Iodine I 131 Tositumomab and Fludarabine Phosphate in Treating Older Patients Who Are Undergoing an Autologous or Syngeneic Stem Cell Transplant for Relapsed or Refractory Non-Hodgkin's Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Splenic Marginal Zone Lymphoma
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
Radiation: iodine I 131 tositumomab
Other: laboratory biomarker analysis
Other: flow cytometry
Genetic: polymerase chain reaction
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Clinical Trial Evaluating I131-Tositumomab (Anti-CD20) With Escalating Doses of Fludarabine Followed by Autologous or Syngeneic Stem Cell Transplantation for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma in Patients 60 Years of Age and Older|
- Maximum tolerated dose/dose limiting toxicity [ Time Frame: Up to 30 days post-transplant ] [ Designated as safety issue: Yes ]Assessed according to Bearman scale for Regimen-Related Toxicities.
- Overall and progression-free survival rate [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Toxicity/tolerability of study regimen [ Time Frame: Through day 100 post-transplant ] [ Designated as safety issue: Yes ]Type, frequency, and severity of adverse events grade 3 and above (assessed by National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v3.0.
- Feasibility of concurrent high-dose radioimmunotherapy and chemotherapy [ Time Frame: Through day -7 prior to transplant ] [ Designated as safety issue: No ]Ability to administer complete course of I 131-tositumomab and fludarabine phosphate as descried in protocol.
|Study Start Date:||January 2005|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemoradioimmunotherapy)
Patients receive a dosimetric dose of iodine I 131 tositumomab IV over 40-60 minutes on day -24 followed by gamma camera imaging over the next 6 days. Patients then receive a therapeutic dose of iodine I 131 tositumomab via central line over 40-60 minutes on day -14. Patients also receive fludarabine phosphate IV QD on days -11 to -9 OR days -11 or -7. Patients undergo autologous or syngeneic peripheral blood stem cell transplantation on day 0.
Drug: fludarabine phosphate
Other Names:Procedure: peripheral blood stem cell transplantation
Undergo transplantation (infusion of autologous or syngeneic PBSC via central line)
Other Names:Radiation: iodine I 131 tositumomab
Given IV (dosimetric dose) or via central line (therapeutic dose)
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: flow cytometry
Correlative studiesGenetic: polymerase chain reaction
Other Name: PCR
I. To estimate the maximally tolerated dose of fludarabine that can be combined with 131I-anti-CD20 (iodine I 131 tositumomab) delivering =< 27Gy to critical normal organs followed by autologous or syngeneic transplantation in patients >= 60 years of age with relapsed B-NHL.
I. To assess the overall and progression-free survival of the above regimen in such patients.
II. To evaluate the response rates of the above therapy.
III. To evaluate the toxicity and tolerability of the above therapy.
IV. To evaluate the feasibility of delivering concurrent high-dose radioimmunotherapy (RIT) and chemotherapy.
OUTLINE: This is a dose-escalation study of fludarabine phosphate as used in combination with I 131 tositumomab and stem cell transplant.
Patients receive a dosimetric dose of iodine I 131 tositumomab intravenously (IV) over 40-60 minutes on day -24 followed by gamma camera imaging over the next 6 days. Patients then receive a therapeutic dose of iodine I 131 tositumomab via central line over 40-60 minutes on day -14. Patients also receive fludarabine phosphate IV once daily (QD) on days -11 to -9 OR days -11 or -7. Patients undergo autologous or syngeneic peripheral blood stem cell transplantation on day 0.
Patients with circulating lymphoma cells by peripheral smear receive tositumomab IV over 1 hour OR rituximab IV over 1 hour followed by tositumomab IV over 1 hour before the dosimetric iodine I 131 tositumomab infusion.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110071
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Ajay Gopal||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|