Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure (DEC-MDS)
This study is currently recruiting participants.
Verified September 2010 by King's College London
Sponsor:
King's College London
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
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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:
- 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).
Exclusion Criteria:
- 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.
Contacts and Locations
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 May 23, 2013