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New drug cocktail shows promise for rare bone marrow cancer

NCT ID NCT02942290

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This early-stage trial tests a combination of two drugs, venetoclax and azacitidine, in people with a serious type of myelodysplastic syndromes (MDS) who have not had treatment before. The goal is to find the safest dose and see how well the drugs work together to control the disease. About 129 adults with higher-risk MDS will take part.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

134 people

The number who actually took part.

Started

Jan 2017

Finished

Apr 2026

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: * Participant must have documented diagnosis of untreated de novo MDS with: * International Prognostic Scoring System (IPSS) risk categories Int-2 or High (minimum IPSS overall score of 1.5) OR Revised IPSS (IPSS-R) categories intermediate, high or very high (score of \> 3) and * Presence of less than 20% bone marrow blasts per bone marrow biopsy/aspirate. * Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2. Exclusion Criteria: * Participant has received prior therapy for MDS. (Prior supportive care in form of transfusions or growth factors, etc., is not considered prior therapy). * Participant has received prior therapy with a BCL-2 Homology 3 (BH3) mimetic. * Participant has a diagnosis other than previously untreated de novo MDS (as defined in the protocol) including: * MDS with IPSS risk categories Low or Int-1 (overall IPSS score \< 1.5) * Therapy-related MDS (t-MDS). * MDS evolving from a pre-existing myeloproliferative neoplasm (MPN). * MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN. * Participant has received allogeneic Hematopoietic Stem Cell Transplantation (HSCT) or solid organ transplantation. * Participant has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

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

Myelodysplastic syndromes (MDS)

Contacts and locations

Locations

  • Austin Health /ID# 154955

    Heidelberg, Victoria, 3084, Australia

  • Calvary Mater Newcastle /ID# 154957

    Waratah, New South Wales, 2298, Australia

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 153828

    Nantes, Pays de la Loire Region, 44000, France

  • Columbia University Medical Center /ID# 153661

    New York, New York, 10032-3729, United States

  • Concord Repatriation General Hospital /ID# 154958

    Concord, New South Wales, 2139, Australia

  • Dana-Farber Cancer Institute /ID# 152735

    Boston, Massachusetts, 02215, United States

  • Duplicate_Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 153764

    Rome, Roma, 00161, Italy

  • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 153763

    Bologna, Emilia-Romagna, 40138, Italy

  • Duplicate_Princess Alexandra Hospital /ID# 154990

    Woolloongabba, Queensland, 4102, Australia

  • Duplicate_St. Vincent's Hospital, Darlinghurst /ID# 222846

    Darlinghurst, New South Wales, 2010, Australia

  • Duplicate_Universitaetsklinikum Carl Gus /ID# 153958

    Dresden, Saxony, 01307, Germany

  • Duplicate_University of Arizona Cancer Center - North Campus /ID# 154155

    Tucson, Arizona, 85719-1478, United States

  • Fiona Stanley Hospital /ID# 222847

    Murdoch, Western Australia, 6150, Australia

  • Hôpital Saint-Louis /ID# 153827

    Paris, 75010, France

  • Juravinski Cancer Centre /ID# 152947

    Hamilton, Ontario, L8V 1C3, Canada

  • King's College Hospital NHS Foundation Trust /ID# 156489

    London, SE5 9RS, United Kingdom

  • Klinikum rechts der Isar /ID# 153139

    Munich, Bavaria, 81675, Germany

  • Liverpool Hospital /ID# 222410

    Liverpool, New South Wales, 2170, Australia

  • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 156492

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • Oregon Medical Research Center /ID# 152734

    Portland, Oregon, 97239, United States

  • Oxford University Hospitals NHS Foundation Trust /ID# 222567

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • St George Hospital /ID# 154954

    Kogarah, New South Wales, 2217, Australia

  • Tennessee Oncology-Nashville Centennial /ID# 222769

    Nashville, Tennessee, 37203-1632, United States

  • The Alfred Hospital /ID# 154956

    Melbourne, Victoria, 3004, Australia

  • The University of Chicago Medical Center /ID# 153673

    Chicago, Illinois, 60637-1443, United States

  • Tufts Medical Center /ID# 153672

    Boston, Massachusetts, 02111-1552, United States

  • UT MD Anderson Cancer Center /ID# 153809

    Houston, Texas, 77030, United States

  • Universitaetsklinikum Halle (Saale) /ID# 153760

    Halle, 06120, Germany

  • Universitaetsklinikum Koeln /ID# 153141

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitaetsklinikum Leipzig /ID# 153142

    Leipzig, Saxony, 04103, Germany

  • Universitatsklinikum Mannheim /ID# 153140

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • University Hospitals Birmingham NHS Foundation Trust /ID# 158810

    Birmingham, B15 2TH, United Kingdom

  • University of Maryland, Baltimore /ID# 153669

    Baltimore, Maryland, 21201, United States

  • University of Pittsburgh MC /ID# 153662

    Pittsburgh, Pennsylvania, 15260, United States

  • Vanderbilt University Medical Center /ID# 152738

    Nashville, Tennessee, 37232-0011, United States

  • Washington University-School of Medicine /ID# 153671

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College /ID# 155524

    New York, New York, 10065, United States

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