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Tositumomab and Iodine I 131 Tositumomab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00476047
First Posted: May 21, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mazyar Shadman, Fred Hutchinson Cancer Research Center
Results First Submitted: April 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lymphoid Leukemia in Remission
Stage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage III Small Lymphocytic Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage IV Small Lymphocytic Lymphoma
Intervention: Combination Product: Tositumomab and Iodine I 131 Tositumomab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (Monoclonal Antibody Therapy)

Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.

Tositumomab and Iodine I 131 Tositumomab: Give IV

Laboratory Biomarker Analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Monoclonal Antibody Therapy)
STARTED   16 
Completed Treatment   16 
COMPLETED   15 
NOT COMPLETED   1 
Lost to Follow-up                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Treatment (Monoclonal Antibody Therapy)

Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.

Tositumomab and Iodine I 131 Tositumomab: Give IV

Laboratory Biomarker Analysis: Correlative studies


Baseline Measures
   Treatment (Monoclonal Antibody Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Years]
Mean (Full Range)
 61 
 (38 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  31.3% 
Male      11  68.8% 
CLL or SLL 
[Units: Participants]
Count of Participants
 
CLL (Chronic lymphocytic leukemia)      11  68.8% 
SLL (Small lymphocytic leukemia)      5  31.3% 
Prior chemotherapy 
[Units: Participants]
Count of Participants
 
FR (fludaribine and rituximab)      9  56.3% 
FCR(fludaribine, cyclophosphamide and rituximab)      4  25.0% 
BR (bendamustine and rituximab)      2  12.5% 
R-CHOP      1   6.3% 
Disease status before 131 I-tositumomab [1] 
[Units: Participants]
Count of Participants
 
CR (complete response)      4  25.0% 
PR (partial response)      12  75.0% 
[1]

CRITERIA FOR RESPONSE Criteria for response are specified by the NCI working group guidelines; in addition, patients will be required to meet computed tomography (CT) scan criteria as defined in the protocol.

Complete response (CR) Partial response (PR) Progressive Disease (PD) Stable Disease (SD)

Minimal Residual Disease (MRD) status before 131 I-tositumomab [1] 
[Units: Participants]
Count of Participants
 
Positive      12  75.0% 
Negative      4  25.0% 
[1] MRD was assessed on bone marrow samples using 8 color flow cytometry to detect CLL/SLL cells. Any level of residual disease by flow cytometry or cytogenetics was considered MRD positive. Negativity of both tests was required to classify a patient as MRD negative.


  Outcome Measures
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1.  Primary:   Probability of Progression-free Survival (PFS)   [ Time Frame: 36 months ]

2.  Primary:   Improved Response Rate After Treatment With 131I-tositumomab for Patients Who Had Evidence of CLL at the End of Initial Chemotherapy   [ Time Frame: 3 months after 131I-tositumomab consolidation ]

3.  Primary:   Minimal Residual Disease (MRD) by Flow Cytometry or Polymerase Chain Reaction (PCR) in Patients Who Had a Complete Remission (CR) After Any Prior Therapy   [ Time Frame: 3 months after 131I-tositumomab consolidation ]

4.  Secondary:   Evaluate Toxicities of 131I-tositumomab   [ Time Frame: 48 months (median) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mazyar Shadman, MD
Organization: Fred Hutchinson Cancer Research Ctr
phone: 2066675467
e-mail: mshadman@fredhutch.org



Responsible Party: Mazyar Shadman, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00476047     History of Changes
Other Study ID Numbers: PSOC 2301
NCI-2011-01311 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PSOC 2301 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: May 17, 2007
First Posted: May 21, 2007
Results First Submitted: April 14, 2017
Results First Posted: October 12, 2017
Last Update Posted: October 12, 2017