A Phase 2 interventional study of filgrastim and sargramostim in Lymphoma, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-02-05.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
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-Hodgkin's 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-Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE:
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Tumor burden less than 500 cc by computed tomography or MRI
Autologous hematopoietic stem cells or bone marrow harvested and cryopreserved
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
5 µg/kg/day subcutaneously
Also known as: G-CSF
250µg/m2/d subcutaneously
Also known as: GM-CSF
autologous stem cells given via central catheter
autologous stem cells given via central catheter
given intravenously (test dose of 1.7-10 mg/kg tositumomab antibody radiolabeled with \~10 mCi I-131) or via central catheter (therapy dose of 1.7-10 mg/kg tositumomab radiolabeled with individually calculated therapy dose of I-131)
Disease-free survival measured continuously
Time frame: from date of transplant through date of death
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Fred Hutchinson Cancer Center