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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01133886
Other study ID # DEC-MDS
Secondary ID
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


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
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