OncoMatch/Clinical Trials/NCT06504459
Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML
Is NCT06504459 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Azacitidine and Cladribine for acute monocytic leukemia.
Treatment: Azacitidine · Cladribine · Cytarabine · Venetoclax — This phase II trial tests how well venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax works in treating patients with newly diagnosed monocytic acute myeloid leukemia (AML) and active signaling mutated AML. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax may kill more cancer cells in patients with newly diagnosed monocytic AML and active signaling mutated AML.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CBL mutation
Required: FLT3 itd
Required: FLT3 tkd
Required: KRAS mutation
Required: NF1 mutation
Required: NRAS mutation
Required: PTPN11 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: any AML therapy
Exception: cytoreduction for proliferative disease with hydroxyurea, hematopoietic growth factors, leukapheresis
Prior treatment for AML, with the exception of cytoreduction for proliferative disease (per institutional protocol) with any of the following: Hydroxyurea, hematopoietic growth factors, leukapheresis
Cannot have received: investigational therapy
Investigational therapy within 28 days of C1D1, or within 5 half-lives or longer, if known
Cannot have received: stem cell transplant
stem cell transplant within 100 days (and without active treatment for graft versus host disease [GVHD]) of C1D1
Cannot have received: BCL-2 inhibitor
Treatment based on agents targeting or inhibiting BCL-2 (for other, prior indication/malignancy) within the previous 5 years
Lab requirements
Kidney function
Creatinine clearance ≥ 30 ml/min (Cockcroft-Gault equation)
Liver function
Total bilirubin ≤ 1.5 x ULN (unless due to leukemic infiltration); AST/ALT ≤ 3 x ULN (unless due to leukemic infiltration or Gilbert's syndrome)
Cardiac function
No severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
If ≥ 75 yrs of age, the following organ function values must be met... Creatinine clearance (calculated with the Cockcroft-Gault equation) ≥ 30 ml/min; Total bilirubin ≤ 1.5 x ULN (Unless due to leukemic infiltration); AST/ALT ≤ 3 x ULN (Unless due to leukemic infiltration) (With the exception of documented Gilbert's syndrome or similar conditions...)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- OHSU Knight Cancer Institute · Portland, Oregon
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