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Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00043134
First received: August 5, 2002
Last updated: April 10, 2010
Last verified: April 2008
  Purpose

RATIONALE: Decitabine may help myelodysplasia cells develop into normal stem cells. It is not yet known if decitabine is more effective than standard supportive care in treating myelodysplastic syndrome.

PURPOSE: Randomized phase III trial to compare the effectiveness of low-dose decitabine with that of standard supportive care in treating older patients who have myelodysplastic syndrome.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Drug: decitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous Low-Dose Decitabine Versus Supportive Care in Elderly Patients With Primary Myelodysplastic Syndrome (MDS) (>10% Blasts or High-Risk Cytogenetics), Secondary MDS or Chronic Myelomonocytic Leukemia (CMML) Who Are Not Eligible for Intensive Therapy: An EORTC-German MDS Study Group Randomized Phase III Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Duration of overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best response rate as measured by Cheson response criteria [ Designated as safety issue: No ]
  • Overall progression-free survival [ Designated as safety issue: No ]
  • Toxicity as assessed by CTC v2.0 [ Designated as safety issue: Yes ]
  • Quality of life as assessed by EORTC QLQ30 [ Designated as safety issue: No ]
  • Days in Hospital [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: May 2002
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the efficacy of low-dose decitabine vs standard supportive care, in terms of overall survival, of elderly patients with myelodysplastic syndromes.
  • Compare the response rate and progression-free survival of patients treated with these regimens.
  • Determine the toxicity of decitabine in these patients.
  • Assess the duration of hospitalization and number of blood transfusions in patients treated with these regimens.
  • Assess the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to cytogenetic risk factors (good vs poor vs intermediate vs unknown), disease (primary myelodysplastic syndrome (MDS) vs secondary MDS), and participating center. Patients with a successful cytogenetic exam are also stratified according to overall International Prognostic Scoring System score (intermediate 1 vs intermediate 2 vs high risk). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive decitabine IV over 4 hours every 8 hours for 3 days. Treatment repeats every 6 weeks for 4-8 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive standard supportive care. Quality of life is assessed at baseline, every 6 weeks during therapy, every 2 months for 1 year, and then every 3 months thereafter.

Patients are followed every 2 months for 1 year and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of primary or secondary myelodysplastic syndromes (MDS)

    • Any FAB or WHO criteria cellular type allowed
  • Bone marrow blast count on aspiration or biopsy of 1 of the following:

    • No more than 10% with poor cytogenetic risk factors (defined as any numerical or structural abnormality of chromosome 7 and/or complex abnormalities)
    • 11-20%
    • 21-30% for patients with acute myeloid leukemia (AML) secondary to MDS (i.e., refractory anemia with excess blasts in transformation by FAB classification)
    • Patients who failed the cytogenetic exam are allowed provided bone marrow blasts are at least 5% and/or 2-3 cytopenias are present
  • No rapid progression towards full-blown AML
  • No blast crisis of chronic myeloid leukemia
  • No t(8;21) alone or in combination with other abnormalities
  • Ineligible for intensive chemotherapy (e.g., cytarabine or an anthracycline)

PATIENT CHARACTERISTICS:

Age

  • 60 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • Hepatitis B surface antigen negative

Renal

  • Creatinine less than 1.5 times ULN

Cardiovascular

  • No severe cardiovascular disease
  • No arrhythmias requiring chronic treatment
  • No congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No symptomatic ischemic heart disease

Other

  • HIV negative
  • No active uncontrolled infection
  • No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix within the past 2 years
  • No prior or concurrent evidence of CNS or psychiatric disorders requiring hospitalization
  • No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 6 weeks since prior growth factors for primary MDS
  • No concurrent antiangiogenic drugs (e.g., thalidomide)
  • No concurrent interleukin, interferon, or anti-thymocyte globulin

Chemotherapy

  • See Disease Characteristics
  • More than 6 weeks since prior hydroxyurea for primary MDS
  • No other prior chemotherapy for MDS or AML
  • Prior chemotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed

Endocrine therapy

  • No concurrent steroids (except as inhalation therapy)

Radiotherapy

  • Prior radiotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed

Surgery

  • Not specified

Other

  • More than 6 weeks since prior immunosuppressive agents for primary MDS
  • No concurrent amifostine
  • No concurrent cyclosporine
  • No other concurrent experimental therapies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043134

  Show 46 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Investigator: Pierre W. Wijermans, MD, PhD HagaZiekenhuis - Locatie Leyenburg
Investigator: Michael Luebbert, MD University Hospital Freiburg
  More Information

Additional Information:
Publications:
WijerMans P, Suciu S, Baila L, et al.: Low dose decitabine versus best supportive sare in elderly patients with intermediate or high risk MDS not eligible for intensive chemotherapy: final results of the randomizedpPhase III study (06011) of the EORTC Leukemia and German MDS Study Groups. [Abstract] Blood 112 (11): A-226, 2008.

ClinicalTrials.gov Identifier: NCT00043134     History of Changes
Other Study ID Numbers: CDR0000256224, EORTC-06011, SUPERGEN-EORTC-06011, GMDSG-EORTC-06011, EudraCT-2005-002830
Study First Received: August 5, 2002
Last Updated: April 10, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
chronic myelomonocytic leukemia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
refractory anemia
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
refractory anemia with ringed sideroblasts
refractory cytopenia with multilineage dysplasia
secondary myelodysplastic syndromes
atypical chronic myeloid leukemia, BCR-ABL negative
myelodysplastic/myeloproliferative neoplasm, unclassifiable

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Neoplasms
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Leukemia, Myeloid
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions
Decitabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014