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Expanded Access for CC-486

Expanded Access for CC-486

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03723135
Enrollment
Unknown
Registered
2018-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2020-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myelogenous Leukemia (AML)

Keywords

Expanded Access, Compassionate Use

Brief summary

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

Interventions

DRUGCC-486

Oral azacitidine administered as directed by treating physician.

Sponsors

Celgene
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026