At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of AML per WHO 2016 or high-grade myeloid neoplasm (≥10% myeloid blasts)
- ✓Biphenotypic or mixed phenotype acute leukemia eligible
- ✓Phase I newly diagnosed: adverse risk per ELN 2017
- ✓Phase I relapsed/refractory: require first or subsequent salvage therapy with detectable blasts or ≥5% bone marrow blasts or extramedullary myeloid sarcoma
- ✕Acute promyelocytic leukemia or CML in myeloid blast crisis
- ✕Known active CNS involvement with AML
- ✕Concomitant illness with likely survival <1 year
- ✕Active systemic infection unless controlled; excludes chronic HBV or HCV requiring treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Single-Center Trial Combining Venetoclax With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (CLAG-M) for Patients With AML and High-Grade Myeloid Neoplasms
In Brief
A Phase 2 clinical trial evaluating Cladribine, Cytarabine, and 6 other interventions for Acute Biphenotypic Leukemia and 12 related conditions. Currently recruiting, targeting 62 participants across 1 site.
Detailed Summary
This phase I/II trial finds the best dose, side effects and how well giving venetoclax in combination with cladribine, cytarabine, granulocyte colony-stimulating factor, and mitoxantrone (CLAG-M) in treating patients with acute myeloid leukemia and high-grade myeloid neoplasms. Venetoclax 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 mitoxantrone, 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 CLAG-M may kill more cancer cells.
Study Details
Timeline
Interventions
Given IV
Given IV
Given IV
Given subcutaneously
Given PO
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Undergo blood sample collection