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An Open-label, Multi-center, Phase IIIb Study for Decitabine in Patients With Myelodysplastic Syndrome (MDS)

Phase 3
18 Years
Open (Enrolling)
Myelodysplastic Syndrome

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Trial Information

An Open-label, Multi-center, Phase IIIb Study for Decitabine in Patients With Myelodysplastic Syndrome (MDS)

This is a prospective (look forward using periodic observations collected predominantly
following patient enrollment), open-label (all people involved in the study know the
identity of the assigned drug), Phase IIIb study to evaluate the efficacy and safety of
decitabine in the treatment of myelodysplastic syndrome (MDS). Patients are randomized
(study drug assigned by chance) in 1:1 ratio to receive treatment with decitabine either
3-day or 5-day course of therapy. When a minimum of 30 patients are reached for 3-day course
of therapy, the rest of the patients will all be enrolled into 5-day course of therapy. Each
patient in the study treated for a minimum of 4 cycles; however, a complete or partial
response may take longer than 4 cycles. The entire study duration for each patient will be
approximately two years. Safety will be evaluated for each patient by monitoring of adverse
events, physical examinations, vital signs measurements, electrocardiogram, hematology and
clinical chemistry testing.

Inclusion Criteria:

- Must have diagnosed with Myelodysplastic Syndrome (MDS) denovo (previously not
present) or secondary as per the classification of French-American-British (FAB) and
International Prognostic Scoring System (IPSS) greater than or eaul to 0.5 as
determined by complete blood count (CBC), bone marrow assessment and bone marrow

- Must have an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2

- Must have adequate hepatic and renal function as measured by the aspartate
transaminase (AST), alanine transaminase (ALT), total bilirubin and serum creatinine,

- Must have recovered from all toxic effects of prior therapy and not received any
chemotherapy for a minimum of 4 weeks (6 weeks if the patient has been treated with a
nitrosoureas) prior to the first dose of study drug - Woman must be postmenopausal,
or surgically sterile, or abstinent, or, if sexually active, be practicing an
effective method of birth control (eg, oral contraceptives, contraceptive injections,
intrauterine device, double-barrier method, contraceptive patch, male partner

Exclusion Criteria:

- Must not have a diagnosis of acute myeloid leukemia (greater than 30% bone marrow
blasts) - Must not have received radiotherapy within 14 days before the first dose of
study drug - Must not have any other prior cancer, other than superficial bladder
cancer, basal cell skin and cervical cancer - Must not have associated autoimmune
hemolytic anemia or immune thrombocytopenia and inaspirable bone marrow - Must not
have a mental illness or any other condition (eg, uncontrolled cardiac or pulmonary
disease, diabetes), that could prevent full cooperation with the study requirements.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (ORR)

Outcome Description:

The ORR is measured by complete response (CR)+ marrow CR (mCR)+partial response (PR) as per International working group for MDS (IWG 2006) criteria. End of treatment is defined as 30 days after last dose of study drug.

Outcome Time Frame:

From the date of randomization to the date of disease progression or death, whatever comes first, assessed up to 2 years

Safety Issue:


Principal Investigator

Xian-Janssen Pharmaceutical Ltd Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Xian-Janssen Pharmaceutical Ltd.


China: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

April 2013

Related Keywords:

  • Myelodysplastic Syndrome
  • Myelodysplastic Syndrome
  • Dacogen
  • Oncology
  • Decitabine
  • Bone marrow disorders
  • Myelodysplastic Syndromes
  • Preleukemia