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

Phase 2
18 Years
Open (Enrolling)
Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome

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Trial Information

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

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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Ghulam J Mufti, MB, DM, FRCP, FRCPath

Investigator Role:

Principal Investigator

Investigator Affiliation:

King's College London


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

September 2010

Completion Date:

September 2013

Related Keywords:

  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute