Status:
RECRUITING
Venetoclax in Combination with 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
AbbVie
University Hospital Leipzig, Hematology Diagnostics Laboratory
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Germa...
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 a...
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)
Key Trial Info
Start Date :
May 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05833438
Start Date
May 17 2023
End Date
July 1 2025
Last Update
December 9 2024
Active Locations (10)
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1
Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation
Berlin, Germany, 13125
2
Klinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill
Chemnitz, Germany, 09116
3
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus, Germany, 03048
4
Universitatsklinikum Carl Gustav Carus Dresden an der TU Dresden Medizinische Klinik und Poliklinik 1 Bereich Hamatologie
Dresden, Germany, 01307