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NCT03723135 Clinical Trial

Expanded Access for CC-486

Acute Myelogenous Leukemia (AML) Clinical Trial

Official title:
Expanded Access for CC-486

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT03723135
Other study ID # CC-486
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date September 2020
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CC-486
Oral azacitidine administered as directed by treating physician.

Locations
Country Name City State
United States Celgene Summit New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

United States, 

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