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A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2'Deoxycytidine) Versus Supportive Care in Adults With Advanced-stage Myelodysplastic Syndrome


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

Thank you

Trial Information

A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2'Deoxycytidine) Versus Supportive Care in Adults With Advanced-stage Myelodysplastic Syndrome


This experimental (investigational) study is intended to answer the question of whether
decitabine is any better than supportive care alone in delaying progression (worsening) of
the disease, prolonging survival or improving the overall quality of life for MDS patients
who are not candidates for bone marrow transplant (BMT).

Inclusion Criteria


Inclusion:

- MDS (de novo or secondary) fitting any of the recognized French-American-British,
FAB, classifications or chronic myelomonocytic leukemia (CMML) with WBC < 12,000/mm3,
AND International Prognostic Scoring System (IPSS) >/= 0.5 as determined by CBC, bone
marrow assessment and bone marrow cytogenetics within 30 days of randomization

- 18 years or older

- Female patients of child-bearing potential must have a negative serum hCG within 24
hours prior to randomization, must practice a medically approved method of birth
control for the past 30 days, and agree to continue this practice for the trial
duration and must not be breast-feeding

- ECOG or WHO performance status of 0-2

- Written informed consent

- Normal renal and hepatic function (creatinine SGPT
Exclusion:

- Acute Myeloid Leukemia (AML) (>/=30% bone marrow blasts) or other progressive
malignant disease

- Patients must have recovered from the toxic effects of prior therapy and must be off
all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a
minimum of six weeks for prior nitrosoureas and bone marrow transplantation)

- Ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or
other agents used to treat MDS within 7 days of study initiation.

- Administration of any investigational agent within the 30 days preceding study
initiation.

- Uncontrolled cardiac disease or congestive heart failure

- Uncontrolled restrictive or obstructive pulmonary disease

- Active viral or bacterial infection

- Superimposed autoimmune hemolytic anemia or thrombocytopenia

- Known positive serology for HIV

- Mental illness or other condition preventing full cooperation with the treatment and
monitoring requirements of the study.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

D-0007

NCT ID:

NCT00043381

Start Date:

April 2001

Completion Date:

April 2003

Related Keywords:

  • Myelodysplastic Syndrome
  • myelodysplastic syndrome
  • MDS
  • chronic myelomonocytic leukemia
  • CMML
  • decitabine
  • 5-aza-2'deoxycytidine
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
New England Medical Center HospitalBoston, Massachusetts  02111
Scripps ClinicLa Jolla, California  92037
University of Illinois at ChicagoChicago, Illinois  60612
Mount Sinai Medical CenterNew York, New York  10029
City of Hope National Medical CenterLos Angeles, California  91010
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Duke University Medical CenterDurham, North Carolina  27710
University of FloridaGainesville, Florida  32610-0277
Rush Medical CenterChicago, Illinois  60612
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Massachusetts Medical SchoolWorcester, Massachusetts  01605
Loma Linda Univ. Cancer CenterLoma Linda, California  
Univ. California San Francisco Medical SchoolSan Francisco, California  
James A. Haley Veteran's HospitalTampa, Florida  
VA Medical CenterMinneapolis, Minnesota  
Washington Univ. School of MedicineSt. Louis, Missouri  
UNC Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  
The Memphis Cancer CenterMemphis, Tennessee  
SW Regional Cancer Center (dba Central Texas Oncology Associates)Austin, Texas  
Texas OncologyDallas, Texas