CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Azacitidine +1 moredrug
Likely dose
Azacitidine (IV or SC) + CB-839 (PO)AI-extracted
Key inclusion· 7
  • ✓Histologically confirmed MDS, RAEB-T (AML with 20-30% blasts and multilineage dysplasia), or CMML
  • ✓High-risk MDS (IPSS Intermediate-2 or high-risk; R-IPSS high or very-high risk); or Intermediate-1 IPSS/Intermediate R-IPSS with IDH1/IDH2 or TP53/ASXL1/EZH2/RUNX1 mutations
  • ✓ECOG performance status 0-2
  • ✓Serum bilirubin ≤2 × ULN (except Gilbert's disease)
Key exclusion· 10
  • ✕Any prior or coexisting medical condition that substantially increases study risk
  • ✕Psychiatric disorders or altered mental status precluding informed consent or study compliance
  • ✕Active uncontrolled infection, including HIV, or chronic active hepatitis B or C
  • ✕Clinically significant GI conditions or disorders interfering with drug absorption, including prior gastrectomy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03047993
NCT03047993Phase 2Completed
CompareCT.gov

Phase Ib/II Study of the Glutaminase Inhibitor CB-839 in Combination With Azacitidine in Patients With Advanced Myelodysplastic Syndrome

M.D. Anderson Cancer Center·interventional·Posted Feb 9, 2017·Updated May 14, 2024

In Brief

A Phase 2 clinical trial evaluating Azacitidine and Glutaminase Inhibitor CB-839 for Acute Myeloid Leukemia With Multilineage Dysplasia and 6 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia With Multilineage Dysplasia, Blasts 20-30 Percent of Bone Marrow Nucleated Cells, Blasts 20-30 Percent of Peripheral Blood White Cells, Chronic Myelomonocytic Leukemia, High Risk Myelodysplastic Syndrome, IPSS Risk Category Intermediate-2, Myelodysplastic Syndrome
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 9, 2017
Enrollment StartNov 15, 2017
Primary CompletionMar 16, 2023
TodayJul 1, 2026
Enrollment to primary: 5.3 yearsPosted 9.4 years ago

Interventions

Azacitidinedrug

Given IV or SC

Glutaminase Inhibitor CB-839drug

Given PO