Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043134
Status:
UNKNOWN
Last Update Posted:
2010-04-13
First Post:
2002-08-05
Brief Title:
Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2008-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT-2005-002830 | None | None | None |
| EORTC-06011 | None | None | None |
| SUPERGEN-EORTC-06011 | None | None | None |
| GMDSG-EORTC-06011 | None | None | None |