Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301821
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2006-03-09
Brief Title:
Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II Stage III or Stage IV Diffuse Large B-Cell Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of Epratuzumab Rituximab ER-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2019-10
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 epratuzumab and rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Drugs used in chemotherapy such as cyclophosphamide doxorubicin vincristine and prednisone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells PURPOSE This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II stage III or stage IV diffuse large B-cell lymphoma
Detailed Description:
OBJECTIVES Primary
Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide doxorubicin hydrochloride vincristine and prednisone CHOP as measured by 12-month event-free survival in patients with previously untreated stage II III or IV diffuse large B-cell lymphoma
Assess the use of positron emission tomography PET scan routinely early in treatment and after completion of treatment
Assess the functional response rate complete response partial response or stable disease by CT scan and PET negative in patients treated with this regimen
Assess the safety of this treatment regimen Secondary
Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen OUTLINE This is a multicenter study Patients receive epratuzumab IV over 1 hour on day 1 rituximab IV over 4-8 hours on day 1 or days 1 and 2 cyclophosphamide IV doxorubicin hydrochloride IV and vincristine IV on day 1 or 2 and oral prednisone on days 1-5 or 2-6 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed periodically for up to 5 years PROJECTED ACCRUAL A total of 86 patients will be accrued for this study
Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide doxorubicin hydrochloride vincristine and prednisone CHOP as measured by 12-month event-free survival in patients with previously untreated stage II III or IV diffuse large B-cell lymphoma
Assess the use of positron emission tomography PET scan routinely early in treatment and after completion of treatment
Assess the functional response rate complete response partial response or stable disease by CT scan and PET negative in patients treated with this regimen
Assess the safety of this treatment regimen Secondary
Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen OUTLINE This is a multicenter study Patients receive epratuzumab IV over 1 hour on day 1 rituximab IV over 4-8 hours on day 1 or days 1 and 2 cyclophosphamide IV doxorubicin hydrochloride IV and vincristine IV on day 1 or 2 and oral prednisone on days 1-5 or 2-6 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed periodically for up to 5 years PROJECTED ACCRUAL A total of 86 patients will be 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 |
|---|---|---|---|
| NCI-2012-02685 | REGISTRY | None | None |
| CDR0000459932 | REGISTRY | PDQ Physician Data Query | None |