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New drug combo shows promise for AML patients

NCT ID NCT05471700

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a combination of two drugs, azacitidine and venetoclax, in 40 adults aged 45 to 65 with newly diagnosed acute myeloid leukemia (AML). The goal was to see how safe and effective the combo is at shrinking the cancer. Participants received the drugs in 28-day cycles, and researchers measured how many achieved remission.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
azacitidine and venetoclax
What this could lead to
If successful, this combination could offer a new treatment option for acute myeloid leukemia, potentially improving remission rates.
What could go wrong
This is a small, single-arm study with no comparison group, so results may not be definitive. Side effects from the drugs are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Sep 2022

Finished

Apr 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1.Age 45 to 65 years old,both male and female * 2.Be able to understand and sign informed consent * 3.Untreated AML patients (non-APL) diagnosed according to the 2016 World Health Organization (WHO) classification and diagnostic criteria for acute myeloid leukemia * 4.Patients with an ECOG performance status 0,1,2 or 3 * 5.Expected survival time≥3 months * 6.Laboratory indicators meet the following standards: 1. Bilrubin, ALT and AST were all less than 3 times the upper limit of normal within 7 days before the first day of treatment 2. Serum creatinine clearance rate is greater than 30ml/min Exclusion Criteria: * 1.patients participating in other interventional or observational clinical studies currently * 2.Patients has a history of myeloproliferative neoplasm \[MPN\] * 3.Patients with acute promyelocytic leukemia * 4.Active CNS involvement in patients with acute myeloid leukemia * 5.Patients with active hepatitis B or C, HIV infection before enrollment * 6.Cardiovascular status of patients evaluate by NYHA classification method \> 2 * 7.Patients have chronic respiratory disease requiring continuous oxygen treatment, or any sitiuation investigator believes will adversely affect this study (including renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular disease and known history of allergy to any study drug) * 8.Patients suffering from malabsorption syndrome or other diseases that prevent the enteral route of administration * 9.patients present with an uncontrolled systemic infection (viral, bacterial, or fungal) * 10.Patients with a history of other malignancies within 2 years before enrollment, except for the following cases: 1. Adequately treated carcinoma in situ of the cervix or carcinoma of the breast 2. Basal cell carcinoma or localized squamous cell carcinoma of skin

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Nanfang Hospital of Southern Medical University

    Guanzhou, Guandong, 510250, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.