Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040417
Status:
TERMINATED
Last Update Posted:
2020-01-18
First Post:
2002-06-26
Brief Title:
Bone Marrow Transplant From Donor Using Less Toxic Conditioning for Patient With High Risk Hemoglobinopathies
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Allo SCT From HLA Haploidentical Related Donors Using Sub-Myeloablative Conditioning For Patients With High Risk Hemoglobinopathies Hemo SS Hemo SC Hemo SB0 Thalassemia Homozygous B0 Thalassemia or Severe B0 Thalassemia Variants
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to accrue patients
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The major goal of this study is to determine the risks and benefits of stem cell transplants in combination with a newer less toxic conditioning chemotherapy treatment in patients with severe sickle cell disease SCD or sickle hemoglobin variants hemoglobin SC or hemoglobin SB0 or homozygous b0 thalassemia or severe B0 thalassemia variants Participation in this project will be for one year with follow up evaluations done every 6 months thereafter for 10 years or until participants are 18 years old
Detailed Description:
To do the stem cell transplant we must first kill most of the cells in the bone marrow that make the sickle hemoglobin or abnormal blood cells of severe beta thalassemia We will do this by using a single dose of body irradiation and two drugs called Fludarabine and Campath-IH
The treatment schedule is as follows
Day - 6 Total body irradiation Day - 5 Fludarabine and Campath 1H Day - 4 Fludarabine and Campath 1H Day - 3 Fludarabine and Campath 1H Day - 2 Fludarabine and Campath 1H Day - 1 REST Day 0 Stem Cell Transplant infusion
After the drug treatment participants will be given healthy stem cells from a related donor that partially matches their HLA immune type most likely from a parent or sibling This is known as the stem cell transplant
The healthy stem cells will be put into a blood vein in the same way that transfusions are given The cells then travel to the right places in the body where they should grow and make new blood cells that do not sickle
The treatment schedule is as follows
Day - 6 Total body irradiation Day - 5 Fludarabine and Campath 1H Day - 4 Fludarabine and Campath 1H Day - 3 Fludarabine and Campath 1H Day - 2 Fludarabine and Campath 1H Day - 1 REST Day 0 Stem Cell Transplant infusion
After the drug treatment participants will be given healthy stem cells from a related donor that partially matches their HLA immune type most likely from a parent or sibling This is known as the stem cell transplant
The healthy stem cells will be put into a blood vein in the same way that transfusions are given The cells then travel to the right places in the body where they should grow and make new blood cells that do not sickle
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 |
|---|---|---|---|
| Smallo | None | None | None |