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About
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).
Full description
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.
Enrollment
Sex
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Volunteers
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):
Arm B (CC-90009 + gilteritinib):
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.
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 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:
Subject is a pregnant or lactating female
Additional exclusion criteria based on combination agent:
a. For Combination Arm A (venetoclax/azacitidine):
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.
Primary purpose
Allocation
Interventional model
Masking
22 participants in 2 patient groups
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Central trial contact
BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain the NCT# and Site #
Data sourced from clinicaltrials.gov
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