Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040651
Status:
TERMINATED
Last Update Posted:
2007-12-28
First Post:
2002-07-05
Brief Title:
Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Transplantation With T-Cell Depleted Autologous Peripheral Stem Cells for Severe Systemic Sclerosis A Phase I Dose Escalation Study
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Scleroderma or systemic sclerosis SSc is a diffuse connective tissue disease characterized by changes in the skin blood vessels skeletal muscles and internal organs The purpose of this study is to determine the safety and value of self bone marrow transplants after chemotherapy in patients with severe SSc
Detailed Description:
SSc is a chronic disease involving the abnormal growth of connective tissue which supports the skin and internal organs This disease can affect the skin making it hard and tight it can also damage the blood vessels and internal organs such as the heart lungs and kidneys Initially precursor blood cells will be mobilized from the bone marrow into the blood stream after chemotherapy and white blood cell growth factors are administered These precursors or autologous stem cells can be harvested from the bloodstream in a procedure called leukapheresis it is the precursor blood cells that are transplanted back into the patients body after high dose chemotherapy Autologous stem cells are preferred over donor bone marrow because there is no risk of rejection This study will evaluate the safety and effectiveness of self bone marrow transplants after intravenous chemotherapy in patients with SSc
Prior to transplantation patients will undergo diphtheriatetanus DT vaccination and blood collection Two weeks after vaccination patients will have a Hickman catheter inserted into their bodies and will be admitted to the hospital to receive mobilization chemotherapy with intravenous IV cyclophosphamide Patients will be discharged after receiving the cyclophosphamide therapy with the understanding that they must stay locally and must return to the outpatient clinic daily to have blood samples drawn and to receive an injection of a growth factor G-CSF in stimulate blood cell production Patients will undergo leukapheresis at the clinic when their white blood cell WBC counts reach 2500 cellsmm3 or more A machine called the Nexell Isolex 300i will be used to remove T-cells from the cells collected by leukapheresis
After leukapheresis and other pre-transplant procedures have been completed patients will be hospitalized for approximately 14 to 21 days On Days 1 through 5 of hospitalization patients will receive IV fludarabine and one of several possible dose levels of cyclophosphamide On Days 3 through 5 patients will receive IV thymoglobulin to kill the T-cells that cause the damage from systemic sclerosis On Day 8 patients will receive their own stem cells from the previous leukapheresis procedure While in the hospital patients will be monitored by daily blood collection and will not be discharged until their white blood cell counts return to a safe stable level Prior to discharge from the hospital patients will undergo a second leukapheresis
Patients are required to stay locally in Pittsburgh up to 100 days post-transplantation Study visits will occur at the clinic every week for the first three months after transplant and again at 4 5 6 9 12 18 and 24 months post-transplantation Study visits will include a physical exam and blood collection patients will be also asked to complete a questionnaire Patients will undergo an electrocardiogram EKG at Month 1 a chest x-ray at Month 6 24-hour urine collection at Months 6 and 18 and pulmonary tests at Months 6 12 and 24 Additional leukapheresis will be conducted at 12 and 24 months post-transplant to assess patients health
Prior to transplantation patients will undergo diphtheriatetanus DT vaccination and blood collection Two weeks after vaccination patients will have a Hickman catheter inserted into their bodies and will be admitted to the hospital to receive mobilization chemotherapy with intravenous IV cyclophosphamide Patients will be discharged after receiving the cyclophosphamide therapy with the understanding that they must stay locally and must return to the outpatient clinic daily to have blood samples drawn and to receive an injection of a growth factor G-CSF in stimulate blood cell production Patients will undergo leukapheresis at the clinic when their white blood cell WBC counts reach 2500 cellsmm3 or more A machine called the Nexell Isolex 300i will be used to remove T-cells from the cells collected by leukapheresis
After leukapheresis and other pre-transplant procedures have been completed patients will be hospitalized for approximately 14 to 21 days On Days 1 through 5 of hospitalization patients will receive IV fludarabine and one of several possible dose levels of cyclophosphamide On Days 3 through 5 patients will receive IV thymoglobulin to kill the T-cells that cause the damage from systemic sclerosis On Day 8 patients will receive their own stem cells from the previous leukapheresis procedure While in the hospital patients will be monitored by daily blood collection and will not be discharged until their white blood cell counts return to a safe stable level Prior to discharge from the hospital patients will undergo a second leukapheresis
Patients are required to stay locally in Pittsburgh up to 100 days post-transplantation Study visits will occur at the clinic every week for the first three months after transplant and again at 4 5 6 9 12 18 and 24 months post-transplantation Study visits will include a physical exam and blood collection patients will be also asked to complete a questionnaire Patients will undergo an electrocardiogram EKG at Month 1 a chest x-ray at Month 6 24-hour urine collection at Months 6 and 18 and pulmonary tests at Months 6 12 and 24 Additional leukapheresis will be conducted at 12 and 24 months post-transplant to assess patients health
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 |
|---|---|---|---|
| NIAMS-047 | None | None | None |