Acute Myeloid Leukemia
Conditions
Brief summary
The main purpose of this study is to learn about the safety and tolerability of an experimental drug, Venetoclax, when it is given along with Decitabine in subjects diagnosed with acute myeloid leukemia (AML).
Interventions
DRUGDecitabine
Decitabine will be administered intravenously at a dose of 20mg per day for 10 days during Cycle 1 (28 day cycle) Decitabine will be administered intravenously at a dose of 20mg per day for 10 days of Cycle 2 (28 day cycle). Decitabine will be administered intravenously at a dose of 20mg per day for 5 days of each 28 day maintenance cycle
DRUGVenetoclax
Venetoclax administered orally on days 1-21 of cycle 1, cycle 2 and maintenance (28 day cycles). Dose levels will be assigned at time of enrollment anywhere from 100mg-400mg. Dose escalation will follow the 3+3 study design.
Sponsors
University of Chicago
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Phase 1: Dose Escalation Phase 1. High risk AML, including any of the following: 1. Relapsed or refractory disease 2. TP53 mutant AML 3. Adverse risk cytogenetics including any of the following: 3 or more abnormalities; deletions involving chromosomes 5, 7, or 17; abnormalities in chromosome 11 involving MLL; t(6;9); inv(3) or t(3;3) 2. ECOG performance status 0-2 3. Age 18 years or older 4. Adequate organ function as defined by all of the following: 1. Creatinine clearance ≥30 mL/min, determined by the Cockroft-Gault formula, or measured by a 24 hour urine collection 2. AST and ALT ≤3 x ULN and bilirubin ≤1.5 x ULN (unless considered due to Gilbert's syndrome or of non-hepatic origin i.e. leukemic involvement). 5. Patients must be at least 2 weeks from major surgery, radiation therapy, or participation in other investigational trials, and must have recovered from clinically significant toxicities related to these prior treatments. 6. Patients must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the i initiation of any screening or study specific procedures. 7. Female patients of childbearing potential must have negative results for a pregnancy test 8. Patients must be willing to use appropriate contraception * Phase 2: Dose Expansion Phase During the Phase 2 portion of the study, the subject population will be limited to patients with previously untreated AML with a mutation in TP53. All other inclusion criteria described above will apply.
Exclusion criteria
\- Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of dose limiting toxicity (DLT) | 24 months | Determine the rate of subjects who experience a dose limiting toxicity and the maximum tolerable dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of toxicity with combination regimen | 24 months | Levels of toxicity experienced with the combination regimen will be reported using data summaries of adverse events, dose limiting toxicity and other safety parameters. |
| Assessment of Overall Survival | 24 months | Survival will be measured in months from the date of subject enrollment to the date of death. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOROlatoyosi Odenike, MD
University of Chicago
Outcome results
None listed