Expanded Access for CC-486

Celgene

Status

Conditions: Acute Myelogenous Leukemia (AML)

Treatments: Drug: CC-486

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03723135

CC-486

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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