Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324779
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2006-05-10
Brief Title:
Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkins Lymphoma or B-Cell Acute Lymphoblastic Leukemia
Sponsor:
University Hospital Erlangen
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
Status:
COMPLETED
Status Verified Date:
2015-09
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 rituximab can block cancer growth in different ways Some find cancer cells and kill them or carry cancer-killing substances to them Others interfere with the ability of cancer cells to grow and spread Giving rituximab before chemotherapy may be an effective treatment for B-cell non-Hodgkins lymphoma or B-cell acute lymphoblastic leukemia
PURPOSE This phase II trial is studying how well rituximab works in treating young patients who are planning to receive chemotherapy for B-cell non-Hodgkins lymphoma or B-cell acute lymphoblastic leukemia
PURPOSE This phase II trial is studying how well rituximab works in treating young patients who are planning to receive chemotherapy for B-cell non-Hodgkins lymphoma or B-cell acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Determine the response rate in children and adolescents with B-cell non-Hodgkins lymphoma B-NHL or B-cell acute lymphoblastic leukemia B-ALL treated with rituximab monotherapy as upfront window therapy before chemotherapy
Evaluate the effect of rituximab on different histological subtypes of childhood mature B-NHL or B-ALL in patients treated with this regimen
Investigate the rituximab response in patients treated with this regimen
Determine the toxicity profile of rituximab in these patients
Collect pharmacokinetic and pharmacodynamic data from patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive rituximab IV on day 1
PROJECTED ACCRUAL A total of 79 patients will be accrued for this study
Determine the response rate in children and adolescents with B-cell non-Hodgkins lymphoma B-NHL or B-cell acute lymphoblastic leukemia B-ALL treated with rituximab monotherapy as upfront window therapy before chemotherapy
Evaluate the effect of rituximab on different histological subtypes of childhood mature B-NHL or B-ALL in patients treated with this regimen
Investigate the rituximab response in patients treated with this regimen
Determine the toxicity profile of rituximab in these patients
Collect pharmacokinetic and pharmacodynamic data from patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive rituximab IV on day 1
PROJECTED ACCRUAL A total of 79 patients will be accrued for this study
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 |
|---|---|---|---|
| NHL-BFM-RITUXIMAB | None | None | None |
| B-NHL-BFM-Rituximab | None | None | None |
| EU-205119 | None | None | None |