RecruitingPhase 2NCT05833438

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

A Single-arm, Pilot Study of Venetoclax in Combination with 5 Days Azacitidine in Treatment-naïve Subjects with Acute Myelogenous Leukemia Who Are ≥18 Years of Age and Not Eligible for Standard Induction Therapy (VENAZA-5S PILOT TRIAL)

Sponsor

University of Leipzig

Enrollment

45 participants

Start Date

May 17, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia (AML)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — venetoclax (a targeted pill) and azacitidine (a chemotherapy given over 5 days per cycle) — for older or medically frail patients newly diagnosed with acute myeloid leukemia (AML), a fast-growing blood cancer. These patients are unable to tolerate standard intensive chemotherapy. **You may be eligible if...** - You have been newly diagnosed with AML (confirmed by standard criteria) - You are 18 or older - You are not able to receive standard intensive chemotherapy due to age or health conditions - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have previously received certain treatments for AML or a related blood condition (MDS), including chemotherapy, hypomethylating agents, or CAR-T therapy - You have a specific low-risk type of leukemia (APL or favorable-risk AML) - You have a history of a myeloproliferative disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVEN+AZA-5

Up to 6 cycles: Azacitidine (AZA) 75 mg/m2, d1-5 of each 28 day cycle (SC) in combination with Venetoclax (VEN): 400 mg daily (orally)

Locations(10)

Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation

Berlin, Germany

Klinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill

Chemnitz, Germany

Carl-Thiem-Klinikum Cottbus gGmbH

Cottbus, Germany

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

Dresden, Germany

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

Heidelberg, Germany

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

Leipzig, Germany

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

Mönchengladbach, Germany

Rotkreuzklinikum München, III. Medizinische Abteilung

München, Germany

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

München, Germany

Kliniken Sindelfingen,Medizinische Klinik I

Sindelfingen, Germany

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NCT05833438

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