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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-17

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia (AML)

Keywords

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Venclyxto Venetoclax Azacitidine Hematologic Diseases Acute Myelogenous Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VEN+AZA-5

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

Group Type EXPERIMENTAL

VEN+AZA-5

Intervention Type 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)

Interventions

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VEN+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)

Intervention Type DRUG

Eligibility Criteria

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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

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Klaus Metzeler

Prof. Dr. med. Klaus Metzeler

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Metzeler, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation

Berlin, , Germany

Site Status RECRUITING