Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345345
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2006-06-27
Brief Title:
Alemtuzumab Campath to Treat T-Large Granular Lymphocyte Leukemia
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of T-Large Granular Lymphocyte T-LGL Lymphoproliferative Disorders With Alemtuzumab Campath
Status:
COMPLETED
Status Verified Date:
2021-03
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:
This study will examine the use of alemtuzumab Campath in patients with T cell large granular lymphocytic leukemia T-LGL Patients with T-LGL often have reduced white blood cells red blood cells and platelets and increased numbers of abnormal cells called large granular lymphocytes LGLs Patients may have recurrent infections anemia or abnormal bleeding Campath destroys specific parts of the abnormal LGLs which interfere with the production of normal blood cells This study will determine whether Campath can increase blood counts and reduce the number of abnormal LGLs in patients and will examine the side effects of the drug
Patients 18 to 85 years of age with T-LGL leukemia may be eligible for this study Participants undergo the following procedures
Before starting Campath treatment
Medical history and physical examination blood tests electrocardiogram ECG
Echocardiogram heart ultrasound and 24-hour Holter monitoring continuous ECG recording
Bone marrow biopsy About a tablespoon of bone marrow is withdrawn through a needle inserted into the hipbone The procedure is done using local anesthetic
Placement of central line if needed An intravenous line tube is placed into a major vein in the chest It can stay in the body and be used for the entire treatment period The line is used to give chemotherapy or other medications including antibiotics and blood transfusions and to collect blood samples The line is usually placed under local anesthesia in the radiology department or the operating room
Apheresis A catheter plastic tube is placed in a vein in each arm Blood is drawn from one vein and run through a cell-separating machine where the white blood cells are collected and saved The remaining blood is transfused back to the patients through the vein in the other arm
During Campath treatment
Campath therapy After a small test dose patients receive10 daily infusions of Campath each of which lasts about 2 hours The first few infusions are given at the NIH Clinical Center so that the patient can be monitored closely
Induction therapy Aerosolized pentamadine valacyclovir and other medicines are given to protect against or treat various infections that commonly affect patients with suppressed immune systems
Whole blood or platelet transfusions if needed and injections of growth factors if needed
Blood tests and check of vital signs temperature pulse blood pressure every day during treatment Echocardiogram and 24-hour Holter monitor after the last dose of Campath
Follow-up evaluations after Campath treatment ends
Blood tests at home or at NIH weekly for the first 3 months then every other week until 6 months then annually for 5 years
Echocardiogram at NIH at 3 months only
Bone marrow biopsy at NIH at 6 and 12 months then as clinically indicated
One repeat apheresis collection for laboratory studies
Patients 18 to 85 years of age with T-LGL leukemia may be eligible for this study Participants undergo the following procedures
Before starting Campath treatment
Medical history and physical examination blood tests electrocardiogram ECG
Echocardiogram heart ultrasound and 24-hour Holter monitoring continuous ECG recording
Bone marrow biopsy About a tablespoon of bone marrow is withdrawn through a needle inserted into the hipbone The procedure is done using local anesthetic
Placement of central line if needed An intravenous line tube is placed into a major vein in the chest It can stay in the body and be used for the entire treatment period The line is used to give chemotherapy or other medications including antibiotics and blood transfusions and to collect blood samples The line is usually placed under local anesthesia in the radiology department or the operating room
Apheresis A catheter plastic tube is placed in a vein in each arm Blood is drawn from one vein and run through a cell-separating machine where the white blood cells are collected and saved The remaining blood is transfused back to the patients through the vein in the other arm
During Campath treatment
Campath therapy After a small test dose patients receive10 daily infusions of Campath each of which lasts about 2 hours The first few infusions are given at the NIH Clinical Center so that the patient can be monitored closely
Induction therapy Aerosolized pentamadine valacyclovir and other medicines are given to protect against or treat various infections that commonly affect patients with suppressed immune systems
Whole blood or platelet transfusions if needed and injections of growth factors if needed
Blood tests and check of vital signs temperature pulse blood pressure every day during treatment Echocardiogram and 24-hour Holter monitor after the last dose of Campath
Follow-up evaluations after Campath treatment ends
Blood tests at home or at NIH weekly for the first 3 months then every other week until 6 months then annually for 5 years
Echocardiogram at NIH at 3 months only
Bone marrow biopsy at NIH at 6 and 12 months then as clinically indicated
One repeat apheresis collection for laboratory studies
Detailed Description:
T Cell Large Granular Lymphocyte T-LGL lymphoproliferative disorders are a heterogeneous group of uncommon diseases which may involve a monoclonal or oligoclonal T cell population which bear characteristic surface markers corresponding to activated cytotoxic CD3 CD8 lymphocytes They are often associated with quite severe neutropenia anemia and thrombocytopenia which may be life-threatening There is some evidence that the abnormal cytotoxic lymphocyte population may cause the cytopenias by suppressing hematopoiesis although the mechanism is unclear Immunosuppressive therapy has been shown to improve the cytopenias of T-LGL leukemia however the long-term use of the commonly used agents often lead to significant toxicity in the older patients which are affected by this disease
Alemtuzumab CampathR is currently approved as second line agent in patients with chronic lymphocytic leukemia CLL and has been used successfully in the treatment of certain autoimmune disorders In the Hematology Branch Campath is currently being investigated in two bone marrow failure syndromes aplastic anemia and myelodysplasia Cytopenias is an important characteristic of patients with T-LGL leukemia often being the indication for immunosuppressive therapy Our preliminary experience with Campath indicates that it is well tolerated among the elderly patients
Therefore we propose this pilot Phase II single agent study which will evaluate the efficacy and safety of alemtuzumab CampathR an immunosuppressive drug in subjects with T-LGL leukemia Commercially available Alemtuzumab CampathR will be administered off label at 10 mg per day by intravenous infusion for 10 days total Subjects who do not show a response to initial Campath or relapse may receive a second cycle of drug after the 3-month time point
The primary end point of the study is the response rate at three months defined as improvement in cytopenias Secondary endpoints will include relapse-free survival response at 6 months life threatening toxicity reduction in the number of abnormal T-LGL clone response to second cycle of Campath and overall survival
Alemtuzumab CampathR is currently approved as second line agent in patients with chronic lymphocytic leukemia CLL and has been used successfully in the treatment of certain autoimmune disorders In the Hematology Branch Campath is currently being investigated in two bone marrow failure syndromes aplastic anemia and myelodysplasia Cytopenias is an important characteristic of patients with T-LGL leukemia often being the indication for immunosuppressive therapy Our preliminary experience with Campath indicates that it is well tolerated among the elderly patients
Therefore we propose this pilot Phase II single agent study which will evaluate the efficacy and safety of alemtuzumab CampathR an immunosuppressive drug in subjects with T-LGL leukemia Commercially available Alemtuzumab CampathR will be administered off label at 10 mg per day by intravenous infusion for 10 days total Subjects who do not show a response to initial Campath or relapse may receive a second cycle of drug after the 3-month time point
The primary end point of the study is the response rate at three months defined as improvement in cytopenias Secondary endpoints will include relapse-free survival response at 6 months life threatening toxicity reduction in the number of abnormal T-LGL clone response to second cycle of Campath and overall survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 06-H-0190 | None | None | None |