Status:
TERMINATED
A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia
Lead Sponsor:
Celgene
Collaborating Sponsors:
AbbVie
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 leu...
Detailed 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-leuk...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04336982
Start Date
August 5 2020
End Date
April 5 2024
Last Update
May 31 2024
Active Locations (14)
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1
Local Institution - 104
San Francisco, California, United States, 94143-0324
2
Local Institution - 107
New Haven, Connecticut, United States, 06510
3
Local Institution - 103
Boston, Massachusetts, United States, 02115
4
Local Institution - 101
St Louis, Missouri, United States, 63110