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A Multicenter, Randomized, Open-Label Study Comparing Three Alternative Dosing Regimens of Subcutaneous Azacitidine Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes

Phase 2
18 Years
Not Enrolling
Myelodysplastic Syndromes

Thank you

Trial Information

A Multicenter, Randomized, Open-Label Study Comparing Three Alternative Dosing Regimens of Subcutaneous Azacitidine Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes

Comparison/Control Interventions: The comparison is azacitidine at different doses and

Duration of Intervention: Treatment lasted for a maximum of 18 cycles, which is up to 24

Inclusion Criteria:

- Diagnosis of refractory anemia, refractory anemia with ringed sideroblasts and at
least one of the following: a)Anemia with hemoglobin <110g/L and requires at least 1
unit packed red blood cell transfusions every 28 days; b)Thrombocytopenia with
platelet counts <100 x 10^9/L; or c)Neutropenia with absolute neutrophil count <1.5 x

- OR, Refractory anemia with excess blasts or refractory anemia with excess blast in
transformation, according to the French-American-British classification system for

- At least 18 years of age.

- Have a life expectancy of >7 months.

- Unlikely to proceed to bone marrow or stem cell transplantation therapy following

- Have serum bilirubin levels less than or equal to 1.5 times the upper limit of the
normal (ULN) range for the laboratory.

- Have serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum
glutamic-pyruvic transaminase (alanine aminotransferase) levels less than or equal to
2 x ULN.

- Have serum creatinine levels less than or equal to 1.5 x ULN.

Exclusion Criteria:

- Secondary MDS.

- Prior treatment with azacitidine.

- Any prior history of Acute Myeloid Leukemia (AML).

- Malignant or metastatic disease within the previous 12 months.

- Uncorrected red cell folate deficiency or vitamin B12 deficiency.

- Hepatic tumors.

- Radiation, chemotherapy, or cytotoxic therapy for non-MDS conditions in the previous
12 months.

- Known or suspected hypersensitivity to azacitidine or mannitol.

- Prior transplantation or cytotoxic therapy to treat MDS. Prior use of Revlimid and
Thalomid allowed after 30 day washout.

- Serious medical illness likely to limit survival to less than or equal to 7 months.

- Treatment with androgenic hormones during the previous 14 days

- Active viral infection with known human immunodeficiency virus or vial hepatitis Type
B or C.

- Treatment with other investigational drugs with the previous 30 days.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.

Outcome Description:

Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD). Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment (see Population Descrip)

Outcome Time Frame:

Day 1 (randomization) to 6 months

Safety Issue:


Principal Investigator

CL Beach

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:

AZA PH US 2004 CL 003



Start Date:

January 2005

Completion Date:

August 2008

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Preleukemia



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