Glutaminase Inhibitor CB-839 and Azacitidine in Treating Patients With Advanced Myelodysplastic S… (NCT03047993) | Clinical Trial Compass
CompletedPhase 1/2
Glutaminase Inhibitor CB-839 and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndrome
United States28 participantsStarted 2017-11-15
Plain-language summary
This phase I/II trial studies the side effects of glutaminase inhibitor CB-839 in combination with azacitidine in treating patients with myelodysplastic syndrome that has spread to other places in the body. Glutaminase inhibitor CB-839 and azacitidine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Signed, informed consent must be obtained prior to any study specific procedures
* Subjects with a histologically confirmed diagnosis of MDS, including both MDS and refractory anemia with excess blasts (RAEB)-T (acute myeloid leukemia \[AML\] with 20-30% blasts and multilineage dysplasia by French-American-British \[FAB\] criteria) by World Health Organization (WHO) and chronic myelomonocytic leukemia (CMML) are eligible
* Subjects with high-risk MDS (i.e. International Prognostic Scoring System \[IPSS\] Intermediate-2 or high-risk; or R-IPSS high or very-high risk). Patients with Intermediate-1 risk by IPSS or Intermediate risk by R-IPSS and with IDH1 or IDH2, or high-risk molecular features including TP53, ASXL1, EZH2, and/or RUNX1 mutations are also eligible
* Subjects with prior hypomethylating agent therapy exposure may be eligible based on discussion with the principal investigator (PI)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Serum bilirubin =\< 2 x the upper limit of normal (ULN) (except for patients with Gilbert's disease)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\< 3 x the laboratory ULN
* Creatinine clearance \> 30 mL/min based on the Cockcroft-Gault equation
* Able to understand and voluntarily sign a written informed consent, and willing and able to comply with protocol requirements
* Resolution of all treatment-related, non-hematological toxicities, except alopecia, from any previ…