Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005937
Status:
COMPLETED
Last Update Posted:
2014-10-23
First Post:
2000-07-06
Brief Title:
Antithymocyte Globulin and Cyclosporine to Treat Myelodysplasia
Sponsor:
Neal Young MD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of Antithymocyte Globulin ATG and Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome MDS
Status:
COMPLETED
Status Verified Date:
2014-10
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 determine the safety and effectiveness of a combination of the immune-suppressing drugs antithymocyte globulin ATG and cyclosporine for treating myelodysplasia a disorder of low blood cell counts It will evaluate whether this drug combination can increase blood counts in patients and reduce their need for transfusions compare survival of patients who respond to ATG and cyclosporine treatment with those who do not respond and determine the side effects of the treatment
Myelodysplasia is thought to result from an immune system abnormality in which cells called lymphocytes attack the marrows blood-forming cells The resulting deficiencies of platelets and red and white blood cells cause anemia susceptibility to infections and easy bruising and bleeding Various therapies such as blood transfusions for anemia and bleeding antibiotics for infection chemotherapy and bone marrow transplantation are used to treat myelodysplasia but all have disadvantages and some carry serious risks
Patients 18 years of age and older with myelodysplasia may be eligible for this study Candidates will be screened with a physical examination and medical history blood tests chest X-ray electrocardiogram and bone marrow biopsy removal of a marrow sample from the hipbone for microscopic examination
Myelodysplasia is thought to result from an immune system abnormality in which cells called lymphocytes attack the marrows blood-forming cells The resulting deficiencies of platelets and red and white blood cells cause anemia susceptibility to infections and easy bruising and bleeding Various therapies such as blood transfusions for anemia and bleeding antibiotics for infection chemotherapy and bone marrow transplantation are used to treat myelodysplasia but all have disadvantages and some carry serious risks
Patients 18 years of age and older with myelodysplasia may be eligible for this study Candidates will be screened with a physical examination and medical history blood tests chest X-ray electrocardiogram and bone marrow biopsy removal of a marrow sample from the hipbone for microscopic examination
Detailed Description:
Participants will be admitted to the NIH Clinical Center for the first 10 to 14 days of treatment and will then continue therapy on an outpatient basis They will undergo the following tests and procedures
Placement of central line-An intravenous IV catheter flexible tube inserted into a vein is placed in a large vein of the neck chest or arm Medicines are delivered through this line and blood samples are drawn from it
ATG skin testing- ATG is injected under the skin to check for sensitization to horse serum from which the drug is derived
ATG treatment-Four doses of ATG are given through the IV line on each of 4 consecutive days Prednisone is taken by mouth beginning the first day of ATG therapy and continuing for a total of 17 days This drug is given to reduce the side effects of ATG such as fever skin rash and chills
Cyclosporine treatment- Cyclosporine capsules are taken by mouth twice a day for at least 6 months
During hospitalization blood will be drawn daily for blood counts and other tests Upon the patients discharge after 10 days the referring physician will do blood tests weekly during the first month of treatment and then every 2 weeks for the rest of the time the patient is taking cyclosporine Dosages of this drug may be adjusted depending on the test results Patients will be evaluated at the NIH Clinical Center at 3-month intervals for the first year then every 6 months for the next 3 years and then at yearly intervals A blood sample will be drawn at each visit Bone marrow biopsies will be done at 6-month intervals for the first 3 years after treatment
A growing body of laboratory and clinical evidence suggests that the cytopenia of MDS is at least partly a result of cytotoxic T cell activity Treatments to abrogate T cell activity such as anti-thymocyte globulin alone and cyclosporine alone have demonstrated varying degrees of success in alleviating the cytopenia of MDS A response to such therapy in MDS is associated with improved survival Experience with aplastic anemia suggests that the combination of these two agents should be more effective in suppressing cytotoxic T cell activity and alleviating cytopenia This protocol proposes using the combination of antithymocyte globulin ATG and cyclosporine CSA to treat the cytopenia of MDS in an effort to improve the response rate to immunosuppressive therapy in this disease
Placement of central line-An intravenous IV catheter flexible tube inserted into a vein is placed in a large vein of the neck chest or arm Medicines are delivered through this line and blood samples are drawn from it
ATG skin testing- ATG is injected under the skin to check for sensitization to horse serum from which the drug is derived
ATG treatment-Four doses of ATG are given through the IV line on each of 4 consecutive days Prednisone is taken by mouth beginning the first day of ATG therapy and continuing for a total of 17 days This drug is given to reduce the side effects of ATG such as fever skin rash and chills
Cyclosporine treatment- Cyclosporine capsules are taken by mouth twice a day for at least 6 months
During hospitalization blood will be drawn daily for blood counts and other tests Upon the patients discharge after 10 days the referring physician will do blood tests weekly during the first month of treatment and then every 2 weeks for the rest of the time the patient is taking cyclosporine Dosages of this drug may be adjusted depending on the test results Patients will be evaluated at the NIH Clinical Center at 3-month intervals for the first year then every 6 months for the next 3 years and then at yearly intervals A blood sample will be drawn at each visit Bone marrow biopsies will be done at 6-month intervals for the first 3 years after treatment
A growing body of laboratory and clinical evidence suggests that the cytopenia of MDS is at least partly a result of cytotoxic T cell activity Treatments to abrogate T cell activity such as anti-thymocyte globulin alone and cyclosporine alone have demonstrated varying degrees of success in alleviating the cytopenia of MDS A response to such therapy in MDS is associated with improved survival Experience with aplastic anemia suggests that the combination of these two agents should be more effective in suppressing cytotoxic T cell activity and alleviating cytopenia This protocol proposes using the combination of antithymocyte globulin ATG and cyclosporine CSA to treat the cytopenia of MDS in an effort to improve the response rate to immunosuppressive therapy in this disease
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 |
|---|---|---|---|
| 00-H-0169 | OTHER | NIH NHLBI | None |