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Acute Myeloid LeukemiaPhase 1/2NCT05893472

A Study on the Efficacy and Safety of Venetoclax Combined With HAA Regimen in Newly Diagnosed Young AML.

A Phase 1/2 study testing combination of venetoclax and HAA regimen in people with Acute Myeloid Leukemia and Venetoclax, run by ZePing Zhou 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to investigate the efficacy and safety of the combination of venetoclax and HAA regimen in young, newly diagnosed acute myeloid leukemia patients under the age of 60. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Acute Myeloid Leukemia, Venetoclax
What is being tested?
combination of venetoclax and HAA regimen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
1 Apr 2023to 1 Apr 2024
Phase
Phase 1/2
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 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • The eligible subjects for enrollment in this study must meet all of the following criteria:
  • Patients with acute myeloid leukemia (excluding APL) who meet the diagnostic criteria of the World Health Organization (WHO) 2016 classification.
  • Patients with AML and multilineage dysplasia (MDS) and/or myeloproliferative neoplasms (MPN) who meet the WHO criteria without prior history of MDS or MPN.
  • Patients with AML who are not classified separately according to the WHO classification, except for those with acute megakaryoblastic leukemia with bone marrow fibrosis or myeloid sarcoma.
  • Age greater than 16 years and less than 60 years, regardless of gender.
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2.
  • Requirements for laboratory parameters (within 7 days prior to treatment initiation) include: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3 times the upper limit of normal (ULN); serum bilirubin ≤2×ULN; serum cardiac enzyme <2.0×ULN; serum creatinine ≤2.0×ULN; and echocardiogram (ECHO)-determined ejection fraction within the normal range.
  • A signed informed consent form is required before any study-specific procedures are performed. Patients 18 years and older may sign the informed consent form themselves or have it signed by their next of kin. Patients under 18 years of age must have the informed consent form signed by their legal guardian. In consideration of the patient's medical condition, if it is not in the patient's best interest to sign the form, the legal guardian or patient's next of kin may sign the form on the patient's behalf.

Who cannot join

  • Subjects meeting any of the following criteria will be excluded from this study:
  • Previously treated patients (including those who have undergone induction chemotherapy regardless of treatment response).
  • Secondary leukemia (including therapy-related AML subtype according to the World Health Organization (WHO) classification and those with a history of MDS and/or MPD).
  • Concomitant hematologic diseases (such as hemophilia or myelofibrosis) deemed unsuitable for inclusion by the investigator; individuals with prior abnormal blood counts are allowed to participate if they have been previously excluded from MDS and MPD.
  • Other malignant tumors requiring treatment.
  • Pregnant or lactating women. Female participants of childbearing potential must have a negative pregnancy test within 7 days prior to the start of the trial. Male or female participants must take contraceptive measures during the trial and for 3 years after completion of treatment.
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  • Significant abnormalities in liver or kidney function beyond the inclusion criteria.
  • Active heart disease, defined as one or more of the following:
  • <!-- -->
  • History of uncontrolled or symptomatic angina pectoris;
  • Myocardial infarction within 6 months prior to enrollment;
  • History of arrhythmia requiring medication or with severe clinical symptoms;
  • Uncontrolled or symptomatic congestive heart failure (> NYHA class 2);
  • Ejection fraction below the lower limit of the normal range. 8. Severe infectious diseases (e.g., unhealed tuberculosis or pulmonary aspergillosis).
  • 9. Participants deemed unsuitable for inclusion by the investigator.

Trial locations and contacts

1 site in 1 country.

ZePing Zhou, Dr contact

18788571605

zhouzeping@kmmu.edu.cn

yaxian tan contact

18208821198

353964619@qq.com

China1 site, 1 recruiting

  • The Second Affiliated Hospital of Kunming Medical University.

    Kunming, Yunnan

    DanQi Deng, Dr, 087165351281, kycyjszx@public.km.yn.cn

    Recruiting

Other trials in China

About this study

Official title: The Second Affiliated Hospital of Kunming Medical University

The purpose of this study is to investigate the efficacy and safety of the combination of venetoclax and HAA regimen in young, newly diagnosed acute myeloid leukemia patients under the age of 60.

