Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004904
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2000-03-07
Brief Title:
Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase I Study of T Cell Depleted TCD Partially Matched Related Donor PMRD Hematopoietic Stem Cell Transplantation for High Risk Hematologic Diseases Using Intense Pre and Post Transplant Immunosuppression and Megadose CD34 Veto Cells
Status:
COMPLETED
Status Verified Date:
2012-05
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 Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of treated donor stem cell transplantation in treating patients who have hematologic cancer
PURPOSE Phase I trial to study the effectiveness of treated donor stem cell transplantation in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES I Determine if megadose CD34 cells and intense immunosuppression administered before and after partially matched related donor PMRD hematopoietic stem cell HSC transplantation results in engraftment in patients with high risk hematologic malignancies II Determine the incidence and severity of acute grade I-IV and chronic limited or extensive graft versus host disease in patients after rigorous T-cell depletion in PMRD HSC transplantation
OUTLINE Harvest Bone marrow and peripheral blood stem cells PBSC are harvested from a related 1 2 or 3 HLA antigen mismatched donor PBSC are selected for CD34 cells and T-cells are depleted Conditioning Patients undergo total body irradiation twice daily on days -10 to -7 and once on day -6 Patients receive cladribine IV continuously on days -10 to -6 etoposide IV over 2 hours on day -5 and cyclophosphamide IV over 2 hours antithymocyte globulin ATG IV over 10-12 hours and methylprednisolone IV over 1 hour on days -4 to -2 Transplantation T-cell depleted PBSC and bone marrow are infused on day 0 Patients receive G-CSF SQ daily beginning on day 0 and continuing until blood counts recover Graft versus host disease prophylaxis Patients receive tacrolimus IV every 12 hours beginning on day -2 and continuing orally 4 times a day for 6-12 months at the discretion of the protocol investigator Patients receive ATG IV over 10-12 hours and methylprednisolone IV over 1 hour on days 5-15 followed by a taper of methylprednisolone Patients are followed every week through day 100 and then at 6 and 12 months
PROJECTED ACCRUAL A total of 12-20 patients will be accrued for this study within 3 years
OUTLINE Harvest Bone marrow and peripheral blood stem cells PBSC are harvested from a related 1 2 or 3 HLA antigen mismatched donor PBSC are selected for CD34 cells and T-cells are depleted Conditioning Patients undergo total body irradiation twice daily on days -10 to -7 and once on day -6 Patients receive cladribine IV continuously on days -10 to -6 etoposide IV over 2 hours on day -5 and cyclophosphamide IV over 2 hours antithymocyte globulin ATG IV over 10-12 hours and methylprednisolone IV over 1 hour on days -4 to -2 Transplantation T-cell depleted PBSC and bone marrow are infused on day 0 Patients receive G-CSF SQ daily beginning on day 0 and continuing until blood counts recover Graft versus host disease prophylaxis Patients receive tacrolimus IV every 12 hours beginning on day -2 and continuing orally 4 times a day for 6-12 months at the discretion of the protocol investigator Patients receive ATG IV over 10-12 hours and methylprednisolone IV over 1 hour on days 5-15 followed by a taper of methylprednisolone Patients are followed every week through day 100 and then at 6 and 12 months
PROJECTED ACCRUAL A total of 12-20 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| NU-97H1 | None | None | None |
| NCI-G00-1691 | None | None | None |