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

NCT01133886 | Unknown Phase 2

• 1 other identifier: DEC-MDS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• Overall response rate in the efficacy-evaluable (EE) population

  6 months

Secondary Outcomes (6)

• Overall survival

  18 months

• Time to AML progression (for MDS and CMML-2 patients only) or death

  18 months

• Haematological improvement

  18 months

• Transfusion requirements

  18 months

• Cytogenetic response

  18 months

Study Arms (1)

Decitabine

EXPERIMENTAL

Drug: Decitabine

Interventions

Decitabine DRUG

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

Also known as: Dacogen

Decitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written signed informed consent.
• ≥18 years of age.
• 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.
• Patients who have failed therapy with azacitidine.
• Performance status 0-2 (ECOG scale).
• Adequate hepatic (bilirubin \< 1.5 X ULN or AST\< 2.5 X ULN) and renal functions (creatinine \<1.5 X ULN).

You may not qualify if:

• Nursing and pregnant females.
• 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.
• Patients with previous malignancy or concurrent malignancy.
• Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
• Ongoing oral corticosteroids are not permitted. However, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
• Patients who have received any investigational agent within the 30 days preceding the first dose of study drug.
• 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).
• 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.
• Patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.
• Patients who have previously been treated with decitabine.
• Patients who have known positive serology for HIV.
• Patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.

Sponsors & Collaborators

• King's College London: lead
• King's College Hospital NHS Trust: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Chronic; Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

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

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghulam J Mufti, MB, DM, FRCP, FRCPath

CONTACT

+44 (0) 20 3299 9000; ghulam.mufti@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: May 31, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: September 3, 2010

Record last verified: 2010-09

Locations

GB (1)