Study of Cladribine+Venetoclax After Failure of Venetoclax+Hypomethylating Agent in Monocytic AML
University of Colorado, Denver
Summary
Investigation of Relapsed or refractory AML with a monocytic phenotype after failure of hypomethylating agent+venetoclax
Description
This is an investigator-initiated, open label, single institution, Study to assess the efficacy of Clad/Ven following failure of HMA/Ven in AML with a monocytic phenotype. In cycle 1, subjects will receive cladribine at a dose of 5mg/m2 daily via intravenous infusion on days 1 through 5 and venetoclax 400mg daily (following standard dose escalation over the first 3 days) on days 1 through 28 of a 28 day cycle. A bone marrow biopsy will be performed to assess response on day 28 of cycle 1. Subjects who respond to cycle 1, defined as achieving a CR, CRi, MLFS, or PR per ELN criteria, or a blast…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: A subject will be eligible for study participation if they meet the following criteria within 28 days prior to the first day of treatment. Historical records are permitted per investigator discretion. 1. Subject must have confirmation of non-acute promyelocytic leukemia (APL) Acute Myeloid Leukemia (AML) with a monocytic or monoblastic phenotype or a Ras pathway mutation. The subject's AML must be relapsed after or refractory to prior treatment with hypomethylating agent (HMA) and venetoclax combination. Note: other prior line(s) of therapy including stem cell transpl…
Interventions
- DrugCladribine
A medication used to treat hairy cell leukemia (leukemic reticuloendotheliosis) and B-cell chronic lymphocytic leukemia. Cladribine, sold under the brand name Mavenclad, is used for the treatment of adults with highly active forms of relapsing-remitting multiple sclerosis.
- DrugVenetoclax
A medication used to treat adults with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or acute myeloid leukemia (AML).
- DrugAzacitidine
Medication used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia. It is a chemical analog of cytidine, a nucleoside in DNA and RNA.. Azacitidine and its deoxy derivative, decitabine were first synthesized in Czechoslovakia as potential chemotherapeutic agents for cancer.
Location
- Universtiy of Colorado HospitalAurora, Colorado