A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT02835729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2020-06-04
Summary
The purpose of this study is to characterize the regimen limiting toxicities (RLT) and recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving remission induction chemotherapy with cytarabine and idarubicin.
Conditions
Interventions
- DRUG
-
Idarubicin
Chemotherapy
- DRUG
-
Chemotherapy
- DRUG
-
Indoximod Freebase
IDO pathway inhibitor
- DRUG
-
Indoximod HCL F1
IDO pathway inhibitor
- DRUG
-
Indoximod HCL F2
IDO pathway inhibitor
Sponsors & Collaborators
-
NewLink Genetics Corporation
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2019-10-25
- Completion
- 2019-12-27
Countries
- United States
Study Locations
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