Expanded Access for CC-486
Sponsor: Celgene
ClinicalTrials ID:NCT03723135
This expanded access program provides CC-486, an oral azacitidine, to adult AML patients in first complete remission or with incomplete blood count recovery post-induction therapy. Excludes those awaiting or post-bone marrow transplant, with relapsed/refractory AML, pregnant/breastfeeding women, or eligible for disease-specific trials.
Patient Parameters
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Program Overview
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.
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
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