Clinical trial · Interventional
Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VEN+AZA-5 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VEN+AZA-5
- description
- Azacitidine (AZA) 75 mg/m2, d1-5 of each 28 day cycle (SC) in combination with Venetoclax (VEN): 400 mg daily (orally)
- interventionNames
- Drug: VEN+AZA-5
Primary outcomes (1)
- measure
- The primary outcome measure is the response rate defined as the rate of CR/CRi after up to 6 cycles of therapy (best response).
- timeFrame
- best response after up to 6 cycles (each cycle is 28 days)
- description
- 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 .
Secondary outcomes (12)
- measure
- Rate of CR or CRi by the Initiation of Cycle 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available