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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01133886
Recruitment Status : Unknown
Verified September 2010 by King's College London.
Recruitment status was:  Recruiting
First Posted : May 31, 2010
Last Update Posted : September 3, 2010
King's College Hospital NHS Trust
Information provided by:
King's College London

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome Drug: Decitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure
Study Start Date : September 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Decitabine 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.
Other Name: Dacogen

Primary Outcome Measures :
  1. Overall response rate in the efficacy-evaluable (EE) population [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 18 months ]
  2. Time to AML progression (for MDS and CMML-2 patients only) or death [ Time Frame: 18 months ]
  3. Haematological improvement [ Time Frame: 18 months ]
  4. Transfusion requirements [ Time Frame: 18 months ]
  5. Cytogenetic response [ Time Frame: 18 months ]
  6. Treatment related toxicity [ Time Frame: Up until one month after last IMP dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01133886

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Contact: Ghulam J Mufti, MB, DM, FRCP, FRCPath +44 (0) 20 3299 9000 ext 3238

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United Kingdom
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Contact: Ghulam J Mufti, MB, DM, FRCP, FRCPath    +44 (0) 20 3299 9000 ext 3238   
Sponsors and Collaborators
King's College London
King's College Hospital NHS Trust
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Principal Investigator: Ghulam J Mufti, MB, DM, FRCP, FRCPath King's College London
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Responsible Party: Professor Ghulam Mufti, King's College London Identifier: NCT01133886    
Other Study ID Numbers: DEC-MDS
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: September 3, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myelodysplastic-Myeloproliferative Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors