A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Oral Venetoclax Tablets in Combination With Subcutaneously (SC) or Intravenously (IV) Injected Azacitidine in Colombia

Last updated: August 8, 2024
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Acute Myeloid Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT05587049
P23-469
  • Ages > 18
  • All Genders

Study Summary

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax in combination with azacitidine works to treat AML in adult participants in Colombia.

Venetoclax in combination with azacytidine is approved to treat Acute myeloid leukemia (AML). All study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML will be enrolled. Around 70 participants will be enrolled in the study in Colombia.

Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) or intravenous (IV) injection according to the approved local label. The duration of the study is approximately 36 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed acute myeloid leukemia (AML) defined as participants that havehistological 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 yearswho have comorbidities that preclude use of intensive induction chemotherapy.

  • Participants starting treatment with venetoclax in combination with azacytidinetreated according to the Colombia label and who are not completed the first cycle (Cycle 28 days).

Exclusion

Exclusion Criteria:

  • Participating in an interventional clinical trial within 30 days prior to Venetoclaxtreatment initiation.

Study Design

Total Participants: 70
Study Start date:
November 30, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • IPS Universitaria /ID# 248562

    Medellin, Antioquia 50010
    Colombia

    Site Not Available

  • Organizacion Clinica Bonnadona - Prevenir S.A.S. /Id# 248446

    Barranquilla, Atlantico 080003
    Colombia

    Site Not Available

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

    Valledupar, Cesar 200001
    Colombia

    Active - Recruiting

  • Clinica del Country /ID# 248430

    Bogota, Cundinamarca 110231
    Colombia

    Active - Recruiting

  • Fundacion Santa Fe de Bogota /ID# 248563

    Bogota, Cundinamarca 11011
    Colombia

    Active - Recruiting

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

    Bogota DC, Cundinamarca 111221
    Colombia

    Active - Recruiting

  • Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 248570

    Bogota DC, Cundinamarca 111221
    Colombia

    Site Not Available

  • Hospital Alma Mater de Antioquia /ID# 248562

    Medellin, Distrito Capital De Bogota 50010
    Colombia

    Active - Recruiting

  • Fundacion Valle Del Lili /ID# 248294

    Cali, Valle Del Cauca 760032
    Colombia

    Active - Recruiting

  • Hospital Pablo Tobón Uribe /ID# 248569

    Medellín, Valle Del Cauca 050034
    Colombia

    Active - Recruiting

  • Hospital Pablo Tobon Uribe /ID# 248569

    Medellin, 50034
    Colombia

    Active - Recruiting

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