Expanded Access for CC-486

Sponsor
Celgene (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT03723135
Collaborator
(none)
1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access for CC-486

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    -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.

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Celgene Summit New Jersey United States 07901

    Sponsors and Collaborators

    • Celgene

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT03723135
    Other Study ID Numbers:
    • CC-486
    First Posted:
    Oct 29, 2018
    Last Update Posted:
    Sep 18, 2020
    Last Verified:
    Sep 1, 2020
    Keywords provided by Celgene
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 18, 2020