Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323323
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2006-05-08
Brief Title:
CHOP and Campath-1H in Previously Untreated Aggressive TNK-Cell Lymphomas
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Study of CHOP and Campath-1H in Previously Untreated Aggressive TNK-Cell Lymphomas
Status:
COMPLETED
Status Verified Date:
2017-01
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:
Purpose This study will evaluate the safety of CHOP plus Alemtuzumab in patients with TNK cell lymphomas and CD-20 negative large B-cell lymphomas who have not had previous treatments The biological response of lymphoma cells and the immune system to this drug combination will also be measured in patients before during and after therapy administration
Detailed Description:
Rationale The drug combination called CHOP or Cyclophosphamide Cytoxan Doxorubicin Adriamycin Vincristine Oncovin and Prednisone Deltasone has been used against different types of lymphoma for many years Researchers are investigating what other therapies to combine with the CHOP regimen to improve outcomes for patients with lymphoma The current study combines CHOP with alemtuzumab a monoclonal antibody used against leukemia Monoclonal antibodies are a type of immunotherapy used against some types of cancer They are produced in a laboratory and designed to target as well as bind with cells that carry specific proteins Alemtuzumab is designed to target leukemia cells that express a specific protein The specific protein recognized by alemtuzumab is the CD52 antigen This antigen or substance that causes the immune system to create a specific response is expressed on normal B and T cells as well as on abnormal T cells characteristic of certain cancers Alemtuzumab causes the CD52 antigen to bind with B-cell lymphocytes This study will also assess the theory that alemtuzumab may increase the effectiveness of the chemotherapy agents included in the CHOP regimen
Treatment Patients in this study will receive alemtuzumab and CHOP Alemtuzumab will be given through injections into the skin and CHOP will be administered through intravenous infusions Patients will receive alemtuzumab alone during the first week of the study An increasing amount of alemtuzumab will be given during the first week If patients cannot tolerate the highest amount of alemtuzumab determined as appropriate within one week they will be removed from the study Once the highest dose of alemtuzumab has been achieved patients will then receive both alemtuzumab and CHOP every three weeks This schedule will be repeated up to eight times Several tests and exams will be given throughout the study to closely monitor patients Treatments will be discontinued due to disease growth or unacceptable side effects
Treatment Patients in this study will receive alemtuzumab and CHOP Alemtuzumab will be given through injections into the skin and CHOP will be administered through intravenous infusions Patients will receive alemtuzumab alone during the first week of the study An increasing amount of alemtuzumab will be given during the first week If patients cannot tolerate the highest amount of alemtuzumab determined as appropriate within one week they will be removed from the study Once the highest dose of alemtuzumab has been achieved patients will then receive both alemtuzumab and CHOP every three weeks This schedule will be repeated up to eight times Several tests and exams will be given throughout the study to closely monitor patients Treatments will be discontinued due to disease growth or unacceptable side effects
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