Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073931
Status:
COMPLETED
Last Update Posted:
2015-02-05
First Post:
2003-12-10
Brief Title:
Iodine I 131 Tositumomab Followed by Autologous Stem Cell Transplantation in Treating Older Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Trial Evaluating Radioiodinated Anti-B1 Anti-CD20 Antibody With Autologous Stem Cell Transplantation For Relapsed Or Refractory Non-Hodgkins Lymphoma In Patients 60 Years Of Age And Older
Status:
COMPLETED
Status Verified Date:
2015-02
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 Radiolabeled monoclonal antibodies such as iodine I 131 tositumomab can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells Combining a radiolabeled monoclonal antibody with autologous stem cell transplantation may be an effective treatment for non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with autologous stem cell transplantation in treating older patients who have relapsed or refractory non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with autologous stem cell transplantation in treating older patients who have relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the progression-free survival of older patients with relapsed or refractory non-Hodgkins lymphoma treated with iodine I 131 tositumomab followed by autologous stem cell transplantation
Secondary
Determine the overall survival of patients treated with this regimen
Determine the toxicity and tolerability of this regimen in these patients
OUTLINE
Radioimmunotherapy Patients receive a test dose of iodine I 131 tositumomab on day -24 to determine biodistribution Patients then receive therapeutic iodine I 131 tositumomab IV over 1 hour on day -14 and are entered into radiation isolation until day -4
Autologous stem cell transplantation Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0 Patients undergoing bone marrow transplantation receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously beginning on day 0 and continuing until blood counts recover
Patients are followed at 1 3 6 and 12 months and then annually thereafter
PROJECTED ACCRUAL A total of 24-30 patients will be accrued for this study within 2 years
Primary
Determine the progression-free survival of older patients with relapsed or refractory non-Hodgkins lymphoma treated with iodine I 131 tositumomab followed by autologous stem cell transplantation
Secondary
Determine the overall survival of patients treated with this regimen
Determine the toxicity and tolerability of this regimen in these patients
OUTLINE
Radioimmunotherapy Patients receive a test dose of iodine I 131 tositumomab on day -24 to determine biodistribution Patients then receive therapeutic iodine I 131 tositumomab IV over 1 hour on day -14 and are entered into radiation isolation until day -4
Autologous stem cell transplantation Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0 Patients undergoing bone marrow transplantation receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously beginning on day 0 and continuing until blood counts recover
Patients are followed at 1 3 6 and 12 months and then annually thereafter
PROJECTED ACCRUAL A total of 24-30 patients will be accrued for this study within 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 |
|---|---|---|---|
| CDR0000341125 | REGISTRY | PDQ | None |