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
Recruitment status was Active, not recruiting
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
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
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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:
MedlinePlus related topics:
Anemia
Cancer
Chronic Myeloid Leukemia
Leukemia
Myelodysplastic Syndromes
Drug Information available for:
Decitabine
U.S. FDA Resources
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) |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043134
Show 46 Study Locations
Show 46 Study LocationsSponsors 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:
|
Neoplasms Leukemia Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Leukemia, Myeloid Bone Marrow Diseases |
Hematologic Diseases Precancerous Conditions Decitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013