Acute Myeloid LeukemiaPhase 2DEC-MDSNCT01133886
Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure
A Phase 2 study testing Decitabine in people with Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, run by King's College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the response rate at 6 months in Myelodysplastic Syndrome (MDS) patients, Chronic Myelomonocytic Leukaemia (CMML-2) patients, and Acute Myeloid Leukaemia (AML) patients with up to 30% bone marrow blasts, treated with low-dose decitabine who have previously failed therapy with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Sep 2013
- 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
Who may be able to join
- Written signed informed consent.
- ≥18 years of age.
- Diagnosed MDS with 5% or more marrow blasts and IPSS risk intermediate 2 or high risk; or chronic myelomonocytic leukemia (CMML-2); or AML with 20-30% bone marrow blasts.
- Patients who have failed therapy with azacitidine.
- Performance status 0-2 (ECOG scale).
- Adequate hepatic (bilirubin < 1.5 X ULN or AST< 2.5 X ULN) and renal functions (creatinine <1.5 X ULN).
Who cannot join
- Nursing and pregnant females.
- Females of childbearing potential and males not willing to practice an effective method of contraception whilst receiving decitabine and for 2 months after the last infusion.
- Patients with previous malignancy or concurrent malignancy.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
- Ongoing oral corticosteroids are not permitted. However, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
- Patients who have received any investigational agent within the 30 days preceding the first dose of study drug.
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- Patients who have received prior intensive combination chemotherapy or high-dose cytarabine (>/= 1g/m*2 per dose). (Prior biologic therapies, targeted therapies and single agent chemotherapy are allowed).
- Patients who have an active viral or bacterial infection. Note: No patient is allowed to enter the study unless infections have been fully treated and the patient has remained afebrile for 7 days without antibiotics.
- Patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.
- Patients who have previously been treated with decitabine.
- Patients who have known positive serology for HIV.
- Patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Ghulam J Mufti, MB, DM, FRCP, FRCPath, +44 (0) 20 3299 9000 ext. 3238, ghulam.mufti@kcl.ac.uk
About this study
The purpose of this study is to assess the response rate at 6 months in Myelodysplastic Syndrome (MDS) patients, Chronic Myelomonocytic Leukaemia (CMML-2) patients, and Acute Myeloid Leukaemia (AML) patients with up to 30% bone marrow blasts, treated with low-dose decitabine who have previously failed therapy with 5-azacitidine.
- Being tested
- Decitabine
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called Dacogen
Patients will receive decitabine as a 20mg/m2 one hour intravenous infusion once daily on days 1 to 5 of a 4 week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Decitabine | Experimental | Not described Receives: Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate in the efficacy-evaluable (EE) population
Measured: 6 months
Secondary outcomes (6)
Overall survival
Measured: 18 months
Time to AML progression (for MDS and CMML-2 patients only) or death
Measured: 18 months
Haematological improvement
Measured: 18 months
Transfusion requirements
Measured: 18 months
Cytogenetic response
Measured: 18 months
Treatment related toxicity
Measured: Up until one month after last IMP dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Investigators
- Ghulam J Mufti, MB, DM, FRCP, FRCPath, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133886
- Sponsor's protocol ID
- DEC-MDS
- Acronym
- DEC-MDS
- Status last verified
- Sep 2010
- First submitted
- 28 May 2010
- Last updated
- 3 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure
- ClinicalTrials.gov ID
- NCT01133886
- Acronym / sponsor ID
- DEC-MDS / DEC-MDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 31 May 2010 (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.
The purpose of this study is to assess the response rate at 6 months in Myelodysplastic Syndrome (MDS) patients, Chronic Myelomonocytic Leukaemia (CMML-2) patients, and Acute Myeloid Leukaemia (AML) patients with up to 30% bone marrow blasts, treated with low-dose decitabine who have previously failed therapy with 5-azacitidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine | Experimental | Drug: Decitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written signed informed consent.
- ≥18 years of age.
- Diagnosed MDS with 5% or more marrow blasts and IPSS risk intermediate 2 or high risk; or chronic myelomonocytic leukemia (CMML-2); or AML with 20-30% bone marrow blasts.
- Patients who have failed therapy with azacitidine.
- Performance status 0-2 (ECOG scale).
Key exclusion criteria (12 listed)
- Nursing and pregnant females.
- Females of childbearing potential and males not willing to practice an effective method of contraception whilst receiving decitabine and for 2 months after the last infusion.
- Patients with previous malignancy or concurrent malignancy.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
- Ongoing oral corticosteroids are not permitted. However, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
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 |
|---|---|---|
| DecitabineAlso: DacogenPatients will receive decitabine as a 20mg/m2 one hour intravenous infusion once daily on days 1 to 5 of a 4 week cycle. | Drug | Decitabine |
Primary outcome
Overall response rate in the efficacy-evaluable (EE) population
Time frame: 6 months
6 secondary outcomes
Overall survival
Time frame: 18 months
Time to AML progression (for MDS and CMML-2 patients only) or death
Time frame: 18 months
Haematological improvement
Time frame: 18 months
Transfusion requirements
Time frame: 18 months
Cytogenetic response
Time frame: 18 months
Treatment related toxicity
Time frame: Up until one month after last IMP dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2010.
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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.
Ghulam J Mufti, MB, DM, FRCP, FRCPath principal investigator
King's College London
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 Decitabine in people with Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, run by King's College London at 1 site in United Kingdom.
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 6 inclusion and 12 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 3 Sep 2010. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghulam J Mufti, MB, DM, FRCP, FRCPath (+44 (0) 20 3299 9000 ext. 3238, ghulam.mufti@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate in the efficacy-evaluable (EE) population (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 3 Sep 2010.