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Protocol No.1562GCCPrincipal InvestigatorEmadi, Ashkan
PhasePhase I
Age GroupAdult
TitleA Phase 1 Trial of Indoximod in Combination with Idarubicin and Cytarabine in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) [NLG-2106]
DescriptionDuring Phase 1 portion of study, Indoximod will be administered at a dose of 400 mg, 600 mg, 1000 mg or 1200 mg orally three times a day based on the dose escalation protocol.

TreatmentIndoximod + idarubicin and cytarabine
Key EligibilityInclusion Criteria
-Age ≥ 18 years
-A histologically or pathologically confirmed diagnosis of AML based on WHO classification with or without extramedullary disease except for central nervous system disease. Patients with myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN) evolving into AML who are candidates for AML induction therapy are eligible for enrollment.
-ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
-For the Phase 1 portion of the study patients must have normal organ function as defined below:
o Total bilirubin ≤ 1.5 X the institutional upper limit of normal (IULN) (except in patients with Gilbert’s Syndrome and evidence of hemolysis or leukemic infiltration of the liver and Total Bilirubin ≤ 2 X IULN)
o AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal (except if attributable to leukemic infiltration of liver and AST/ALT ≤ 4 X IULN)
o Creatinine Clearance ≥ 60 mL/min (except in patients with evidence of tumor lysis syndrome and Creatinine Clearance ≥ 45 mL/min)
-Left ventricular ejection fraction (LVEF) ≥ 50%
-Negative pregnancy test

Exclusion Criteria
-receiving any other investigational agents or immunotherapy
-prior chemotherapy for AML with the exception of hydroxyurea or leukapheresis for leukocytosis; prior hypomethylating or immunomodulatory agents for MDS are allowed
-acute promyelocytic leukemia (APL) confirmed with t(15;17) (i.e. FAB subtype M3 or M3 variant)
-history or active central nervous system (CNS) involvement with AML
-Blastic transformation of chronic myelogenous leukemia (CML)
-Previous allo-HSCT of any kind
-Hyperleukocytosis with > 50K blasts/μL. Hydroxyurea for blast count control is permitted before starting treatment and up to a maximum of 5 days after starting treatment on the study. The WBC need not reach 50K/μL to start hydroxyurea; the decision to start hydroxyurea is at the discretion of the treating physician
-Prior treatment with indoximod
-Chronic steroid dependence (should have stopped all steroid supplementation 4 weeks prior to enrollment)
-History of prior treatment with anti-CTLA4 blocking antibody or similar antibodies or PD-1 checkpoint antibodies
- Active, uncontrolled infection including known hepatitis B or C; patients with infection under active treatment and controlled with antibiotics are eligible
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that per PI’s judgment would limit compliance with study requirements
-Active autoimmune disease and chronic inflammatory conditions requiring concurrent use of any systemic immunosuppressants or steroids. Mild intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be exclusions
-History of any other active cancer diagnosis (more recently than three years prior) except for surgically resected basal cell carcinoma surgically resected DCIS of the breast
-Pregnancy
-Known HIV-infected patients
-Active gastrointestinal disease
-Unable to take medications by mouth
-History of allergic reactions attributed to any of the study drugs, compounds of similar chemical or biologic composition, or excipients with these agents
-Patients taking strong inhibitors/inducers of CYP3A4, CYP2D6 or CYP2C9
Applicable Disease SitesAcute Myeloid Leukemia
Therapies InvolvedChemotherapy (NOS)
Enzyme Inhibitors
Immunotherapy
Therapy (NOS)
Drugs InvolvedCytarabine (Cytosine Arabinoside)
Idarubicin
Indoximod
Placebo
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02835729
ContactGreenebaum Cancer Center Mohammad Imran, MS, MD Phone:410-328-2243
Pager:
Email:Mohammad.Imran@umm.edu
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