Active — Not RecruitingPhase 1/2

Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS

United States28 participantsStarted 2018-09-17

Plain-language summary

This study will treat patients with previously untreated high grade myleodysplastic syndromes (MDS) with both omacetaxine mepesuccinate and azacitidine.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subject must have confirmation of high grade MDS (MDS with excess blasts by WHO criteria) or chronic myelomonocytic leukemia with greater than 5% bone marrow blasts
✓. Subjects in the newly-diagnosed Phase 2 cohort must have received no prior treatment with a hypomethylating agent for MDS. Subjects in the relapsed/refractory Phase 2 cohort must have received at least 1 prior line of an HMA-containing regimen. "Refractory" is defined as having received at least four cycles of any HMA or HMA-containing regimen with \>5-19% bone marrow blasts. "Relapsed" is defined as having \>5-19% bone marrow blasts after having achieved a morphologic remission (≤5% bone marrow blasts) after at least one cycle of any HMA or HMA-containing regimen.
✓. Subject must be ≥ 18 years of age
✓. Subject must have a projected life expectancy of at least 12 weeks
✓. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤2
✓. Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula
✓. Subject must have adequate liver function as demonstrated by:
✓. Non-sterile male subjects must use contraceptive methods with partner(s) from time of enrollment and continuing up to 90 das after the last dose of study drug. Male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of study drug.

Exclusion criteria

✕. Subject is known to be positive for HIV. HIV testing is not required.
✕. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required and subjects with serologic evidence of prior vaccination to HBV (i.e., HBs Ag, anti-HBs+ and anti-HBc-) may participate.
✕. Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
✕. Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Patients on antibiotics with controlled systemic symptoms will not be excluded.
✕. Subject has uncontrolled diabetes
✕. Subject has had a recent major hemorrhage or has a bleeding diathesis associated with a high risk of bleeding
✕. Pregnant and breastfeeding females.
✕. Subject has a history of other malignancies prior to study entry, except for:

What they're measuring

Recommended Dose

Timeframe: Start of study to end of study, for up to four years

Overall Response Rate

Timeframe: Study start date to study end date, or death, whichever comes first, up to 4 years.

Trial details

NCT IDNCT03564873

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-07

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