Being tested
combination of venetoclax and HAA regimen
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.

  • combination of venetoclax and HAA regimenCombination product

    Using the combination of venetoclax and HAA regimen as induction therapy in young, newly diagnosed adult acute myeloid leukemia patients under the age of 60.

Study groups in NCT05893472
Study groupRoleWhat they receive
The treatment group receiving the combination of venetoclax and HAA regimen.ExperimentalReceived induction therapy protocol： Docetaxel (HHT) 2.5mg/㎡/day, days 3-7 Aclarubicin (Acla) 20mg/day, days 3-7 Cytarabine (Ara-c) 100mg/㎡/day, days 3-7 (given as a 24-hour infusion) Venetoclax (VEN): 100mg on day 1, 200mg on day 2, and 400mg on days 3-8.
Receives: Combination Product: combination of venetoclax and HAA regimen

What is being measured

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

  1. Overall response rate (ORR)

    which evaluates the efficacy of patient induction therapy, including complete remission (CR), complete remission with incomplete blood count recovery (CRi), and morphologic leukemia-free state (MLFS)

    Measured: up to 12 months

Secondary outcomes (5)

  1. Minimal residual disease (MRD)

    MRD percentage

    Measured: up to 12 months

  2. overall survival (OS)

    Overall Survival (OS) is used to evaluate all patients enrolled in a clinical trial, from the date of enrollment until death from any cause or the date of last follow-up for surviving patients.

    Measured: up to 12 months

  3. relapse-free survival (RFS)

    Relapse-Free Survival (RFS) is only used to evaluate patients who achieve complete remission (CR) through reinduction therapy. RFS is defined as the time from achievement of CR until death from any cause, relapse, or the date of last follow-up.

    Measured: up to 12 months

  4. 30-day mortality rate

    The 30-day mortality rate is used to evaluate all patients enrolled in a clinical trial, and is defined as the percentage of patients who die within 30 days of starting chemotherapy.

    Measured: Within 30 days after starting the medication

  5. adverse drug reactions

    Adverse drug reactions during chemotherapy and follow-up

    Measured: up to 12 months

Timeline

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

  1. First posted8 Jun 2023
  2. Study start1 Apr 2023
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Apr 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05893472
Sponsor's protocol ID
SHEN-PJ-KE-2023-125
Status last verified
May 2023
First submitted
24 Apr 2023
Last updated
8 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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, 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

  • Wei AH, Strickland SA Jr, Hou JZ, Fiedler W, Lin TL, Walter RB, Enjeti A, Tiong IS, Savona M, Lee S, Chyla B, Popovic R, Salem AH, Agarwal S, Xu T, Fakouhi KM, Humerickhouse R, Hong WJ, Hayslip J, Roboz GJ. Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study. J Clin Oncol. 2019 May 20;37(15):1277-1284. doi: 10.1200/JCO.18.01600. Epub 2019 Mar 20.

    PubMed 30892988

  • 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

  • Jin J, Wang JX, Chen FF, Wu DP, Hu J, Zhou JF, Hu JD, Wang JM, Li JY, Huang XJ, Ma J, Ji CY, Xu XP, Yu K, Ren HY, Zhou YH, Tong Y, Lou YJ, Ni WM, Tong HY, Wang HF, Mi YC, Du X, Chen BA, Shen Y, Chen Z, Chen SJ. Homoharringtonine-based induction regimens for patients with de-novo acute myeloid leukaemia: a multicentre, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2013 Jun;14(7):599-608. doi: 10.1016/S1470-2045(13)70152-9. Epub 2013 May 9.

    PubMed 23664707

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing combination of venetoclax and HAA regimen in people with Acute Myeloid Leukemia and Venetoclax, run by ZePing Zhou 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 8 inclusion and 15 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 8 Jun 2023. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact ZePing Zhou, Dr (18788571605, zhouzeping@kmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (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 NCT05893472, which also lists 7 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 8 Jun 2023.

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