Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057954
Status:
TERMINATED
Last Update Posted:
2023-06-28
First Post:
2003-04-07
Brief Title:
Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkins or Hodgkins Lymphoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin and Hodgkin Lymphoma
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Photopheresis allows patient white blood cells to be treated with ultraviolet UV light and drugs outside the body to inactivate T cells Pentostatin may suppress the immune system and reduce the chance of developing graft-versus-host disease GVHD following bone marrow transplantation Combining photopheresis with pentostatin and total-body irradiation may be effective in killing cancer cells before bone marrow transplantation
PURPOSE This phase II trial is studying how well giving photophoresis together with pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone marrow transplantation works in treating patients with relapsed non-Hodgkins or Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving photophoresis together with pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone marrow transplantation works in treating patients with relapsed non-Hodgkins or Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the rate of stable engraftment of donor cells in patients with relapsed non-Hodgkins or Hodgkins lymphoma treated with a reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated bone marrow transplantation
Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the 100-day overall survival and long-term progression-free survival of patients treated with this regimen
Evaluate the feasibility of collection of molecular chimerism studies at baseline days 30 100 6 months and one and two years and at relapse
OUTLINE This is a multicenter study
Conditioning regimen Patients undergo extracorporeal photopheresis using methoxsalen and UV light on 2 consecutive days between days -7 to -4 Patients receive pentostatin intravenously IV continuously on days -3 to -2 and undergo total body irradiation on day -1
Allogeneic bone marrow transplantation Patients undergo infusion of allogeneic bone marrow or stem cells on day 0
Graft-versus-host disease prophylaxis Patients receive oral or IV cyclosporine beginning on day -1 and continuing until 6 months after transplantation oral mycofenolate mofetil beginning on day 100 and continuing for 1 year and methotrexate IV on days 1 and 3
Patients are followed at day 100 every 3 months for 1 year every 6 months for 2 years and then annually for 2 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 18 years
Determine the rate of stable engraftment of donor cells in patients with relapsed non-Hodgkins or Hodgkins lymphoma treated with a reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated bone marrow transplantation
Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the 100-day overall survival and long-term progression-free survival of patients treated with this regimen
Evaluate the feasibility of collection of molecular chimerism studies at baseline days 30 100 6 months and one and two years and at relapse
OUTLINE This is a multicenter study
Conditioning regimen Patients undergo extracorporeal photopheresis using methoxsalen and UV light on 2 consecutive days between days -7 to -4 Patients receive pentostatin intravenously IV continuously on days -3 to -2 and undergo total body irradiation on day -1
Allogeneic bone marrow transplantation Patients undergo infusion of allogeneic bone marrow or stem cells on day 0
Graft-versus-host disease prophylaxis Patients receive oral or IV cyclosporine beginning on day -1 and continuing until 6 months after transplantation oral mycofenolate mofetil beginning on day 100 and continuing for 1 year and methotrexate IV on days 1 and 3
Patients are followed at day 100 every 3 months for 1 year every 6 months for 2 years and then annually for 2 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| E1402 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |