Clinical trial

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)

Name

VENAZA-5S

Description

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.

Trial arms

Trial start

2023-05-17

Estimated PCD

2025-01-01

Trial end

2025-01-01

Status

Recruiting

Phase

Early phase I

Treatment

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)

Arms:

VEN+AZA-5

Size

Primary endpoint

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

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

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

Updated at

2023-08-08

1 organization

1 product

1 indication

Organization

University of Leipzig

Product

VEN+AZA-5

Indication

Acute Myeloid Leukemia