Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053989
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2003-02-05
Brief Title:
NMA Allogeneic Hematopoietic Cell Transplant in Hematologic CancerDisorders
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders
Status:
COMPLETED
Status Verified Date:
2019-12
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 Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells It also stops the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune system and help destroy any remaining cancer cells graft-versus-tumor effect Giving an infusion of the donors T cells donor lymphocyte infusion after the transplant may help increase this effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving immunosuppressive therapy before or after the transplant may stop this from happening
PURPOSE This phase II trial is studying how well chemotherapy followed by donor peripheral stem cell transplant works in treating patients with hematologic cancer or aplastic anemia
PURPOSE This phase II trial is studying how well chemotherapy followed by donor peripheral stem cell transplant works in treating patients with hematologic cancer or aplastic anemia
Detailed Description:
OBJECTIVES
Determine the safety and toxic effects of nonmyeloablative allogeneic peripheral blood stem cell transplantation in patients with a hematologic malignancy or aplastic anemia
Determine clinical response and overall outcome of patients treated with this regimen
Determine the incidence of graft-vs-tumor effect graft-vs-host disease and chimerism in patients treated with this regimen
OUTLINE
Preparative regimen
Matched related and unrelated donor transplantation
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine IV over 30 minutes on days -5 to -1
Cord blood transplantation
Patients receive the same regimen as above plus anti-thymocyte globulin IV over 4 hours on days -3 to -1
Graft-vs-host disease GVHD prophylaxis
Matched related and unrelated donor transplantation
Patients receive oral tacrolimus or IV once daily and oral mycophenolate mofetil MMF or IV twice daily on days -1 to 60 followed by tapering of this regimen Patients then receive methotrexate IV on days 1 3 and 6
Cord blood transplantation
Patients receive tacrolimus and MMF in the same regimen as above plus methylprednisolone twice daily on days 1-19 or until blood counts recover
Allogeneic stem cell reinfusion Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0 Patients then receive sargramostim GM-CSF subcutaneously daily beginning on day 7 and continuing until blood counts recover
Donor lymphocyte infusion DLI Patients not converting to 100 donor T-cell chimerism by day 120 and showing signs of progresson of disease after tacrolimus and MMF withdrawal may receive DLI every 8 weeks for up to 3 infusions Cord blood recipients do not receive DLI
Patients are followed at day 100-120 every 3 months for 2 years and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 30-60 patients will be accrued for this study within 6-7 years
Determine the safety and toxic effects of nonmyeloablative allogeneic peripheral blood stem cell transplantation in patients with a hematologic malignancy or aplastic anemia
Determine clinical response and overall outcome of patients treated with this regimen
Determine the incidence of graft-vs-tumor effect graft-vs-host disease and chimerism in patients treated with this regimen
OUTLINE
Preparative regimen
Matched related and unrelated donor transplantation
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine IV over 30 minutes on days -5 to -1
Cord blood transplantation
Patients receive the same regimen as above plus anti-thymocyte globulin IV over 4 hours on days -3 to -1
Graft-vs-host disease GVHD prophylaxis
Matched related and unrelated donor transplantation
Patients receive oral tacrolimus or IV once daily and oral mycophenolate mofetil MMF or IV twice daily on days -1 to 60 followed by tapering of this regimen Patients then receive methotrexate IV on days 1 3 and 6
Cord blood transplantation
Patients receive tacrolimus and MMF in the same regimen as above plus methylprednisolone twice daily on days 1-19 or until blood counts recover
Allogeneic stem cell reinfusion Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0 Patients then receive sargramostim GM-CSF subcutaneously daily beginning on day 7 and continuing until blood counts recover
Donor lymphocyte infusion DLI Patients not converting to 100 donor T-cell chimerism by day 120 and showing signs of progresson of disease after tacrolimus and MMF withdrawal may receive DLI every 8 weeks for up to 3 infusions Cord blood recipients do not receive DLI
Patients are followed at day 100-120 every 3 months for 2 years and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 30-60 patients will be accrued for this study within 6-7 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 |
|---|---|---|---|
| RP01-05 | None | None | None |