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

Acute Myeloid Leukemia Clinical Trial

— DEC-MDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01133886
• Other study ID #: DEC-MDS
• Status: Recruiting
• Phase: Phase 2
• First received: May 28, 2010
• Last updated: September 2, 2010
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: September 2010
• Source: King's College London
• Contact: Ghulam J Mufti, MB, DM, FRCP, FRCPath
• Phone: +44 (0) 20 3299 9000
• Email: ghulam.mufti[@]kcl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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 5-azacitidine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myeloid, Acute
• Leukemia, Myelomonocytic, Acute
• Leukemia, Myelomonocytic, Chronic
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Decitabine
Patients will receive decitabine as a 20mg/m2 one hour intravenous infusion once daily on days 1 to 5 of a 4 week cycle.

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate in the efficacy-evaluable (EE) population		6 months	No
Secondary	Overall survival		18 months	No
Secondary	Time to AML progression (for MDS and CMML-2 patients only) or death		18 months	No
Secondary	Haematological improvement		18 months	No
Secondary	Transfusion requirements		18 months	No
Secondary	Cytogenetic response		18 months	No
Secondary	Treatment related toxicity		Up until one month after last IMP dose	Yes