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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by King's College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
King's College Hospital NHS Trust
Information provided by:
King's College London
ClinicalTrials.gov Identifier:
NCT01133886
First received: May 28, 2010
Last updated: September 2, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Myelodysplastic Syndrome
Drug: Decitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • Overall response rate in the efficacy-evaluable (EE) population [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Time to AML progression (for MDS and CMML-2 patients only) or death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Haematological improvement [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Transfusion requirements [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Cytogenetic response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Treatment related toxicity [ Time Frame: Up until one month after last IMP dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133886

Contacts
Contact: Ghulam J Mufti, MB, DM, FRCP, FRCPath +44 (0) 20 3299 9000 ext 3238 ghulam.mufti@kcl.ac.uk

Locations
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    ghulam.mufti@kcl.ac.uk   
Sponsors and Collaborators
King's College London
King's College Hospital NHS Trust
Investigators
Principal Investigator: Ghulam J Mufti, MB, DM, FRCP, FRCPath King's College London
  More Information

No publications provided

Responsible Party: Professor Ghulam Mufti, King's College London
ClinicalTrials.gov Identifier: NCT01133886     History of Changes
Other Study ID Numbers: DEC-MDS
Study First Received: May 28, 2010
Last Updated: September 2, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014