Expanded Access for CC-486

NCT ID: NCT03723135

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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

Detailed Description

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Conditions

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Acute Myelogenous Leukemia (AML)

Interventions

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CC-486

Oral azacitidine administered as directed by treating physician.

Intervention Type DRUG

Other Intervention Names

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Oral Azacitidine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celgene

Summit, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CC-486

Identifier Type: -

Identifier Source: org_study_id

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