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

NCT05833438 | Active Not Recruiting Phase 2

• 2 other identifiers: VENAZA-5S2022-501537-23-00
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Venclyxto; Venetoclax; Azacitidine; Hematologic Diseases; Acute Myelogenous Leukemia

Outcome Measures

Primary Outcomes (1)

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

  Bone marrow assessments will be performed at least at screening, at the end of cycle 1, after cycle 4 and after cycle 6 resp. end of treatment (EOT). Criteria for disease status / response assessment follow the ELN-2022 recommendations .

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

Secondary Outcomes (12)

• Rate of CR or CRi by the Initiation of Cycle 2

  At the end of Cycle 1 (each cycle is 28 days)

• Rate of CR with partial hematologic recovery (CRh) after up to 6 cycles of therapy

  after up to 6 cycles (each cycle is 28 days)

• Time from initiation of treatment (C1D1) until achievement of CR or CRi

  from start of treatment (C1D1) until up to 6 cycles (each cycle is 28 days)

• Objective response rate

  at EOT, after up to 6 cycles therapy (each cycle is 28 days)

• Event free survival (EFS)

  From start of treatment to the date of relapse from CR or CRi, treatment failure (i.e., no CR or CRi after up to 6 cycles (each cycle is 28 days) of therapy or disease progression requiring treatment discontinuation), or death from any cause.

Other Outcomes (1)

• Incidence of Adverse Events [Safety and Tolerability]

  From start of treatment until 35±7 days after EOT

Study Arms (1)

VEN+AZA-5

EXPERIMENTAL

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

Drug: VEN+AZA-5

Interventions

VEN+AZA-5 DRUG

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)

VEN+AZA-5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AbbVie: collaborator
• University of Leipzig: lead
• University of Leipzig, Clinical Trial Centre (ZKS): collaborator
• University Hospital Leipzig, Hematology Diagnostics Laboratory: collaborator

Study Sites (10)

Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation

Berlin, 13125, Germany

Location

Klinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill

Chemnitz, 09116, Germany

Location

Carl-Thiem-Klinikum Cottbus gGmbH

Cottbus, 03048, Germany

Location

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

Dresden, 01307, Germany

Location

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

Heidelberg, 69120, Germany

Location

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

Leipzig, Germany

Location

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

Mönchengladbach, 41063, Germany

Location

Rotkreuzklinikum München, III. Medizinische Abteilung

München, 80364, Germany

Location

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

München, 81675, Germany

Location

Kliniken Sindelfingen,Medizinische Klinik I

Sindelfingen, 71065, Germany

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Hematologic Diseases

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases

Study Officials

• Klaus Metzeler, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Klaus Metzeler

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: April 27, 2023
• Study Start: May 17, 2023
• Primary Completion: November 16, 2025
• Study Completion: May 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 3 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal for individual participant data meta-analysis.

Locations

DE (10)