A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)

Stopped early · Phase 1

Conditions studied: Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID

NCT02641002

Run by

Celgene

People needed

28

Starts

2016-03-01

Expected to finish

2018-07-18

Last updated by the study team

2018-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Prior autologous hematopoietic stem cell transplant ≤ 3 months.
• Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or reduced intensity conditioning ≤ 6 months.
• Systemic immunosuppressive therapy post HSCT or with clinically significant graft-versus-host disease (GVHD).
• Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks whichever is shorter.
• Major surgery ≤ 2 weeks and recovered from any clinically significant effects of recent surgery.
• Pregnant or nursing females.
• Known HIV infection.
• Known chronic hepatitis B or C (HBV/HCV) infection.
• Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
• History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
• History of concurrent second cancers requiring active, ongoing systemic treatment.
• Subjects for whom potentially curative anticancer therapy is available.

Where it is running

• Mayo Clinic Phoenix — Phoenix, Arizona, United States
• UCLA Division of Hematology Oncology — Los Angeles, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• University of Chicago — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.