Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005988
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2000-07-05
Brief Title:
Bone Marrow Transplantation With Specially Treated Bone Marrow in Treating Patients With Hematologic Cancer That Have Not Responded to Previous Therapy
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Open-Label Safety Study of Haploidentical Bone Marrow Transplantation BMT After Ex Vivo Treatment of Bone Marrow With Anti-B71 and Anti-B72 Antibodies
Status:
COMPLETED
Status Verified Date:
2017-03
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:
RATIONALE Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells Sometimes the transplanted cells can make an immune response against the bodys normal tissues Treatment of the donor bone marrow with the patients white blood cells and a monoclonal antibody may prevent this from happening
PURPOSE Phase I trial to study the effectiveness of bone marrow transplantation with specially treated bone marrow in treating patients who have hematologic cancer that has not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of bone marrow transplantation with specially treated bone marrow in treating patients who have hematologic cancer that has not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine if patients with refractory high risk hematologic malignancies or bone marrow failure who receive HLA haploidentical bone marrow treated with anti-B7 antibody have normal engraftment II Determine if these patients are free of hyperacute graft versus host disease GVHD defined as grade D GVHD in the first 10 posttransplant days when treated with this regimen III Determine if these patients have an acceptable incidence of life threatening grade D GHVD in the first 50 posttransplant days following this treatment regimen IV Determine the safety and tolerability of this treatment regimen in this patient population
OUTLINE This is a multicenter study Patients undergo leukapheresis to collect white blood cells which are incubated with donor bone marrow cells in the presence of anti-B71 and anti-B72 antibodies for 36 hours Patients receive total body irradiation twice daily on days -6 to -3 cyclophosphamide IV daily on days -2 and -1 and methylprednisolone IV every 12 hours for a total of 4 doses on days -2 to 0 Patients are infused with the treated donor bone marrow on day 0 Patients then receive methotrexate IV on days 1 3 6 and 11 and leucovorin calcium IV 24 hours after each dose of methotrexate every 6 hours for 3-8 doses each time Patients also receive cyclosporine IV or orally twice daily on days -2 to 100 Patients are followed every 2 months for 1 year
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
OUTLINE This is a multicenter study Patients undergo leukapheresis to collect white blood cells which are incubated with donor bone marrow cells in the presence of anti-B71 and anti-B72 antibodies for 36 hours Patients receive total body irradiation twice daily on days -6 to -3 cyclophosphamide IV daily on days -2 and -1 and methylprednisolone IV every 12 hours for a total of 4 doses on days -2 to 0 Patients are infused with the treated donor bone marrow on day 0 Patients then receive methotrexate IV on days 1 3 6 and 11 and leucovorin calcium IV 24 hours after each dose of methotrexate every 6 hours for 3-8 doses each time Patients also receive cyclosporine IV or orally twice daily on days -2 to 100 Patients are followed every 2 months for 1 year
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| CDR0000067977 | OTHER | other | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |
| GENE-C9909-38 | None | None | None |
| NCI-G00-1801 | None | None | None |