A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

Stopped early · Phase 1

Conditions studied: Leukemia, Myeloid, Acute

In brief

CC-90009-AML-002 is an exploratory Phase 1b, open-label, multi-arm trial to evaluate the safety and efficacy of CC-90009 in combination with anti-leukemia agents in participants with acute myeloid leukemia (AML).

Key facts

Study ID

NCT04336982

Run by

Celgene

People needed

22

Starts

2020-08-05

Expected to finish

2024-04-05

Last updated by the study team

2024-05-31

Who can join

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

You may qualify if…

• Adult subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Arm A (CC-90009 + venetoclax/azacitidine):
• Part A: Newly diagnosed AML with poor/adverse risk genetic abnormalities and is either ≥ 75 years of age or is ineligible for intensive chemotherapy OR
• Part A: Primary Refractory AML, or AML in first relapse, and is ≥ 18 years of age
• Part B: Newly diagnosed AML and is ≥ 75 years of age or intensive chemotherapy ineligible
• Arm B (CC-90009 + gilteritinib):
• Subject is ≥ 18 years of age.
• Fms-like tyrosine kinase 3 (FLT3) mutation positive.
• Gilteritinib treatment naïve
• Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
• Subject must have the following screening laboratory values:
• Total White Blood Cell count (WBC) < 25 x 10\^9/L prior to study treatments. Treatment with hydroxyurea to achieve this level is allowed.
• Selected electrolytes within normal limits or correctable with supplements.
• Participant must have adequate liver function as demonstrated by: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) and bilirubin ≤ 1.5 x ULN
• Participant has adequate renal function as demonstrated by an estimated serum creatinine clearance of ≥ 30 mL/min.
• Agree to follow the CC-90009 Pregnancy Prevention Plan (PPP) and combination agents' requirements.

You may not qualify if…

• Subject with acute promyelocytic leukemia (APL)
• Subject has received systemic anticancer therapy (including investigational therapy) or radiotherapy < 28 days or 5 half-lives, whichever is shorter, prior to the start of study treatment
• Patients with prior autologous hematopoietic stem cell transplant (HSCT) who, in the investigator's judgment, have not fully recovered from the effects of the last transplant (eg, transplant related side effects)
• Prior allogeneic HSCT with either standard or reduced intensity conditioning ≤ 6 months prior to dosing
• Subject on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of topical steroids for ongoing skin or ocular GVHD is permitted
• Subject has persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to < Grade 2
• Subject has or is suspected of having central nervous system (CNS) leukemia. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening.
• Disorders or conditions disrupting normal calcium homeostasis or preventing calcium supplementation.
• Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
• Left ventricular ejection fraction (LVEF) < 45% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO).
• Complete left bundle branch or bifascicular block.
• Congenital long QT syndrome.
• Persistent or clinically meaningful ventricular arrhythmias.
• QTcF ≥ 470 ms (Arm A) or > 450 ms (Arm B) on Screening electrocardiogram (ECG)
• Unstable angina pectoris or myocardial infarction ≤ 6 months prior to starting study treatments or unstable arrhythmia.
• Cardiovascular disability status of New York Heart Association Class ≥2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.
• Subject is a pregnant or lactating female
• Additional exclusion criteria based on combination agent:
• a. For Combination Arm A (venetoclax/azacitidine):
• Received strong or moderate CYP3A inhibitors or inducers or P-gp inhibitors within 7 days prior to initiation of first venetoclax dose.
• Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or Star fruit within 3 days prior to first venetoclax dose through last dose of venetoclax.
• Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to C1D1.
• a. Acute symptoms must have resolved and based on investigator assessment in consultation with the medical monitor, there are no sequelae that would place the participant at a higher risk of receiving study treatment.
• Previous SARS-CoV-2 vaccine within 14 days of C1D1.

Where it is running

• Local Institution - 104 — San Francisco, California, United States
• Local Institution - 107 — New Haven, Connecticut, United States
• Local Institution - 103 — Boston, Massachusetts, United States
• Local Institution - 101 — St Louis, Missouri, United States
• Local Institution - 108 — Hackensack, New Jersey, United States
• Local Institution - 105 — Houston, Texas, United States
• Local Institution - 102 — Seattle, Washington, United States
• Local Institution - UNK3 — Yvoir, Belgium
• Local Institution - 202 — Edmonton, Alberta, Canada
• Local Institution - 201 — Toronto, Ontario, Canada
• Local Institution - 402 — Marseille, France
• Local Institution - 401 — Pessac, France
• Local Institution - 404 — Toulouse, France
• Local Institution - 301 — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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