Back to resultsExpanded Access for CC-486
Primary Purpose
Acute Myelogenous Leukemia (AML)
Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
CC-486
Sponsored by
About this trial
This is an expanded access trial for Acute Myelogenous Leukemia (AML) focused on measuring Expanded Access, Compassionate Use
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
Sites / Locations
- Celgene
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03723135
Brief Title
Expanded Access for CC-486
Official Title
Expanded Access for CC-486
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
5. Study Description
Brief Summary
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia (AML)
Keywords
Expanded Access, Compassionate Use
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CC-486
Other Intervention Name(s)
Oral Azacitidine
Intervention Description
Oral azacitidine administered as directed by treating physician.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
Celgene
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Expanded Access for CC-486
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