NCT03723057

Brief Summary

This is an expanded access program (EAP) for eligible participants designed to provide access to AG-221.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

First QC Date

October 25, 2018

Last Update Submit

October 23, 2019

Conditions

Acute Myeloid Leukemia

Keywords

Expanded AccessCompassionate Use

Interventions

AG-221DRUG

Oral AG-221 administered as directed by treating physician.

Also known as: CC-90007; Enasidenib; Idhifa

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celgene

Summit, New Jersey, 07901, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

enasidenib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 29, 2018

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations

US(1)