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Trial record 6 of 23 for:    CD20 Fred Hutchinson

Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00073918
Recruitment Status : Completed
First Posted : December 11, 2003
Results First Posted : January 27, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ajay Gopal, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anaplastic Large Cell Lymphoma
Cutaneous B-cell Non-Hodgkin 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
Waldenström Macroglobulinemia
Interventions Drug: cyclophosphamide
Drug: etoposide
Radiation: iodine I 131 tositumomab
Procedure: quality-of-life assessment
Procedure: peripheral blood stem cell transplantation
Enrollment 111
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
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RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.

CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.

AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.

cyclophosphamide: Given IV

etoposide: Given IV

iodine I 131 tositumomab: Given IV

quality-of-life assessment: Ancillary study

peripheral blood stem cell transplantation: Undergo ASCT given via central catheter

Period Title: Overall Study
Started 111
Completed 107
Not Completed 4
Reason Not Completed
Eligibility requirement not met - HAMA+             1
Rapid disease progression             2
Eligibility requirement not met-low CD20             1
Arm/Group Title Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
Hide Arm/Group Description

RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.

CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.

AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.

cyclophosphamide: Given IV

etoposide: Given IV

iodine I 131 tositumomab: Given IV

quality-of-life assessment: Ancillary study

peripheral blood stem cell transplantation: Undergo ASCT given via central catheter

Overall Number of Baseline Participants 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
<=18 years
0
   0.0%
Between 18 and 65 years
111
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 111 participants
52.3
(32 to 59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Female
35
  31.5%
Male
76
  68.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Hispanic or Latino
2
   1.8%
Not Hispanic or Latino
103
  92.8%
Unknown or Not Reported
6
   5.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
American Indian or Alaska Native
1
   0.9%
Asian
6
   5.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   0.9%
White
101
  91.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
   1.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 111 participants
111
1.Primary Outcome
Title Progression-free Survival
Hide Description Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.
Time Frame At year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
Hide Arm/Group Description:

RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.

CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.

AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.

cyclophosphamide: Given IV

etoposide: Given IV

iodine I 131 tositumomab: Given IV

quality-of-life assessment: Ancillary study

peripheral blood stem cell transplantation: Undergo ASCT given via central catheter

Overall Number of Participants Analyzed 107
Measure Type: Number
Unit of Measure: percentage of participants
56
2.Secondary Outcome
Title 5 Year Overall Survival
Hide Description Survival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis.
Time Frame Up to 15 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
Hide Arm/Group Description:

RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.

CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.

AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.

cyclophosphamide: Given IV

etoposide: Given IV

iodine I 131 tositumomab: Given IV

quality-of-life assessment: Ancillary study

peripheral blood stem cell transplantation: Undergo ASCT given via central catheter

Overall Number of Participants Analyzed 107
Measure Type: Number
Unit of Measure: percentage of participants
72
3.Secondary Outcome
Title Response Rate
Hide Description Response rates will be estimated as the percentage of patients
Time Frame From date of transplant through date of relapse/progression or death, assessed up to 15 years
Hide Outcome Measure Data
Hide Analysis Population Description
Percentage of patients
Arm/Group Title Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
Hide Arm/Group Description:

RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.

CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.

AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.

cyclophosphamide: Given IV

etoposide: Given IV

iodine I 131 tositumomab: Given IV

quality-of-life assessment: Ancillary study

peripheral blood stem cell transplantation: Undergo ASCT given via central catheter

Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: percentage of participants
41.4
4.Secondary Outcome
Title Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0
Hide Description Grade 3-4 Bearman non-hematologic toxicity will be carefully monitored throughout this study. The protocol will be terminated due to safety concerns if there exists sufficient evidence suggesting that the true rate of grade 3-4 nonhematologic toxicity exceeds 25%. All patients, regardless of histology, will be evaluated together for purposes of toxicity. Sufficient evidence will be taken to be a lower limit to the appropriate 90% one-sided confidence interval in excess of 25%
Time Frame From date of first exposure to study drug, through date of relapse/progression or other significant medical event confounding further assessment, assessed up to 15 years
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Grade 3-4 toxicities.
Arm/Group Title Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
Hide Arm/Group Description:

RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.

CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.

AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.

cyclophosphamide: Given IV

etoposide: Given IV

iodine I 131 tositumomab: Given IV

quality-of-life assessment: Ancillary study

peripheral blood stem cell transplantation: Undergo ASCT given via central catheter

Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: events
9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
Hide Arm/Group Description

RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.

CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.

AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.

cyclophosphamide: Given IV

etoposide: Given IV

iodine I 131 tositumomab: Given IV

quality-of-life assessment: Ancillary study

peripheral blood stem cell transplantation: Undergo ASCT given via central catheter

All-Cause Mortality
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
Affected / at Risk (%) # Events
Total   9/107 (8.41%)    
Cardiac disorders   
cardiac left ventricular function   1/107 (0.93%)  1
Gastrointestinal disorders   
Mucositis/stomatitis   2/107 (1.87%)  2
Renal and urinary disorders   
Renal Failure   1/107 (0.93%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory distress  1/107 (0.93%)  1
Idiopathic pneumonia syndrome   1/107 (0.93%)  1
Pulmonary edema   1/107 (0.93%)  1
ARDS  [1]  1/107 (0.93%)  1
radiation pneumonitis   1/107 (0.93%)  1
Indicates events were collected by systematic assessment
[1]
Acute respiratory distress syndrome
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
Affected / at Risk (%) # Events
Total   0/107 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ajay K. Gopal, MD
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-288-2037
EMail: agopal@u.washington.edu
Layout table for additonal information
Responsible Party: Ajay Gopal, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00073918     History of Changes
Other Study ID Numbers: 1368.00
NCI-2009-01469 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P01CA044991 ( U.S. NIH Grant/Contract )
First Submitted: December 10, 2003
First Posted: December 11, 2003
Results First Submitted: December 2, 2016
Results First Posted: January 27, 2017
Last Update Posted: August 18, 2017