Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005803
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2000-06-02
Brief Title:
Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase III Study of Autologous Stem Cell Transplantation Followed by Nonmyeloablative Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Lymphoma - A Multi-center Trial
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:
This phase III trial studies how well autologous stem cell transplant followed by donor stem cell transplant works in treating patients with lymphoma that has returned or does not respond to treatment Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells The donated stem cells may also help destroy any remaining cancer cells graft-versus-tumor effect
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate engraftment of human leukocyte antibody HLA identical peripheral blood stem cell PBSC allografts given after conditioning with total-body irradiation TBI 200cGy - fludarabine fludarabine phosphate 90 mgm2 and post-grafting immunosuppression with cyclosporine CSPmycophenolate mofetil MMF in refractory or relapsed lymphoma patients following an initial autologous peripheral blood stem cell transplant PBSCT for disease cytoreduction
II To determine the non-relapse mortality at day 100 post-non-myeloablative allografting following mobilization and high-dose chemotherapy with autografting
SECONDARY OBJECTIVES
I To determine the disease free survival and overall survival of non-myeloablative allografting following autologous PBSCT
OUTLINE
CONDITIONING REGIMEN Patients with matched related stem cell donors receive cyclophosphamide intravenously IV on days -6 and -5 and undergo TBI twice daily BID on days -3 to -1 Patients with matched unrelated stem cell donors receive carmustine IV over 3 hours on day -7 etoposide IV over 2 hours BID on days -6 to -3 and cytarabine IV over 3 hours BID on days -6 to -3 and melphalan IV over 30 minutes on day -2
TRANSPLANTATION All patients undergo autologous PBSCT on day 0
NON-MYELOABLATIVE CONDITIONING Beginning 40-120 days following PBSC transplant patients with related donors undergo TBI on day 0 Patients with unrelated donors receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0
TRANSPLANTATION Patients undergo non-myeloablative allogeneic PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO BID on days -3 to 56 patients with related donors or 100 patients with unrelated donors followed by taper to day 180 Patients also receive mycophenolate mofetil PO BID on days 0-27 patients with related donors or thrice daily TID on days 0-27 then BID on days 28-40 followed by taper to day 96 patients with unrelated donors
Some patients may undergo donor lymphocyte infusion if there is evidence of disease progression and no evidence of graft-vs-host disease GVHD
After completion of study treatment patients are followed up at day 180 1 year 15 years 2 years 3 years and then annually thereafter
I To evaluate engraftment of human leukocyte antibody HLA identical peripheral blood stem cell PBSC allografts given after conditioning with total-body irradiation TBI 200cGy - fludarabine fludarabine phosphate 90 mgm2 and post-grafting immunosuppression with cyclosporine CSPmycophenolate mofetil MMF in refractory or relapsed lymphoma patients following an initial autologous peripheral blood stem cell transplant PBSCT for disease cytoreduction
II To determine the non-relapse mortality at day 100 post-non-myeloablative allografting following mobilization and high-dose chemotherapy with autografting
SECONDARY OBJECTIVES
I To determine the disease free survival and overall survival of non-myeloablative allografting following autologous PBSCT
OUTLINE
CONDITIONING REGIMEN Patients with matched related stem cell donors receive cyclophosphamide intravenously IV on days -6 and -5 and undergo TBI twice daily BID on days -3 to -1 Patients with matched unrelated stem cell donors receive carmustine IV over 3 hours on day -7 etoposide IV over 2 hours BID on days -6 to -3 and cytarabine IV over 3 hours BID on days -6 to -3 and melphalan IV over 30 minutes on day -2
TRANSPLANTATION All patients undergo autologous PBSCT on day 0
NON-MYELOABLATIVE CONDITIONING Beginning 40-120 days following PBSC transplant patients with related donors undergo TBI on day 0 Patients with unrelated donors receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0
TRANSPLANTATION Patients undergo non-myeloablative allogeneic PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO BID on days -3 to 56 patients with related donors or 100 patients with unrelated donors followed by taper to day 180 Patients also receive mycophenolate mofetil PO BID on days 0-27 patients with related donors or thrice daily TID on days 0-27 then BID on days 28-40 followed by taper to day 96 patients with unrelated donors
Some patients may undergo donor lymphocyte infusion if there is evidence of disease progression and no evidence of graft-vs-host disease GVHD
After completion of study treatment patients are followed up at day 180 1 year 15 years 2 years 3 years and then annually thereafter
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 |
|---|---|---|---|
| NCI-2010-00130 | REGISTRY | None | None |
| 140900 | OTHER | None | None |
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |