Study on the Safety and Effectiveness of Debio 1562M for Treating Acute Myeloid Leukemia (AML)

Inclusion Criteria

• Have relapsed or refractory Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that hasn't responded to standard treatments.
• Be in good general health with an ECOG performance status of 0 to 2.
• Any previous treatment side effects must be mild or resolved.
• Can have had a bone marrow transplant, but it must have been over 120 days ago, with no active graft versus host disease and no need for immunosuppressive drugs.
• Have good kidney and liver function as shown by specific blood tests.

Exclusion Criteria

• Have previously been treated with drugs targeting CD37.
• Have an active infection like hepatitis B or C, HIV, or any other serious infection.
• Have significant heart problems or diseases affecting the heart and lungs.
• Have other cancers, unless they are in remission and treatment was completed over 6 months ago.
• Have active leukemia in the central nervous system.
• Have severe nerve damage.
• Have allergies to Debio 1562M or its ingredients.
• Have received any leukemia treatment within 14 days before starting the trial.
• Have had major surgery within 4 weeks before starting the trial.
• Be pregnant or breastfeeding.