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Can a pill plus injection tame a tough blood cancer?

NCT ID NCT05587049

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study looks at how well a combination of two drugs—venetoclax (a pill) and azacitidine (an injection)—works for adults newly diagnosed with acute myeloid leukemia (AML), a cancer of the blood and bone marrow. The participants are people who are older or have health issues that make intensive chemotherapy too risky. The study follows about 70 patients in Colombia during their routine care to see how long they live and whether they achieve remission, while also checking safety.

What this could mean

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

Active substance
venetoclax combined with azacitidine
What this could lead to
If successful, this could confirm that the combination works well in everyday practice, offering a viable treatment option for AML patients who cannot undergo intensive chemotherapy.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient differences. The combination may not work for everyone and can cause side effects.

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.

Participants

About 70 people

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

Started

Nov 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Newly diagnosed AML participants who are ineligible to intensive chemotherapy, that starting treatment with Venetoclax in combination with azacytidine treated according to the Colombia label.

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.

Inclusion Criteria: * Newly diagnosed acute myeloid leukemia (AML) defined as participants that have histological confirmation of AML (de novo, secondary) by World Health Organization (WHO) criteria, and have not received any prior treatment for AML. * Ineligible to intensive chemotherapy due to \>=75 years of age; or \>=18 to 74 years who have comorbidities that preclude use of intensive induction chemotherapy. * Participants starting treatment with venetoclax in combination with azacytidine treated according to the Colombia label and who are not completed the first cycle (Cycle 28 days). Exclusion Criteria: \- Participating in an interventional clinical trial within 30 days prior to Venetoclax treatment initiation.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia neoplasm

As listed by the trial registrant

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

Acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinica del Country /ID# 248430

    RECRUITING

    Bogota, Cundinamarca, 110231, Colombia

  • Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570

    ACTIVE_NOT_RECRUITING

    Bogota DC, Cundinamarca, 111221, Colombia

  • FOSCAL International /ID# 287252

    ACTIVE_NOT_RECRUITING

    Floridablanca, Santander Department, 681004, Colombia

  • Fundacion Santa Fe De Bogota /ID# 248563

    RECRUITING

    Bogota, Cundinamarca, 110111, Colombia

  • Fundacion Valle Del Lili /ID# 248294

    ACTIVE_NOT_RECRUITING

    Cali, Valle del Cauca Department, 760016, Colombia

  • Hospital Alma Mater de Antioquia /ID# 248562

    ACTIVE_NOT_RECRUITING

    Medellin, Bogota D.C., 50010, Colombia

  • Hospital Pablo Tobon Uribe /ID# 248569

    ACTIVE_NOT_RECRUITING

    Medellín, Antioquia, 050034, Colombia

  • Sociedad de Oncologia y Hematologia del Cesar /ID# 248615

    COMPLETED

    Valledupar, Cesar Department, 200001, Colombia

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