Acute Myeloid Leukemia Clinical Trial

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

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 leukemia (AML).

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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.

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Eligibility Criteria

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):

Part A: Newly diagnosed AML with poor/adverse risk genetic abnormalities and is ≥ 75 years of age or intensive chemotherapy ineligible OR
Part A: Refractory AML 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 ≥ 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 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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

43

Study ID:

NCT04336982

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 14 Locations for this study

See Locations Near You

University of California, San Francisco
San Francisco California, 94143, United States
University Of California, San Francisco
San Francisco California, 94143, United States More Info
Catherine Smith, Site 104
Contact
Yale New Haven Hospital
New Haven Connecticut, 06510, United States
Yale New Haven Hospital
New Haven Connecticut, 06510, United States More Info
Amer Zeidan, Site 107
Contact
203-737-7078
Dana-Farber/Mass General Brigham Cancer Care, Inc
Boston Massachusetts, 02115, United States
Dana-Farber/Mass General Brigham Cancer Care, Inc
Boston Massachusetts, 02115, United States More Info
Daniel DeAngelo, Site 103
Contact
617-632-3712
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Washington University School Of Medicine
Saint Louis Missouri, 63110, United States More Info
Geoffrey Uy, Site 101
Contact
314-454-8304
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Jaime Koprivnikar, Site 108
Contact
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Courtney DiNardo, Site 105
Contact
713-792-0319
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Local Institution - 202
Edmonton Alberta, T6G 2, Canada More Info
Site 202
Contact
University of Alberta
Edmonton Alberta, T6G 2, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Hopital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada
Institut Paoli-Calmettes
Marseille , 13273, France
Local Institution - 402
Marseille , 13273, France More Info
Site 402
Contact
Hopital Haut Leveque
Pessac Cedex , 33604, France
Local Institution - 401
Pessac Cedex , 33604, France More Info
Site 401
Contact
Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
Toulouse Cedex 9 , 31059, France
Local Institution - 404
Toulouse Cedex 9 , 31059, France More Info
Site 404
Contact
John Radcliffe Hospital
Oxford , OX3 9, United Kingdom
Local Institution - 301
Oxford , OX3 9, United Kingdom More Info
Site 301
Contact

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

43

Study ID:

NCT04336982

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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