Official Title
Expanded Access for CC-486
Brief Summary

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

Approved for marketing
Individual Patients
Acute Myelogenous Leukemia (AML)

Drug: CC-486
Oral azacitidine administered as directed by treating physician.
Other Name: Oral Azacitidine

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Celgene
Summit, New Jersey, 07901

NCT Number
Keywords
Expanded Access
Compassionate Use
MeSH Terms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Intervention Name
CC-486