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Shorter treatment course may ease side effects for AML patients

NCT ID NCT05833438

Disease control Sponsor: University of Leipzig Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new way of giving two drugs—venetoclax and azacitidine—to adults with acute myeloid leukemia (AML) who are not healthy enough for standard chemotherapy. Instead of the usual 7 days of azacitidine, this approach uses only 5 days per cycle to try to reduce infections and hospital stays. The goal is to see if the shorter regimen still works well while being easier to tolerate.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

May 2026

An estimate. End dates often move.

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

18 years and older

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.

Key Inclusion Criteria: * Confirmed diagnosis of AML by World Health Organization (WHO) criteria 2016 * Ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or comorbidities * Age ≥ 18 years * Life expectancy of at least 12 weeks Key Exclusion Criteria: * Prior treatment for AML or myelodysplastic syndrome (MDS) with one of the following: * Hypomethylating agent (HMA) * Chemotherapeutic agent * Chimeric Antigen Receptor (CAR)-T cell therapy * Experimental therapies * Note: Prior use of hydroxyurea is allowed * History of myeloproliferative neoplasm (MPN) * Diagnosis of acute promyelocytic leukemia (APL) * Presence of favorable-risk karyotype abnormalities: t(15;17), t(8;21), inv(16) or t(16;16)

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia hematologic disorder

As listed by the trial registrant

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

Acute myeloid leukemia (AML)

Contacts and locations

Locations

  • Carl-Thiem-Klinikum Cottbus gGmbH

    Cottbus, 03048, Germany

  • Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation

    Berlin, 13125, Germany

  • Kliniken Maria Hilf GmbH, Klinik für Hämatologie, Onkologie und Gastroenterologie

    Mönchengladbach, 41063, Germany

  • Kliniken Sindelfingen,Medizinische Klinik I

    Sindelfingen, 71065, Germany

  • Klinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill

    Chemnitz, 09116, Germany

  • Klinikum rechts der lsar der TU München, Klinik und Poliklinik für lnnere Medizin Ill

    München, 81675, Germany

  • Rotkreuzklinikum München, III. Medizinische Abteilung

    München, 80364, Germany

  • Universitatsklinikum Carl Gustav Carus Dresden an der TU Dresden Medizinische Klinik und Poliklinik 1 Bereich Hamatologie

    Dresden, 01307, Germany

  • Universitätsklinikum Heidelberg, Innere Medizin V; Klinik für Hämatologie, Onkologie und Rheumatologie

    Heidelberg, 69120, Germany

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie

    Leipzig, Germany

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