Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00288626
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2006-02-07
Brief Title:
High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis HALT MS Study
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine Etoposide Cytarabine Melphalan Thymoglobulin and Autologous CD34 Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2017-08
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 effectiveness of a new treatment for multiple sclerosis MS a serious disease in which the immune system attacks the brain and spinal cord MS can be progressive and severe and lead to significant disability The study treatment involves the use of high-dose chemotherapeutic drugs to suppress the immune system The participants own autologous blood-forming hematopoietic CD34 stem cells are collected before the chemotherapy is given and then transplanted back into the body following treatment Transplantation of autologous hematopoietic stem cells is required to prevent very prolonged periods of low blood cell counts after the high-dose chemotherapy
Detailed Description:
MS is a chronic autoimmune disease of the central nervous system in which myelin the protective coat that surrounds nerve cells is damaged or destroyed by autoimmune T cells and macrophages leading to an eventual loss of neurologic function In a pilot study in Europe using high-dose chemotherapy it was observed that 18 of 19 MS patients stabilized or improved clinically and only one patient showed a new lesion on magnetic resonance imaging MRI of the brain at 45 years after treatment Improvement was seen in quality-of-life assessments
In ITN033AI high-dose chemotherapy with autologous CD34-selected hematopoietic cell transplantation will be given to confirm the results from the pilot study and to offer therapy to patients with early MS and a poor prognosis Research studies will be performed in addition to clinical assessments to better understand the effect of the treatment on the activity of MS High-dose chemotherapy will be used to deplete autoreactive immune cells These regimens also deplete the bone marrow the source of blood-forming CD34 stem cells which causes very low blood counts Therefore the participants autologous CD34 hematopoietic stem cells will be collected before high dose immunosuppressive therapy is given and then returned as a transplant post-chemotherapy Patients will be followed closely after the autologous transplantation since they will be at risk for infections after treatment
At the beginning of the study participants will undergo a number of screening and baseline procedures including a physical exam blood collection MS-confirming neurology exams and questionnaires and MRI procedures Participants will be given prednisone and granulocyte-colony stimulating factor G-CSF to mobilize CD34 hematopoietic stem cells from the bone marrow into the peripheral blood When the peripheral blood CD34 cell count reaches 20000 cellsml or greater these cells will be collected by leukapheresis In this process a catheter is placed into a large blood vessel peripheral blood is withdrawn and a high speed sedimentation leukapheresis device is used to separate and retain the cells required for autologous transplantation Other blood cells are then returned to the participants body In the laboratory the CD34 hematopoietic stem cell graft will be selected and prepared from the leukapheresis collection and stored until needed for transplant Seven or more days following the collection of their autologous graft participants will be hospitalized and receive high-dose chemotherapy consisting of carmustine etoposide cytarabine and melphalan BEAM and thymoglobulin This is followed by transplantation of the autologous hematopoietic cell graft Participants will remain in the hospital for observation during recovery of their peripheral blood cell counts as described in the protocol Participants will receive G-CSF and blood transfusions if needed and will be monitored for infections Following discharge from the hospital eight study visits will occur over sixty months five years During these visits participants will undergo blood and urine collection MRI studies leukapheresis and MS neurology exams and will complete questionnaires
In ITN033AI high-dose chemotherapy with autologous CD34-selected hematopoietic cell transplantation will be given to confirm the results from the pilot study and to offer therapy to patients with early MS and a poor prognosis Research studies will be performed in addition to clinical assessments to better understand the effect of the treatment on the activity of MS High-dose chemotherapy will be used to deplete autoreactive immune cells These regimens also deplete the bone marrow the source of blood-forming CD34 stem cells which causes very low blood counts Therefore the participants autologous CD34 hematopoietic stem cells will be collected before high dose immunosuppressive therapy is given and then returned as a transplant post-chemotherapy Patients will be followed closely after the autologous transplantation since they will be at risk for infections after treatment
At the beginning of the study participants will undergo a number of screening and baseline procedures including a physical exam blood collection MS-confirming neurology exams and questionnaires and MRI procedures Participants will be given prednisone and granulocyte-colony stimulating factor G-CSF to mobilize CD34 hematopoietic stem cells from the bone marrow into the peripheral blood When the peripheral blood CD34 cell count reaches 20000 cellsml or greater these cells will be collected by leukapheresis In this process a catheter is placed into a large blood vessel peripheral blood is withdrawn and a high speed sedimentation leukapheresis device is used to separate and retain the cells required for autologous transplantation Other blood cells are then returned to the participants body In the laboratory the CD34 hematopoietic stem cell graft will be selected and prepared from the leukapheresis collection and stored until needed for transplant Seven or more days following the collection of their autologous graft participants will be hospitalized and receive high-dose chemotherapy consisting of carmustine etoposide cytarabine and melphalan BEAM and thymoglobulin This is followed by transplantation of the autologous hematopoietic cell graft Participants will remain in the hospital for observation during recovery of their peripheral blood cell counts as described in the protocol Participants will receive G-CSF and blood transfusions if needed and will be monitored for infections Following discharge from the hospital eight study visits will occur over sixty months five years During these visits participants will undergo blood and urine collection MRI studies leukapheresis and MS neurology exams and will complete questionnaires
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAIT SCMS2 | None | None | None |