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

No results posted yet for this study

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

Cytarabine

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835729 on ClinicalTrials.gov