Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363090
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2006-08-10
Brief Title:
Alemtuzumab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II Stage III or Stage IV T-Cell Non-Hodgkins Lymphoma
Sponsor:
Toronto Sunnybrook Regional Cancer Centre
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Alemtuzumab and CHOP Chemotherapy for Aggressive Histology Peripheral T Cell Lymphomas A Multi-Centre Phase I and II Study
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
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 Monoclonal antibodies such as alemtuzumab 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 growing Giving alemtuzumab together with combination chemotherapy may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed aggressive stage II stage III or stage IV T-cell non-Hodgkins lymphoma
PURPOSE This phase III trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed aggressive stage II stage III or stage IV T-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Establish the safety and dose-limiting toxicities of alemtuzumab in combination with cyclophosphamide doxorubicin hydrochloride vincristine and prednisone CHOP chemotherapy in patients with newly diagnosed stage II-IV aggressive peripheral T-cell non-Hodgkins lymphoma
Measure the pharmacokinetics of alemtuzumab using different subcutaneous doses and schedules to determine the dose with the highest achievable drug levels with acceptable toxicities worthy of further investigation
Secondary
Determine the efficacy of alemtuzumab in combination with CHOP chemotherapy using escalating doses and 2 different drug schedules as defined by overall response rate progression-free survival and overall survival
Measure the effects of this regimen on T-cell reconstitution and cytomegalovirus reactivation
OUTLINE This is a multicenter phase I dose-escalation study of alemtuzumab followed by an open-label phase II study
Phase I Patients receive CHOP chemotherapy comprising cyclophosphamide IV doxorubicin hydrochloride IV and vincristine IV on day 1 and oral prednisone on days 1-5 Patients also receive alemtuzumab subcutaneously SC on day 1 OR on days 1 8 and 15 Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of alemtuzumab until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive CHOP chemotherapy and alemtuzumab at the MTD determined in phase I as in phase I on the most effective regimen
Patients undergo blood collection at baseline periodically during study treatment and after completion of study treatment for pharmacokinetics and other correlative studies Samples are examined for presence of cytomegalovirus antigen and by flow cytometry for B- and T-cell quantification
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 84 patients will be accrued for this study
Primary
Establish the safety and dose-limiting toxicities of alemtuzumab in combination with cyclophosphamide doxorubicin hydrochloride vincristine and prednisone CHOP chemotherapy in patients with newly diagnosed stage II-IV aggressive peripheral T-cell non-Hodgkins lymphoma
Measure the pharmacokinetics of alemtuzumab using different subcutaneous doses and schedules to determine the dose with the highest achievable drug levels with acceptable toxicities worthy of further investigation
Secondary
Determine the efficacy of alemtuzumab in combination with CHOP chemotherapy using escalating doses and 2 different drug schedules as defined by overall response rate progression-free survival and overall survival
Measure the effects of this regimen on T-cell reconstitution and cytomegalovirus reactivation
OUTLINE This is a multicenter phase I dose-escalation study of alemtuzumab followed by an open-label phase II study
Phase I Patients receive CHOP chemotherapy comprising cyclophosphamide IV doxorubicin hydrochloride IV and vincristine IV on day 1 and oral prednisone on days 1-5 Patients also receive alemtuzumab subcutaneously SC on day 1 OR on days 1 8 and 15 Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of alemtuzumab until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive CHOP chemotherapy and alemtuzumab at the MTD determined in phase I as in phase I on the most effective regimen
Patients undergo blood collection at baseline periodically during study treatment and after completion of study treatment for pharmacokinetics and other correlative studies Samples are examined for presence of cytomegalovirus antigen and by flow cytometry for B- and T-cell quantification
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 84 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 |
|---|---|---|---|
| TSRCC-164-2006 | None | None | None |