Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142181
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2005-09-01
Brief Title:
Phase II Study of Campath-1H Antibody to Treat Waldenstroms Macroglobulinemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study of Campath-1H in Patients With Lymphoplasmacytic Lymphoma Waldenstroms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2012-12
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:
The purpose of this study is to determine the safety and effects good or bad of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma
Detailed Description:
Patients will receive 3 test doses of Campath-1H 3mg 10mg 30mg If the patient tolerates these three test doses then they will receive a total of 6 weeks of Campath-1H therapy three times a week
After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose they will be re-assessed by blood testing If it is determined that their disease has progressed in the period of time while the patient was on Campath-1H the patient will be removed from the study
If it is determined that the patient has achieved a complete remission after 6 weeks of Campath-1H treatment a bone marrow biopsy will be performed to confirm complete remission and the patient will not receive any additional treatment but will be followed for a period of 2 years
If the disease has remained stable or partial response has been achieved the patient will enter the second phase of therapy in which they will receive an additional 6 weeks of Campath-1H therapy The patient will then be reassessed as described above
No additional therapy as part of this study will be performed after a 12 week course of Campath-1H
While the patient is on Campath-1H blood test will be performed at 3-6 month intervals over a period extending for 2 years following the last treatment Bone marrow biopsies andor aspirations will be conducted as necessary
After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose they will be re-assessed by blood testing If it is determined that their disease has progressed in the period of time while the patient was on Campath-1H the patient will be removed from the study
If it is determined that the patient has achieved a complete remission after 6 weeks of Campath-1H treatment a bone marrow biopsy will be performed to confirm complete remission and the patient will not receive any additional treatment but will be followed for a period of 2 years
If the disease has remained stable or partial response has been achieved the patient will enter the second phase of therapy in which they will receive an additional 6 weeks of Campath-1H therapy The patient will then be reassessed as described above
No additional therapy as part of this study will be performed after a 12 week course of Campath-1H
While the patient is on Campath-1H blood test will be performed at 3-6 month intervals over a period extending for 2 years following the last treatment Bone marrow biopsies andor aspirations will be conducted as necessary
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