Expanded Access for CC-486
- Conditions
- Acute Myelogenous Leukemia (AML)
- Registration Number
- NCT03723135
- Lead Sponsor
- Celgene
- Brief Summary
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Celgene
🇺🇸Summit, New Jersey, United States