Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003138
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
1999-11-01
Brief Title:
Erythropoietin EPO- Filgrastim G-CSF vs Supportive Therapy Alone for Patients With Myelodysplastic Syndromes
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase III Evaluation of EPO With or Without G-CSF Versus Supportive Therapy Alone in the Treatment of Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
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 Erythropoietin and colony-stimulating factors such as filgrastim stimulate the production of blood cells It is not yet known whether erythropoietin with or without filgrastim is more effective than standard blood transfusions in reducing the need for transfusions in patients who have anemia associated with myelodysplastic syndrome
PURPOSE Randomized phase III trial to compare the effectiveness of erythropoietin with or without filgrastim with that of standard blood transfusions in reducing the need for transfusions in patients who have anemia associated with myelodysplastic syndrome
PURPOSE Randomized phase III trial to compare the effectiveness of erythropoietin with or without filgrastim with that of standard blood transfusions in reducing the need for transfusions in patients who have anemia associated with myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Compare the benefit of erythropoietin vs standard transfusion support in reducing transfusion requirements in patients with myelodysplastic syndromes
Compare the clinical response disease progression and survival in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Evaluate whether adding filgrastim G-CSF or increasing the erythropoietin dose will reduce the transfusion requirement in patients who do not respond to erythropoietin alone
To compare the benefit of erythropoietin versus supportive care alone on quality of life QOL in persons with myelodysplastic syndromes
OUTLINE This is a randomized controlled multicenter cross-over study Patients are stratified according to morphologic subtype refractory anemia RA vs RA with ringed sideroblasts vs RA with excess blasts transfusion requirement yes vs no prior erythropoietin treatment yes vs no and erythropoietin level at least 200 mUmL vs less than 200 mUmL Patients are randomized to one of two treatment arms
Arm I standard transfusion support Patients receive red cell and platelet transfusions for symptoms or to maintain hematocrit level of 25 or above Patients undergo bone marrow aspirate and biopsy at 4 months and then every year until development of acute leukemia or completion of study Patients with progressive disease may cross over to arm II after at least 4 months on study and up to 1 year from the time of randomization Patients who cross over receive erythropoietin alone
Arm II Erythropoietin Patients receive erythropoietin subcutaneously SC or intravenously IV daily Patients undergo bone marrow aspirate and biopsy as in arm I Treatment continues daily for a maximum of 1 year
Patients with stable or progressive disease at day 120 receive filgrastim G-CSF SC daily or 3 days a week and erythropoietin SC daily for up to 6 months Patients with no response to G-CSF and lower-dose erythropoietin may proceed to a higher dose of erythropoietin
Quality of life is assessed at baseline every 4 months during study and at study completion
Patients are followed every 4 months for 2 years every 6 months for 3 years and then annually for 5 years
ACTUAL ACCRUAL A total of 118 patients were accrued for this study
Compare the benefit of erythropoietin vs standard transfusion support in reducing transfusion requirements in patients with myelodysplastic syndromes
Compare the clinical response disease progression and survival in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Evaluate whether adding filgrastim G-CSF or increasing the erythropoietin dose will reduce the transfusion requirement in patients who do not respond to erythropoietin alone
To compare the benefit of erythropoietin versus supportive care alone on quality of life QOL in persons with myelodysplastic syndromes
OUTLINE This is a randomized controlled multicenter cross-over study Patients are stratified according to morphologic subtype refractory anemia RA vs RA with ringed sideroblasts vs RA with excess blasts transfusion requirement yes vs no prior erythropoietin treatment yes vs no and erythropoietin level at least 200 mUmL vs less than 200 mUmL Patients are randomized to one of two treatment arms
Arm I standard transfusion support Patients receive red cell and platelet transfusions for symptoms or to maintain hematocrit level of 25 or above Patients undergo bone marrow aspirate and biopsy at 4 months and then every year until development of acute leukemia or completion of study Patients with progressive disease may cross over to arm II after at least 4 months on study and up to 1 year from the time of randomization Patients who cross over receive erythropoietin alone
Arm II Erythropoietin Patients receive erythropoietin subcutaneously SC or intravenously IV daily Patients undergo bone marrow aspirate and biopsy as in arm I Treatment continues daily for a maximum of 1 year
Patients with stable or progressive disease at day 120 receive filgrastim G-CSF SC daily or 3 days a week and erythropoietin SC daily for up to 6 months Patients with no response to G-CSF and lower-dose erythropoietin may proceed to a higher dose of erythropoietin
Quality of life is assessed at baseline every 4 months during study and at study completion
Patients are followed every 4 months for 2 years every 6 months for 3 years and then annually for 5 years
ACTUAL ACCRUAL A total of 118 patients were accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA021115 | NIH | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| E1996 | OTHER | None | None |