Acute Myelogenous Leukemia (AML)NCT03723135
Expanded Access for CC-486
A study testing CC-486 in people with Acute Myelogenous Leukemia (AML), run by Celgene at 1 site in United States.
Trial summary
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia (AML)
- What is being tested?
- CC-486
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.
- Conditions
- Acute Myelogenous Leukemia (AML)
- Being tested
- CC-486
- Keywords
- Expanded Access, Compassionate Use
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-486Drug
Also called Oral Azacitidine
Oral azacitidine administered as directed by treating physician.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723135
- Sponsor's protocol ID
- CC-486
- Status last verified
- Sep 2020
- First submitted
- 25 Oct 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access for CC-486
- ClinicalTrials.gov ID
- NCT03723135
- Acronym / sponsor ID
- CC-486
- Conditions
- Acute Myelogenous Leukemia (AML)
- Keywords
- Expanded Access, Compassionate Use
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-486Also: Oral AzacitidineOral azacitidine administered as directed by treating physician. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CC-486 in people with Acute Myelogenous Leukemia (AML), run by Celgene at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.