Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE2 | RECRUITING | 40 | — | — | Jan 3, 2025 | May 1, 2028 | Apr 13, 2026 | 2 | United States |
CRc is defined as achievement of complete remission (CR), CR with partial hematologic recovery (CRh) or CR with incomplete blood count recovery (CRi) after induction (or re-induction). The CRc rate will be computed on the safety set and presented with a point-estimate and exact binomial 95% confidence interval (CI). CRc will also be modeled with univariable logistic regressions, applied to the efficacy set, to determine if any baseline patient or disease feature is correlated with clinical response.
| Arm | Type | Description |
|---|---|---|
| Treatment (venetoclax, cladribine, cytarabine, azacitidine) | EXPERIMENTAL | See Detailed Description |
| Name | Type | Description |
|---|---|---|
| Azacitidine | DRUG | Given IV or SC |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow aspiration and biopsy |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow aspiration and biopsy |
| Cladribine | DRUG | Given IV |
| Cytarabine | DRUG | Given SC |
| Echocardiography | PROCEDURE | Undergo ECHO |
| Lumbar Puncture | PROCEDURE | Undergo LP |
| Multigated Acquisition Scan | PROCEDURE | Undergo MUGA |
| Questionnaire Administration | OTHER | Ancillary studies |
| Venetoclax | DRUG | Given PO |
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 con...