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

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

Key Inclusion Criteria:

* Confirmed diagnosis of AML by World Health Organization (WHO) criteria 2016
* Ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or comorbidities
* Age ≥ 18 years
* Life expectancy of at least 12 weeks

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) or t(16;16)

Conditions2

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