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A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Trial Status: administratively complete
Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion
(Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in
subjects with relapsed and/or primary refractory AML and high-risk MDS. The study will
explore escalating doses of CC-90002 using a 3 + 3 dose escalation design in Part A,
followed by dose expansion in Part B.
The primary objective is to determine the safety and tolerability of CC-90002 and also to
define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the
recommended Phase 2 dose (RP2D) of CC-90002.
Inclusion Criteria
Men and women ≥ 18 years of age, at the time of signing the informed consent form (ICF).
Relapsed and/or primary refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) with subtype refractory anemia with excess blasts (RAEB)-2 defined as high or very high-risk that is recurrent or refractory, or the patient is intolerant to established therapy.
Subject consents to hospitalization for first (Cycle 1 Day 1) dose of CC-90002 and for 72 hours after.
Subject consents to serial bone marrow aspiration and biopsies as specified.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
Eligible study subjects must exhibit acceptable liver, renal, and coagulation function as assessed by laboratory tests.
Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and for up to 8 weeks following the last dose of CC 90002.
Exclusion Criteria
Active central nervous system (CNS) leukemia or known CNS leukemia.
Immediately life-threatening, severe complications of leukemia.
Impaired cardiac function or clinically significant cardiac diseases.
