A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia
a study on Leukemia Acute Myeloid Leukemia
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedestimated completion
Description
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).
Official Title
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
Details
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.
Keywords
Leukemia, Myeloid, Acute, CC-90009, Venetoclax, Azacitidine, Gilteritinib, Hematologic cancers, Leukemia, Acute myeloid leukemia, AML, Myeloid Leukemia
Eligibility
You can join if…
Open to people ages 18 years and up
- 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 109/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.
You CAN'T join 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:
- 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.
- 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.
Locations
- University of California, San Francisco
accepting new patients
San Francisco California 94143-0324 United States - University Of California, San Francisco
accepting new patients
San Francisco California 94143-0324 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Celgene
- Links
- BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls
- ID
- NCT04336982
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 43 study participants
- Last Updated