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AML, AdultPhase 3NCT05177731

Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML

A Phase 3 study testing Venetoclax, Decitabine for Injection and Cytarabine in people with AML, Adult and Chemotherapy Effect, run by Chen Suning at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This research is being done to assess the therapeutic efficacy and safety of a promising (venetoclax and decitabine) versus conventional "7+3"chemotherapy in induction young patients with acute myeloid leukemia. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
AML, Adult, Chemotherapy Effect
What is being tested?
Venetoclax, Decitabine for Injection and Cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteChina
Study dates
1 Mar 2022to 31 Dec 2024
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 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female, 59 > =Age (years) >= 18;
  • Newly diagnosed as AML patients according to World Health Organization (WHO) 2016 classification;
  • Patients have not received prior therapy for AML (except hydroxyurea and Ara-C<1.0g/d);
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
  • Liver function: Total bilirubin ≦3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN(except extramedullary infiltration of leukemia)
  • Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min;
  • Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.

Who cannot join

  • Acute promyeloid leukemia；
  • AML with central nervous system (CNS) infiltration；
  • Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
  • HIV infection;
  • Patients with severe heart failure (grade 3-4) ;
  • Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Uncontrolled and/or active systemic infection (viral, bacterial or fungal); b) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. c) An active second cancer that requires treatment within 6 months of study entry
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  • Patients deemed unsuitable for enrolment by the investigator;
  • Patients willing to receive intensive induction chemotherapy
  • Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen；
  • Patients reject to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: Comparing the Efficacy and Safety of Venetoclax Combined With Decitabine Versus Conventional "7+3" Induction Chemotherapy of Acute Myeloid Leukemia in Young Adults

This research is being done to assess the therapeutic efficacy and safety of a promising (venetoclax and decitabine) versus conventional "7+3"chemotherapy in induction young patients with acute myeloid leukemia.

This study involves the following:

Venetoclax and decitabine (investigational combination) Cytarabine and idarubicin (per standard of care)

Read the detailed description

This is an open-label, multicenter, phase 2 randomized clinical trial to compare the therapeutic efficacy and safety of venetoclax and decitabine to the conventional induction chemotherapy (7+3 regimen) among fit, young adults with newly diagnosed acute myeloid leukemia (AML).

Conventional induction chemotherapy with idarubicin and cytarabine is the standard of induction chemotherapy for acute myeloid leukemia (AML).

The FDA has approved the combination therapy of venetoclax and decitabine for elderly (> 60 year old) patients with newly diagnosed AML not eligible for intensive chemotherapy. Venetoclax is an inhibitor of BCL-2 (B-cell lymphoma 2, a protein that initiates tumor growth, disease progression, and drug resistance), which can lead to cancer cell death. Decitabine, a demethylation agent, has the potential to synergically target leukemia stem cell populations when combined with venetoclax as its homologous drug azacytidine.

Participants will be randomly assigned to one of the different induction groups and followed with either consolidation chemotherapy or allogeneic hematopoietic stem cell transplantation after remission. After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years.

It is expected that about 188 people will take part in this research study.

Being tested
Venetoclax, Decitabine for Injection, Cytarabine, Idarubicin, Gilteritinib
Keywords
Venetoclax, AML, young, induction therapy
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.

