Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005854
Status:
COMPLETED
Last Update Posted:
2011-11-30
First Post:
2000-06-02
Brief Title:
Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Transplantation of HLA Haploidentical Marrow Cells After Ex Vivo Exposure to Recipient Alloantigen in Presence of CTLA4-Ig - A Phase II Study of Tolerance Induction in Donor T Cells by Blockade of the CD80CD86CD28 Costimulatory Signal
Status:
COMPLETED
Status Verified Date:
2011-11
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 and radiation therapy used to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation in treating patients who have hematologic cancer
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES I Determine the incidence and severity of acute graft versus host disease after transplantation of HLA haploidentical bone marrow preincubated with alloantigen and CTLA4-Ig ex vivo in patients with hematologic malignancies II Determine the engraftment rate with this treatment regimen in these patients III Determine the safety of this treatment regimen in these patients IV Determine the incidence of infection and relapse after this treatment regimen in these patients V Determine whether host specific tolerance develops in these patients after receiving this treatment regimen
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 CTLA4-Ig for 36 hours Patients undergo total body irradiation on days -7 -6 -5 and -4 and receive cyclophosphamide IV on days -3 and -2 Patients with acute lymphocytic leukemia prior lymphoid blast crisis chronic myelogenous leukemia high grade non-Hodgkins leukemia NHL intermediate grade NHL with prior marrow or extramedullary disease or prior CNS leukemia receive 2 doses of methotrexate intrathecally prior to bone marrow transplantation and 4-6 doses following Patients receive bone marrow transplantation on day 0 methotrexate IV on days 1 3 6 and 11 and cyclosporine IV on days -1 to 50 Patients are followed weekly for 1 month monthly for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 1-2 years
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 CTLA4-Ig for 36 hours Patients undergo total body irradiation on days -7 -6 -5 and -4 and receive cyclophosphamide IV on days -3 and -2 Patients with acute lymphocytic leukemia prior lymphoid blast crisis chronic myelogenous leukemia high grade non-Hodgkins leukemia NHL intermediate grade NHL with prior marrow or extramedullary disease or prior CNS leukemia receive 2 doses of methotrexate intrathecally prior to bone marrow transplantation and 4-6 doses following Patients receive bone marrow transplantation on day 0 methotrexate IV on days 1 3 6 and 11 and cyclosporine IV on days -1 to 50 Patients are followed weekly for 1 month monthly for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 1-2 years
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 |
|---|---|---|---|
| CDR0000067879 | REGISTRY | PDQ | None |
| FHCRC-145700 | None | None | None |
| NCI-H00-0059 | None | None | None |