Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098566
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2004-12-07
Brief Title:
Long-Term Effects of Iodine I Tositumomab and Autologous Bone Marrow or Stem Cell Transplantation in Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Long-Term Follow-Up Study Evaluating the Efficacy and Delayed Toxicities of Radioiodinated Tositumomab Anti-CD20 Antibody Followed by Autologous Transplantation for Relapsed or Refractory Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-10
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 Studying the long-term effects of cancer treatment in cancer survivors may help improve the ability to plan effective treatment and follow-up care
PURPOSE This phase II trial is studying the long-term effects of iodine I 131 tositumomab and autologous bone marrow or stem cell transplantation in patients with relapsed or refractory non-Hodgkins lymphoma
PURPOSE This phase II trial is studying the long-term effects of iodine I 131 tositumomab and autologous bone marrow or stem cell transplantation in patients with relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the progression-free survival and overall survival of patients with relapsed or refractory B-cell non-Hodgkins lymphoma previously treated with iodine I131 tositumomab followed by autologous bone marrow or stem cell transplantation on FHCRC protocols 296 521 792 or 915
Determine the long-term toxic effects of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a long-term follow-up study
Patients undergo testing for human anti-mouse antibody at 1 3 and 12 months Patients undergo physical examinations blood tests and immune system assessments every 3 months for 1 year and then annually thereafter Thyroid pulmonary and cardiac function are assessed at 1 year and then annually as needed Patients also undergo CT scans and bone marrow biopsy if clinically indicated annually for up to 10 years
Quality of life is assessed annually
PROJECTED ACCRUAL A total of 47 patients will be accrued for this study
Determine the progression-free survival and overall survival of patients with relapsed or refractory B-cell non-Hodgkins lymphoma previously treated with iodine I131 tositumomab followed by autologous bone marrow or stem cell transplantation on FHCRC protocols 296 521 792 or 915
Determine the long-term toxic effects of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a long-term follow-up study
Patients undergo testing for human anti-mouse antibody at 1 3 and 12 months Patients undergo physical examinations blood tests and immune system assessments every 3 months for 1 year and then annually thereafter Thyroid pulmonary and cardiac function are assessed at 1 year and then annually as needed Patients also undergo CT scans and bone marrow biopsy if clinically indicated annually for up to 10 years
Quality of life is assessed annually
PROJECTED ACCRUAL A total of 47 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000398806 | REGISTRY | PDQ | None |
| FHCRC-173400 | None | None | None |