Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453427
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2007-03-27
Brief Title:
Alemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas
Sponsor:
Ontario Clinical Oncology Group OCOG
Organization:
Ontario Clinical Oncology Group OCOG
Study Overview
Official Title:
Alemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas A Multi-centre Phase I and II Study
Status:
COMPLETED
Status Verified Date:
2015-06
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:
ACCAPELA
Brief Summary:
The primary objectives of this study are to
1 establish the safety and dose limiting toxicities of combining alemtuzumab with CHOP chemotherapy for patients with newly diagnosed aggressive T-cell lymphomas and
2 to measure the pharmacokinetics of alemtuzumab used in different subcutaneous doses and schedules
This will then determine the dose with the highest achievable drug levels with acceptable toxicities worthy of further investigation
The secondary objectives are to
1 establish the efficacy of combination alemtuzumab with CHOP chemotherapy and
2 to measure the effects of combination alemtuzumab with CHOP chemotherapy on T-cell reconstitution and cytomegalovirus CMV reactivation
1 establish the safety and dose limiting toxicities of combining alemtuzumab with CHOP chemotherapy for patients with newly diagnosed aggressive T-cell lymphomas and
2 to measure the pharmacokinetics of alemtuzumab used in different subcutaneous doses and schedules
This will then determine the dose with the highest achievable drug levels with acceptable toxicities worthy of further investigation
The secondary objectives are to
1 establish the efficacy of combination alemtuzumab with CHOP chemotherapy and
2 to measure the effects of combination alemtuzumab with CHOP chemotherapy on T-cell reconstitution and cytomegalovirus CMV reactivation
Detailed Description:
Aggressive peripheral T-cell lymphomas account for 10 - 15 of all Non-Hodgkins Lymphoma NHL and present with more adverse prognostic features than aggressive histology B-cell NHL Correspondingly they have an overall poorer prognosis than B-cell lymphomas achieving lower complete response rates freedom from progression and overall survival with conventional anthracycline-based CHOP cyclophosphamide doxorubicin vincristine and prednisone chemotherapy Fewer than 30 of patients are cured with therapy New treatments that replicate the improved survivals with chemo-immunotherapy for B-cell lymphomas are needed Alemtuzumab is a humanized murine antibody that binds to a ubiquitous lymphoid marker CD52 and is efficacious as monotherapy in related lymphoproliferative diseases Combining alemtuzumab with CHOP chemotherapy may improve the response rates and outcomes of patients with this sub-type of NHL The combination must be first tested in a dose escalation fashion to establish the dosage of the doublet because of the potential for overlapping or exaggerated toxicities
This prospective multi-center open label Phase I-II study will enroll 22-84 patients with newly diagnosed previously untreated aggressive histology peripheral T-cell lymphomas In the Phase I component patients will be sequentially enrolled in cohorts of three patients and treated with increasing doses of alemtuzumab administered in combination with standard CHOP chemotherapy When the maximal tolerated dose is determined this dose and schedule will then be tested in up to 46 patients using a Simon two stage Phase II design
This prospective multi-center open label Phase I-II study will enroll 22-84 patients with newly diagnosed previously untreated aggressive histology peripheral T-cell lymphomas In the Phase I component patients will be sequentially enrolled in cohorts of three patients and treated with increasing doses of alemtuzumab administered in combination with standard CHOP chemotherapy When the maximal tolerated dose is determined this dose and schedule will then be tested in up to 46 patients using a Simon two stage Phase II design
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