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New hope for AML patients in india: drug combo aims for remission without intensive chemo

NCT ID NCT07044687

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study tests a combination of two drugs, venetoclax and azacitidine, in about 100 adults in India with newly diagnosed acute myeloid leukemia (AML) who are not healthy enough for standard intensive chemotherapy. The goal is to see if the combo can put the cancer into remission and to track side effects. Participants take venetoclax pills daily and receive azacitidine injections for a week each cycle, with regular checkups over about 29 months.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

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

Started

Jul 2025

Expected to finish

Nov 2027

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.

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: * Confirmation of acute myeloid leukemia (AML) diagnosis by 2016 World Health Organization (WHO) criteria, previously untreated, and ineligible for treatment with intensive chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status of: * 0 to 2 for subject ≥ 75 years of age. * 0 to 3 for subject ≥ 18 to 74 years of age. Exclusion Criteria: * History of any malignancy within 2 years prior to study entry with exception to those noted in the protocol. * Have received any investigational drug 30 days prior to the first dose of study drug and have received strong CYP3A inducers within 7 days prior to the initiation of study treatment.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

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

    11 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

  • All India Institute Of Medical Sciences - Bhubaneswar /ID# 274879

    RECRUITING

    Bhubaneswar, Odisha, 751019, India

  • All India Institute Of Medical Sciences - New Delhi /ID# 268357

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Apollo Cancer Centre /ID# 268780

    RECRUITING

    Chennai, Tamil Nadu, 600035, India

  • Basavatarakam Indo American Cancer Hospital & Research Institute /ID# 268692

    RECRUITING

    Hyderabad, Telangana, 500034, India

  • Cancer Institute (Wia) /ID# 268695

    RECRUITING

    Chennai, Tamil Nadu, 600036, India

  • Christian Medical College Vellore /ID# 279587

    RECRUITING

    Vellore, Tamil Nadu, 632004, India

  • Fortis Memorial Research Institute /ID# 268697

    COMPLETED

    Gurgaon, Haryana, 122002, India

  • Healthcare Global Enterprises Limited (HCGEL) /ID# 272071

    COMPLETED

    Bengaluru, Karnataka, 560027, India

  • LMMF's Deenanath Mangeshkar Hospital & Research Center /ID# 268781

    RECRUITING

    Pune, Maharashtra, 411004, India

  • Mazumdar Shaw Medical Center /ID# 270677

    RECRUITING

    Bengaluru, Karnataka, 560099, India

  • Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293

    COMPLETED

    New Delhi, National Capital Territory of Delhi, 110085, India

  • Regional Cancer Centre /ID# 268785

    RECRUITING

    Thiruvananthapuram, Kerala, 695011, India

  • Sahyadri Super Speciality Hospital /ID# 272074

    RECRUITING

    Pune, Maharashtra, 411044, India

  • Tata Memorial Hospital - Mumbai /ID# 269177

    RECRUITING

    Mumbai, Maharashtra, 400012, India

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