CR/CRi rate from initiation of treatment to maximum follow-up period

    Measured: up to 12 months

  3. First course CR/CRi rate

    CR/CRi rate in patients after receiving the first course of induction therapy

    Measured: up to 1 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start1 Nov 2023
  3. Primary completion30 Dec 2025
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06073730
Sponsor's protocol ID
SHEN-PJ-KE-2023-223
Status last verified
Sep 2026
First submitted
3 Oct 2023
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Almeida AM, Prebet T, Itzykson R, Ramos F, Al-Ali H, Shammo J, Pinto R, Maurillo L, Wetzel J, Musto P, Van De Loosdrecht AA, Costa MJ, Esteves S, Burgstaller S, Stauder R, Autzinger EM, Lang A, Krippl P, Geissler D, Falantes JF, Pedro C, Bargay J, Deben G, Garrido A, Bonanad S, Diez-Campelo M, Thepot S, Ades L, Sperr WR, Valent P, Fenaux P, Sekeres MA, Greil R, Pleyer L. Clinical Outcomes of 217 Patients with Acute Erythroleukemia According to Treatment Type and Line: A Retrospective Multinational Study. Int J Mol Sci. 2017 Apr 14;18(4):837. doi: 10.3390/ijms18040837.

    PubMed 28420120

  • Krug U, Buchner T, Berdel WE, Muller-Tidow C. The treatment of elderly patients with acute myeloid leukemia. Dtsch Arztebl Int. 2011 Dec;108(51-52):863-70. doi: 10.3238/arztebl.2011.0863. Epub 2011 Dec 26.

    PubMed 22259641

  • Pettit K, Odenike O. Defining and Treating Older Adults with Acute Myeloid Leukemia Who Are Ineligible for Intensive Therapies. Front Oncol. 2015 Dec 14;5:280. doi: 10.3389/fonc.2015.00280. eCollection 2015.

    PubMed 26697412

  • Kantarjian H, Ravandi F, O'Brien S, Cortes J, Faderl S, Garcia-Manero G, Jabbour E, Wierda W, Kadia T, Pierce S, Shan J, Keating M, Freireich EJ. Intensive chemotherapy does not benefit most older patients (age 70 years or older) with acute myeloid leukemia. Blood. 2010 Nov 25;116(22):4422-9. doi: 10.1182/blood-2010-03-276485. Epub 2010 Jul 28.

    PubMed 20668231

  • Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Bernal del Castillo T, Al-Ali HK, Martinelli G, Falantes J, Noppeney R, Stone RM, Minden MD, McIntyre H, Songer S, Lucy LM, Beach CL, Dohner H. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18.

    PubMed 25987659

  • Kantarjian HM, Thomas XG, Dmoszynska A, Wierzbowska A, Mazur G, Mayer J, Gau JP, Chou WC, Buckstein R, Cermak J, Kuo CY, Oriol A, Ravandi F, Faderl S, Delaunay J, Lysak D, Minden M, Arthur C. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol. 2012 Jul 20;30(21):2670-7. doi: 10.1200/JCO.2011.38.9429. Epub 2012 Jun 11.

    PubMed 22689805

  • Del Poeta G, Venditti A, Del Principe MI, Maurillo L, Buccisano F, Tamburini A, Cox MC, Franchi A, Bruno A, Mazzone C, Panetta P, Suppo G, Masi M, Amadori S. Amount of spontaneous apoptosis detected by Bax/Bcl-2 ratio predicts outcome in acute myeloid leukemia (AML). Blood. 2003 Mar 15;101(6):2125-31. doi: 10.1182/blood-2002-06-1714. Epub 2002 Nov 7.

    PubMed 12424199

  • Mei M, Aldoss I, Marcucci G, Pullarkat V. Hypomethylating agents in combination with venetoclax for acute myeloid leukemia: Update on clinical trial data and practical considerations for use. Am J Hematol. 2019 Mar;94(3):358-362. doi: 10.1002/ajh.25369. Epub 2018 Dec 13.

    PubMed 30499168

  • DiNardo CD, Pratz K, Pullarkat V, Jonas BA, Arellano M, Becker PS, Frankfurt O, Konopleva M, Wei AH, Kantarjian HM, Xu T, Hong WJ, Chyla B, Potluri J, Pollyea DA, Letai A. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019 Jan 3;133(1):7-17. doi: 10.1182/blood-2018-08-868752. Epub 2018 Oct 25.

    PubMed 30361262

  • DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Dohner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hajek R, Porkka K, Illes A, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.

    PubMed 32786187

  • DiNardo CD, Maiti A, Rausch CR, Pemmaraju N, Naqvi K, Daver NG, Kadia TM, Borthakur G, Ohanian M, Alvarado Y, Issa GC, Montalban-Bravo G, Short NJ, Yilmaz M, Bose P, Jabbour EJ, Takahashi K, Burger JA, Garcia-Manero G, Jain N, Kornblau SM, Thompson PA, Estrov Z, Masarova L, Sasaki K, Verstovsek S, Ferrajoli A, Weirda WG, Wang SA, Konoplev S, Chen Z, Pierce SA, Ning J, Qiao W, Ravandi F, Andreeff M, Welch JS, Kantarjian HM, Konopleva MY. 10-day decitabine with venetoclax for newly diagnosed intensive chemotherapy ineligible, and relapsed or refractory acute myeloid leukaemia: a single-centre, phase 2 trial. Lancet Haematol. 2020 Oct;7(10):e724-e736. doi: 10.1016/S2352-3026(20)30210-6. Epub 2020 Sep 5.

    PubMed 32896301

  • DiNardo CD, Lachowiez CA, Takahashi K, Loghavi S, Xiao L, Kadia T, Daver N, Adeoti M, Short NJ, Sasaki K, Wang S, Borthakur G, Issa G, Maiti A, Alvarado Y, Pemmaraju N, Montalban Bravo G, Masarova L, Yilmaz M, Jain N, Andreeff M, Jabbour E, Garcia-Manero G, Kornblau S, Ravandi F, Konopleva MY, Kantarjian HM. Venetoclax Combined With FLAG-IDA Induction and Consolidation in Newly Diagnosed and Relapsed or Refractory Acute Myeloid Leukemia. J Clin Oncol. 2021 Sep 1;39(25):2768-2778. doi: 10.1200/JCO.20.03736. Epub 2021 May 27.

    PubMed 34043428

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Experimental: Venetoclax in combination with Decitabine (+-sorafenib) and Active Comparator: Standard dose of Venetoclax + Azacitidine in people with Elderly AML Patients and Unfit, New-diagnosis AML, run by The Second Affiliated Hospital of Kunming Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06073730, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in