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

Who is this study for? Patients with Leukemia, Myelodysplastic Syndrome
What treatments are being studied? Decitabine
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
United Kingdom
King's College Hospital NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Ghulam J Mufti, MB, DM, FRCP, FRCPath
ghulam.mufti@kcl.ac.uk
+44 (0) 20 3299 9000
Time Frame
Start Date: 2010-09
Completion Date: 2013-09
Participants
Target number of participants: 50
Treatments
Experimental: Decitabine
Sponsors
Collaborators: King's College Hospital NHS Trust
Leads: King's College London

This content was sourced from clinicaltrials.gov

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