Active — Not RecruitingPhase 2

CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia

United States30 participantsStarted 2020-02-19

Plain-language summary

This is a phase 2 single-arm, open-label clinical trial determining efficacy of CPX-351 in combination with Glasdegib in subjects with Acute Myelogenous Leukemia with myelodysplastic syndrome related changes or therapy-related acute myeloid leukemia.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. AML arising in MDS (including CMML) or MDS/MPN syndrome
✓. AML with MDS-related cytogenetic abnormalities (Appendix A, metaphase FISH allowable as surrogate for cytogenetics)
✓. AML with multi-lineage dysplasia involving the presence of 50% or more dysplastic cells in at least two cell lines and in the absence of mutation in NPM1 or biallelic CEBPA (as per WHO 2016)
✓. Left Ventricular Ejection Fraction (LVEF) \> 50%
✓. Serum total bilirubin \< 2.0 mg/dL, unless considered due to Gilbert's disease or leukemic involvement
✓. AST, ALT and alkaline phosphatase \< 3 times the upper limit of normal, unless considered due to leukemic involvement
✓. Serum creatinine \< 2.0 mg/dL, or creatinine clearance \> 40 mL/min based on Cockcroft-Gault GFR
✓. A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

What they're measuring

Percentage of Participants With Event-Free Survival at 6 Months

Timeframe: 6 months

Trial details

NCT IDNCT04231851

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

Results submitted2026-02-13

View on ClinicalTrials.gov More Acute Myelogenous Leukemia (AML) Due to Therapy trials