Clin2
NCT04774393Possibly a fitRecruiting

Study for AML after it returns or resists treatment

Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia

Treatments studied

Part of Blood & lymphatic, Cancer clinical trials.

This Phase 1/2 trial tests a combination of medicines (decitabine/cedazuridine, venetoclax, and ivosidenib or enasidenib) in people with acute myeloid leukemia (AML) that has come back or hasn’t responded. It may help control the leukemia by targeting cancer cells and specific genetic changes in the leukemia.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1/Phase 2
Enrollment
84 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have AML that is relapsed (came back) or refractory (didn’t respond), or you have a myeloid-related mixed/biphenotypic AML, including some outside-the-bone-marrow cases
  • You are age 18 or older, and you either have relapsed/refractory AML or are newly diagnosed and not able to receive intensive chemotherapy
  • Your leukemia must have an IDH1 or IDH2 gene mutation (a specific genetic change)
  • Your overall health must allow study treatment (ECOG performance status is 2 or less, if you have a 2–3 score you may still qualify only under the “not eligible for intensive chemo” rules)
  • You must meet blood, liver, and kidney lab limits (kidney and liver numbers must be within allowed ranges unless changes are clearly caused by leukemia or specific exceptions apply)
  • You must not have certain exclusions like acute promyelocytic leukemia (FAB M3), active severe infections, uncontrolled serious medical/mental health problems, or HIV/hepatitis B or C

View the official record on ClinicalTrials.gov

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