NCT03723135Approved For MarketingNot Applicable
Expanded Access for CC-486
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Approved For Marketing
- Sponsor
- Celgene
- Locations
- 1
Study Overview
Brief Summary
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.
Study Design
- Study Type
- Expanded Access
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Study Sites (1)
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