Trial Title:
Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy
NCT ID:
NCT05833438
Condition:
Acute Myeloid Leukemia (AML)
Conditions: Official terms:
Leukemia
Leukemia, Myeloid, Acute
Conditions: Keywords:
Venclyxto
Venetoclax
Azacitidine
Hematologic Diseases
Acute Myelogenous Leukemia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
VEN+AZA-5
Description:
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)
Arm group label:
VEN+AZA-5
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.
Detailed description:
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Pearl van Heteren, Dr.
Email:
Pearl.vanHeteren@helios-gesundheit.de
Facility:
Name:
Klinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill
Address:
City:
Chemnitz
Zip:
09116
Country:
Germany
Status:
Active, not recruiting
Facility:
Name:
Carl-Thiem-Klinikum Cottbus gGmbH
Address:
City:
Cottbus
Zip:
03048
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Martin Schmidt-Hieber, PD Dr.
Email:
m.schmidt_hieber@ctk.de
Facility:
Name:
Universitatsklinikum Carl Gustav Carus Dresden an der TU Dresden Medizinische Klinik und Poliklinik 1 Bereich Hamatologie
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Active, not recruiting
Facility:
Name:
Universitätsklinikum Heidelberg, Innere Medizin V; Klinik für Hämatologie, Onkologie und Rheumatologie
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Active, not recruiting
Facility:
Name:
Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
Address:
City:
Leipzig
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Klaus Metzeler, Prof. Dr.
Email:
Klaus.Metzeler@medizin.uni-leipzig.de
Contact backup:
Email:
haematologie.studieneinheit@medizin.uni-leipzig.de
Facility:
Name:
Kliniken Maria Hilf GmbH, Klinik für Hämatologie, Onkologie und Gastroenterologie
Address:
City:
Mönchengladbach
Zip:
41063
Country:
Germany
Status:
Active, not recruiting
Facility:
Name:
Rotkreuzklinikum München, III. Medizinische Abteilung
Address:
City:
München
Zip:
80364
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Alexander Höllein, Prof.
Email:
alexander.hoellein@swmbrk.de
Facility:
Name:
Klinikum rechts der lsar der TU München, Klinik und Poliklinik für lnnere Medizin Ill
Address:
City:
München
Zip:
81675
Country:
Germany
Status:
Active, not recruiting
Facility:
Name:
Kliniken Sindelfingen,Medizinische Klinik I
Address:
City:
Sindelfingen
Zip:
71065
Country:
Germany
Status:
Active, not recruiting
Start date:
May 17, 2023
Completion date:
January 2025
Lead sponsor:
Agency:
University of Leipzig
Agency class:
Other
Collaborator:
Agency:
AbbVie
Agency class:
Industry
Collaborator:
Agency:
University Hospital Leipzig, Hematology Diagnostics Laboratory
Agency class:
Other
Collaborator:
Agency:
University of Leipzig, Clinical Trial Centre (ZKS)
Agency class:
Other
Source:
University of Leipzig
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05833438
