Myelodysplastic SyndromePhase 2NCT00044382
Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
A Phase 2 study testing CC-5013 in people with Myelodysplastic Syndrome, run by Celgene at 1 site in United States.
Trial summary
To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- CC-5013
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2002to 30 Jan 2007
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
- Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration.
- Baseline mean hemoglobin < 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline.
- More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion.
- Women must not be pregnant or lactating
- No use of another experimental study drug within 30 dy\ays of baseline
- Understand and sign written informed consent
- Able to adhere to study visit schedule, understand and comply with other protocol requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .
- Conditions
- Myelodysplastic Syndrome
- Being tested
- CC-5013
- Keywords
- Revimid, CC5013, CC-5013
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-5013Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2002 (estimated)
- Study start1 Feb 2002
- Primary completion1 Jan 2007
- Study completion30 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromeStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044382
- Sponsor's protocol ID
- CC-5013-MDS-501-001
- Status last verified
- Nov 2019
- First submitted
- 27 Aug 2002
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
List A, Kurtin S, Roe DJ, Buresh A, Mahadevan D, Fuchs D, Rimsza L, Heaton R, Knight R, Zeldis JB. Efficacy of lenalidomide in myelodysplastic syndromes. N Engl J Med. 2005 Feb 10;352(6):549-57. doi: 10.1056/NEJMoa041668.
PubMed 15703420
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT00044382
- Acronym / sponsor ID
- CC-5013-MDS-501-001
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Revimid, CC5013, CC-5013
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2002 (actual)
- Primary completion
- 1 Jan 2007 (actual)
- Study completion
- 30 Jan 2007 (actual)
- First posted
- 29 Aug 2002 (estimated)
- 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.
To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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-5013 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Background: PubMed 15703420List A, Kurtin S, Roe DJ, Buresh A, Mahadevan D, Fuchs D, Rimsza L, Heaton R, Knight R, Zeldis JB. Efficacy of lenalidomide in myelodysplastic syndromes. N Engl J Med. 2005 Feb 10;352(6):549-57. doi: 10.1056/NEJMoa041668.
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Myelodysplastic Syndromes
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 Phase 2 study testing CC-5013 in people with Myelodysplastic Syndrome, 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?
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: finished, as of the sponsor's last update on 8 Nov 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT00044382, which also lists 1 linked publication.
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 8 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.