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A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)


Phase 3
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

Thank you

Trial Information

A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)


Comparison/Control Interventions offered the physician three options:

- Best supportive care (BSC) alone,

- Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or

- Standard chemotherapy administered for induction as a continuous intravenous infusion
of cytarabine over 7 days plus an anthracycline (daunorubicin, idarubicin, or
mitoxantrone) on Days 1, 2, and 3; and, for those eligible, 1 or 2 consolidation cycles
administered as continuous intravenous infusions of cytarabine for 3 to 7 days with the
same anthracycline that was used at induction on Days 1 and 2 (each cycle between 28 to
70 days from the start of the previous cycle).

All three options included best supportive care. Neither the experimental group
(azacitidine) nor any of the comparison/control options allowed use of erythropoietin.

Duration of Intervention: Patients will be treated until death, withdrawal, unacceptable
toxicity or conclusion of the study.


Inclusion Criteria:



- Have a diagnosis of refractory anemia with excess blasts or refractory anemia with
excess blasts in transformation according to the French-American-British
classification system for myelodysplastic syndromes (MDS) and a relatively high risk
of acute myeloid leukemia (AML) transformation, with an International Prognostic
Scoring System score of INT-2 or High.

- Be 18 years of age or older

- Have a life expectancy of at least 3 months

- Be unlikely to proceed to bone marrow or stem cell transplantation therapy following
remission

- Have serum bilirubin levels less than or equal to 1.5 times the upper limit of normal
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 times the upper limit of normal (unless these are considered to be related to
transfusion-induced secondary hemosiderosis)

- Have serum creatinine levels less than or equal to 1.5 times the upper limit of
normal

Exclusion Criteria:

- Secondary myelodysplastic syndromes (MDS)

- Prior treatment with azacitidine;

- Prior history of acute myeloid leukemia (AML);

- Malignant disease diagnosed within prior 12 months;

- Metastatic disease;

- Hepatic tumors;

- Radiation, chemotherapy, cytotoxic therapy for non-MDS conditions within prior 12
months;

- Prior transplantation or cytotoxic therapy to treat MDS;

- Serious medical illness likely to limit survival to 12 months or less;

- Treatment with erythropoietin or myeloid growth factors during prior 21 days or
androgenic hormones during prior 13 days;

- Active HIV, viral hepatitis type B or C;

- Treatment with investigational drugs during prior 30 days;

- Within the 28-day screening period, documented red cell folate deficiency, as
evidenced by red blood cell folate (not serum folate) or vitamin B12 deficiency

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Kaplan-Meier Estimates for Median Time to Death From Any Cause

Outcome Description:

Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.

Outcome Time Frame:

Day 1 (randomization) to 42 months

Safety Issue:

No

Principal Investigator

CL Beach

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

AZA PH GL 2003 CL 001

NCT ID:

NCT00071799

Start Date:

November 2003

Completion Date:

July 2007

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Washington University School of MedicineSaint Louis, Missouri  63110
Oregon Cancer CenterPortland, Oregon  97201-3098
Mount Sinai Medical CenterNew York, New York  10029
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
Froedtert Memorial Lutheran HospitalMilwaukee, Wisconsin  53226
Case Western Reserve UniversityCleveland, Ohio  44106
University of Alabama School of MedicineBirmingham, Alabama  35294