Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074074
Status:
COMPLETED
Last Update Posted:
2012-07-16
First Post:
2003-12-10
Brief Title:
Infliximab in Treating Patients With Myelodysplastic Syndrome
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase II Trial With Infliximab Remicade in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia
Status:
COMPLETED
Status Verified Date:
2012-07
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 Monoclonal antibodies such as infliximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Randomized phase II trial to study the effectiveness of infliximab in treating patients who have myelodysplastic syndrome
PURPOSE Randomized phase II trial to study the effectiveness of infliximab in treating patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine the therapeutic activity of 2 different doses of infliximab on peripheral blood cell count and peripheral and bone marrow blast cell count in patients with low- or intermediate-risk myelodysplastic syndromes
Determine the subjective and objective toxicity of these regimens in these patients
Determine the response rates complete and partial response and hematological improvement in patients treated with these regimens
Determine the duration of response in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to cytogenetics good vs intermediate vs unknown due to failure overall International Prognostic Scoring System score low 0 vs intermediate 1 05-10 vs intermediate 2 15-20 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive infliximab IV on days 1 15 43 71 99 127 155 and 183 in the absence of disease progression or unacceptable toxicity
Arm II Patients receive a higher dose of infliximab as in arm I Patients achieving response complete or partial response or hematological improvement continue therapy beyond day 183 in the absence of disease progression
Patients are followed at 2 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm will be accrued for this study within 2 years
Determine the therapeutic activity of 2 different doses of infliximab on peripheral blood cell count and peripheral and bone marrow blast cell count in patients with low- or intermediate-risk myelodysplastic syndromes
Determine the subjective and objective toxicity of these regimens in these patients
Determine the response rates complete and partial response and hematological improvement in patients treated with these regimens
Determine the duration of response in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to cytogenetics good vs intermediate vs unknown due to failure overall International Prognostic Scoring System score low 0 vs intermediate 1 05-10 vs intermediate 2 15-20 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive infliximab IV on days 1 15 43 71 99 127 155 and 183 in the absence of disease progression or unacceptable toxicity
Arm II Patients receive a higher dose of infliximab as in arm I Patients achieving response complete or partial response or hematological improvement continue therapy beyond day 183 in the absence of disease progression
Patients are followed at 2 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm will be accrued for this study within 2 years
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 |
|---|---|---|---|
| EORTC-06023 | None | None | None |