NCT03723135

Brief Summary

This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.

Trial Health

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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

September 18, 2020

Status Verified

September 1, 2020

First QC Date

October 25, 2018

Last Update Submit

September 16, 2020

Conditions

Acute Myelogenous Leukemia (AML)

Keywords

Expanded AccessCompassionate Use

Interventions

CC-486DRUG

Oral azacitidine administered as directed by treating physician.

Also known as: Oral Azacitidine

Eligibility Criteria

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

You may qualify if:

  • Adult patients with documented acute myelogenous leukemia (AML) in their first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, who seek treatment with CC-486 as monotherapy to maintain their CR or CRi.

You may not qualify if:

  • Patients with AML in CR/CRi who plan to proceed to or are waiting for a bone marrow transplant
  • Patients who have received a bone marrow transplant for the treatment of AML
  • Treatment of AML patients with relapse or refractory disease
  • Pregnant or breast-feeding females
  • Patient meets enrollment criteria and can participate in a disease-specific clinical trial

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

cc-486Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

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

September 18, 2020

Record last verified: 2020-09

Locations

US(1)