Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01133886
• Date of registration: 28/05/2010
• Primary sponsor: King's College London
• Public title: Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure DEC-MDS
• Scientific title: Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure
• Date of first enrolment: September 2010
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01133886
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United Kingdom

Contacts

• Name: Ghulam J Mufti, MB, DM, FRCP, FRCPath

• Name: Ghulam J Mufti, MB, DM, FRCP, FRCPath

• Name: Ghulam J Mufti, MB, DM, FRCP, FRCPath
• Affiliation: King's College London

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Written signed informed consent.

2. =18 years of age.

3. 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.

4. Patients who have failed therapy with azacitidine.

5. Performance status 0-2 (ECOG scale).

6. Adequate hepatic (bilirubin < 1.5 X ULN or AST< 2.5 X ULN) and renal functions
(creatinine <1.5 X ULN).

Exclusion Criteria:

1. Nursing and pregnant females.

2. 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.

3. Patients with previous malignancy or concurrent malignancy.

4. Uncontrolled intercurrent illness including, but not limited to, symptomatic
congestive heart failure and unstable angina pectoris.

5. Ongoing oral corticosteroids are not permitted. However, use of corticosteroids
(topical and inhaled) is permitted and prophylactic steroids are allowed for
transfusion reactions.

6. Patients who have received any investigational agent within the 30 days preceding the
first dose of study drug.

7. 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).

8. 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.

9. Patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.

10. Patients who have previously been treated with decitabine.

11. Patients who have known positive serology for HIV.

12. Patients with a condition that may be unable to comply with the treatment and
monitoring requirements of the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Myeloid Leukemia

Chronic Myelomonocytic Leukemia

Myelodysplastic Syndrome

Intervention(s)

Drug: Decitabine

Primary Outcome(s)

Overall response rate in the efficacy-evaluable (EE) population [Time Frame: 6 months]

Secondary Outcome(s)

Cytogenetic response [Time Frame: 18 months]

Haematological improvement [Time Frame: 18 months]

Overall survival [Time Frame: 18 months]

Time to AML progression (for MDS and CMML-2 patients only) or death [Time Frame: 18 months]

Transfusion requirements [Time Frame: 18 months]

Treatment related toxicity [Time Frame: Up until one month after last IMP dose]

Secondary ID(s)

DEC-MDS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

King's College Hospital NHS Trust