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

Trial Status: Active

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 subjects with acute myeloid leukemia (AML).

Inclusion Criteria

  • Adult subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  • Arm A (CC-90009 + venetoclax/azacitidine):
  • Newly diagnosed AML and is ≥ 75 years of age or intensive chemotherapy ineligible OR
  • Refractory AML and is ≥ 18 years of age
  • Arm B (CC-90009 + gilteritinib):
  • Subject is ≥ 18 years of age.
  • FLT3-ITD positive relapsed or refractory AML.
  • 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 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 ≥ 60 mL/min using the Cockcroft-Gault equation.
  • Agree to follow the CC-90009 Pregnancy Prevention Plan (PPP) and combination agents' requirements.

Exclusion Criteria

  • 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
  • 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. suspected during screening.
  • Subject is a pregnant or lactating female
  • Additional exclusion criteria based on combination agent:
  • 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.

California

San Francisco
UCSF Medical Center-Parnassus
Status: ACTIVE
Contact: UCSF
Phone: 877-827-3222

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: IN_REVIEW

Study CC-90009-AML-002 is an open-label, multi-arm, parallel multi-cohort, multicenter, Phase

1b study to determine the safety, tolerability, PK, and efficacy of CC 90009 in combination

with anti-leukemia agents used for the treatment of AML. CC 90009 will be given as a

combination therapy to subjects with newly diagnosed (ND) or relapsed or refractory (R/R)

AML.

The dose and schedule finding part (Part A) of the study will evaluate the safety, PK and PD

data, and preliminary efficacy information and determine the Part B dose and schedule for

each arm.

The expansion part (Part B) of the study will further evaluate the safety and efficacy of the

CC-90009 containing combination at or below the maximum tolerated dose (MTD) in the selected

cohorts in order to determine the recommended Phase 2 dose (RP2D) for subjects with AML.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Celgene

  • Primary ID CC-90009-AML-002
  • Secondary IDs NCI-2020-03281, U1111-1247-5619, 2019-001681-15
  • Clinicaltrials.gov ID NCT04336982