Venetoclax in Combination with 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy

Last updated: December 4, 2024
Sponsor: University of Leipzig
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Leukemia (Pediatric)

Treatment

VEN+AZA-5

Clinical Study ID

NCT05833438
VENAZA-5S
2022-501537-23-00
  • Ages > 18
  • All Genders

Study Summary

Acute myeloid leukemia (AML): continuous oral Venetoclax (VEN) and 7 days of s.c. Azacitidine (AZA) per 28-day cycle = standard of care for intensive induction therapy ineligible AML patients in Germany

The VENAZA-5S pilot trial: AZA administration reduced to 5 days within each cycle to improve tolerability and treatment adherence due to less neutropenic infections, less treatment interruptions and less hospitalizations.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Confirmed diagnosis of AML by World Health Organization (WHO) criteria 2016

  • Ineligible for treatment with a standard cytarabine and anthracycline inductionregimen due to age or comorbidities

  • Age ≥ 18 years

  • Life expectancy of at least 12 weeks

Exclusion

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) ort(16;16)

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: VEN+AZA-5
Phase: 2
Study Start date:
May 17, 2023
Estimated Completion Date:
July 31, 2025

Study Description

Acute myeloid leukemia (AML) is a uniformly fatal disease if untreated. The combination of continuous oral Venetoclax (VEN) and 7 days of s.c. Azacitidine (AZA) per 28-day cycle has recently emerged as the new standard of care for AML patient who are ineligible for intensive induction therapy, and has been widely adopted in Germany.

The VENAZA-5S pilot trial aims to reduce the reported hematological toxicity profile of this currently approved combination, while preserving efficacy, by modifying AZA administration to 5 days within each cycle. The hypothesis is that this modification will not interfere with the response rates achieved by the combination, but will rather improve tolerability and treatment adherence due to less neutropenic infections, less treatment interruptions and hospitalizations, and thus result in better quality of life and favorable long-term outcomes in elderly or comorbid AML patients. This single-arm pilot study is intended to generate first data on the efficacy and toxicity of 5 days AZA

  • VEN, which will be compared to a historical control cohort treated with the current standard of 7 days AZA + VEN.

Connect with a study center

  • Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation

    Berlin, 13125
    Germany

    Active - Recruiting

  • Klinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill

    Chemnitz, 09116
    Germany

    Site Not Available

  • Carl-Thiem-Klinikum Cottbus gGmbH

    Cottbus, 03048
    Germany

    Active - Recruiting

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

    Dresden, 01307
    Germany

    Site Not Available

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

    Heidelberg, 69120
    Germany

    Site Not Available

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

    Leipzig,
    Germany

    Active - Recruiting

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

    Mönchengladbach, 41063
    Germany

    Site Not Available

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

    München, 81675
    Germany

    Site Not Available

  • Rotkreuzklinikum München, III. Medizinische Abteilung

    München, 80364
    Germany

    Active - Recruiting

  • Kliniken Sindelfingen,Medizinische Klinik I

    Sindelfingen, 71065
    Germany

    Site Not Available

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