An open phase 1 study for dose-finding of CC-91633 (BMS-986397) in patients with relapsed or refractory acute myeloid leukemia or relapsed or refractory high-grade myelodysplastic syndromes.

Criteri di partecipazione
Patients must meet the following essential inclusion criteria for dose escalation (Part A) and dose expansion (Part B) of the study: • Patients must be ≥ 18 years of age at the time of signing the informed consent form. • Patients must understand the ICF and have voluntarily signed it before any study-related procedures are performed. • Patients are willing and able to adhere to the study visit schedule and other protocol requirements. • Patients must have R/R AML and R/R HR-MDS according to World Health Organization (WHO) criteria, have exhausted all available therapies that could provide clinical benefit or not responded to available therapies, • They must have an ECOG score of 0 to 2. • They must have specific screening laboratory values according to the protocol. o Total white blood cell count (WBC) < 25 x 10^9/l prior to the first infusion. o Aspartate aminotransferase (AST)/serum glutamate oxaloacetate transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) ≤ 3.0 x upper limit of normal (ULN), unless this is accepted due to leukemic organ involvement; in this case, AST and ALT may be ≤ 5.0 x ULN. Uric acid ≤ 7.5 mg/dl (446 μmol/l). o Total bilirubin in serum ≤ 1.5 x ULN, unless accepted due to Gilbert's syndrome o Estimated serum creatinine clearance of ≥ 60 ml/min using the Cockcroft-Gault equation. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated. o INR < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN. • (BASEC)

Criteri di esclusione
• The presence of any of the following exclusion criteria will result in a participant not being enrolled in the study: Any condition, including active or uncontrolled infection or the presence of laboratory abnormalities, that increases the risk to the participant of participating in the study unacceptably. • Any other significant illness, laboratory abnormality, or psychiatric disorder that exposes patients to an unacceptable risk if they were to participate in the study or that would prevent patients from participating in the study. • Patients have a condition that affects their ability to interpret data from the study. • Patients with acute promyelocytic leukemia. • Patients with clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia. • Patients with immediately life-threatening severe complications of leukemias such as disseminated/uncontrolled infections, uncontrolled bleeding, and/or uncontrolled disseminated intravascular coagulation. • Patients with impaired cardiac function or clinically significant cardiac diseases • Patients who have undergone major surgery ≤ 2 weeks prior to the start of treatment with CC-91633. Patients must have recovered from all clinically significant effects of the recently performed surgery. • Pregnant or breastfeeding individuals. • Patients with known infection with human immunodeficiency virus (HIV) • Patients with known chronic active hepatitis B virus or hepatitis C virus infection. • Patients on chronic therapeutic anticoagulation (e.g., warfarin, low molecular weight heparin, factor Xa inhibitors) • Patients with another cancer requiring ongoing systemic treatment. • Patients with clinically significant diarrhea, vomiting, or malabsorption that limits the absorption of orally administered medications. • Patients with known or suspected hypersensitivity to any of the components or excipients of the study treatment or to drugs of similar classes (e.g., lenalidomide) (BASEC)