  • VenetoclaxDrug

    Also called Venclexta

    Orally by mouth

  • Decitabine for InjectionDrug

    Intravenous infusion

  • CytarabineDrug

    Also called Ara-C

    Intravenous infusion

  • IdarubicinDrug

    Also called IDA

    Intravenous infusion

  • GilteritinibDrug

    Also called XOSPATA

    Orally by mouth

Study groups in NCT05177731
Study groupRoleWhat they receive
Investigational ( venetoclax, decitabine)ExperimentalRandomized participants will receive induction as decitabine on days 1-5 and venetoclax daily on days 1-28. Second Induction (if not reach complete remission, but the percentage of blaste cells in bone marrow decreased by more than 50%):Re-induction with pre-induction therapy. Consolidation: If patients with favorable risk and MRD (Minimal Residual Disease) negative or refuse to allo-HSCT (Hematopoietic stem-cell transplantation), intermediate-dose (2g/m2 q12h days 1-3) for 4 cycles. If patients with intermediate or poor risk or favorable risk but MRD positive, intermediate-dose cytarabine for 1-2 cycles and follow up with allo-HSCT. For patients with FLT3 mutation, gilteritinib can be combined with the follow-up treatment after the end of initial induction.
Receives: Drug: Venetoclax; Drug: Decitabine for Injection; Drug: Gilteritinib
Standard of Care (Conventional Induction "7+3")ExperimentalRandomized participants will receive cytarabine and idarubicin per standard of care as follows: Induction: cytarabine on days 1-7 and idarubicin (12mg/m2) on days 1-3 . Second Induction (if not reach complete remission, but the percentage of blaste cells in bone marrow decreased by more than 50%): Re-induction with pre-induction therapy. Consolidation: If patients with favorable risk and MRD negative or refuse to allo-HSCT, intermediate-dose cytarabine (2g/m2 q12h days 1-3) for 4 cycles. If patients with intermediate or poor risk or favorable risk but MRD positive, intermediate-dose cytarabine for 1-2 cycles and follow up with allo-HSCT. For patients with FLT3 mutation, gilteritinib can be combined with the follow-up treatment after the end of initial induction.
Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Gilteritinib

What is being measured

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

  1. Overall response rate (ORR)

    Complete remission/complete remission with incomplete count recovery/Morphologic Leukemia Free State

    Measured: From randomization to 2 cycles of induction before consolidation therapy（100 days）

Secondary outcomes (5)

  1. Incidence of severe infection (>=grade 3 )

    Assessed using CTCAE 5

    Measured: From randomization to 2 cycles of induction before consolidation therapy（100 days）

  2. Duration of myelosuppression

    The duration of absolute value of peripheral blood neutrophils <0.5×10^9/L and platelet count <50×10^9/L during myelosuppression.

    Measured: From randomization to 2 cycles of induction before consolidation therapy（100 days）

  3. Event free survival

    Events include progressive disease, relapse, changes in treatment regimens, fatal or intolerable side effects and any death.

    Measured: From the time from randomization to time for up to 2 years

  4. Overall survival

    Overall survival

    Measured: From the time from randomization to time for up to 2 years

  5. Rate of Minimal Residual Disease (MRD) negativity

    Percentage of participants who converted to MRD < 10^-3 before initiation of consolidation therapy.

    Measured: From randomization to 2 cycles of induction before consolidation therapy（100 days）

Timeline

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

  1. First posted5 Jan 2022
  2. Study start1 Mar 2022
  3. Primary completion28 Feb 2024
  4. Study completion31 Dec 2024 (estimated)

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
Model description
De novo adult AML patients randomly assigned to two induction treatment groups: venetoclax+decitabine group and conventional idarubicin(12mg/m2)+cytarabine group.
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05177731
Sponsor's protocol ID
SZ-AML02
Status last verified
Oct 2024
First submitted
27 Dec 2021
Last updated
3 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Lu J, Xue SL, Wang Y, He XF, Hu XH, Miao M, Zhang Y, Tang ZX, Xie JD, Yang XF, Xu MZ, Shen YY, Du F, Wu Q, Xue MX, Wang Y, Deng AL, Dou XQ, Xu Y, Dai HP, Wu DP, Chen SN. Venetoclax and decitabine vs intensive chemotherapy as induction for young patients with newly diagnosed AML. Blood. 2025 May 29;145(22):2645-2655. doi: 10.1182/blood.2024027217.

    PubMed 40009498

  • Waclawiczek A, Leppa AM, Renders S, Stumpf K, Reyneri C, Betz B, Janssen M, Shahswar R, Donato E, Karpova D, Thiel V, Unglaub JM, Grabowski S, Gryzik S, Vierbaum L, Schlenk RF, Rollig C, Hundemer M, Pabst C, Heuser M, Raffel S, Muller-Tidow C, Sauer T, Trumpp A. Combinatorial BCL2 Family Expression in Acute Myeloid Leukemia Stem Cells Predicts Clinical Response to Azacitidine/Venetoclax. Cancer Discov. 2023 Jun 2;13(6):1408-1427. doi: 10.1158/2159-8290.CD-22-0939.

    PubMed 36892565

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Venetoclax, Decitabine for Injection and Cytarabine in people with AML, Adult and Chemotherapy Effect, run by Chen Suning 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Oct 2024. 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?

Results are not available in the source record.

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?

Overall response rate (ORR) (time frame: From randomization to 2 cycles of induction before consolidation therapy（100 days）). 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 NCT05177731, which also lists 2 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 3 Oct 2024.

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