Active — Not RecruitingPhase 2

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

Germany45 participantsStarted 2023-05-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

The primary outcome measure is the response rate defined as the rate of CR/CRi after up to 6 cycles of therapy (best response).

Timeframe: best response after up to 6 cycles (each cycle is 28 days)

Trial details

NCT IDNCT05833438

SponsorUniversity of Leipzig

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-16