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
| NCT ID | NCT06504459 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | OHSU Knight Cancer Institute |
| Condition | Acute Monocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-01-03 |
| Primary Completion | 2027-10-11 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Ability to comprehend the investigational nature of the study and provide informed consent (i.e., participant or legally authorized representative \[LAR\]). Written informed consent must be obtained prior to any study-specific procedures or interventions • Sign informed consent for the #4422 Biorepository prior to any study-specific procedures of interventions * Eligible AML patients of all races and ethnic groups will be considered for participation, irrespective of gender identity * Newly diagnosed, histologically confirmed monocytic AML, as defined by World Health Organization (WHO), or active signaling mutated AML defined as AML with mutation(s) to N/KRAS, FLT3 ITD/TKD, NF1, PTPN11 or CBL * Ineligible for standard of care induction therapy using intensive chemotherapy (IC) or unwilling to undergo IC induction therapy. Ineligible for IC is defined as * ≥ 75 yrs of age; OR * 18-74 yrs of age with one of the following: * Eastern Cooperative Oncology Group (ECOG)
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