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Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00438880
First received: February 20, 2007
Last updated: January 4, 2016
Last verified: September 2015
Results First Received: May 20, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Non-Hodgkin Lymphoma
Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
Nodal Marginal Zone Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia
Interventions: Drug: Agatolimod Sodium
Radiation: Indium In-111 Ibritumomab Tiuxetan
Other: Laboratory Biomarker Analysis
Procedure: Radionuclide Imaging
Biological: Rituximab
Procedure: Single Photon Emission Computed Tomography
Radiation: Yttrium Y-90 Ibritumomab Tiuxetan

  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
Phase I of this study opened 10/20/2004 and accrued 30 patients before closing 10/29/2007. Eight patients were accrued to the Phase II portion at the maximum tolerated dose established in Phase I.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Phase I

Phase I patients will receive the following treatment:

  • 250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
  • 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1
  • 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
  • CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
  • 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
Phase II

Phase II patients will receive the following treatment:

  • 250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
  • 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
  • 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
  • 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15

Participant Flow:   Overall Study
    Phase I     Phase II  
STARTED     30     8  
COMPLETED     30     8  
NOT COMPLETED     0     0  



  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.
All participants accrued to this study were analyzed for baseline characteristics

Reporting Groups
  Description
Phase I

Phase I patients will receive the following treatment:

  • 250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
  • 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1
  • 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
  • CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
  • 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
Phase II

Phase II patients will receive the following treatment:

  • 250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle
  • 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8
  • 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.
  • 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
Total Total of all reporting groups

Baseline Measures
    Phase I     Phase II     Total  
Number of Participants  
[units: participants]
  30     8     38  
Age  
[units: years]
Median (Full Range)
  60.5  
  (36 to 80)  
  68.5  
  (42 to 83)  
  62.5  
  (36 to 83)  
Gender  
[units: participants]
     
Female     13     4     17  
Male     17     4     21  
Region of Enrollment  
[units: participants]
     
United States     30     8     38  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level   [ Time Frame: at least 10 weeks post treatment up to 3 months. ]

2.  Primary:   Tumor Response   [ Time Frame: Evaluations occur every three months up to a year ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Up to 1 year from treatment start date ]

4.  Secondary:   Duration of Response   [ Time Frame: Up to 1 year from treatment start date ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas E. Witzig, M.D.
Organization: Mayo Clinic Cancer Center
e-mail: witzig.thomas@mayo.edu



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00438880     History of Changes
Other Study ID Numbers: LS0382
NCI-2009-01275 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
LS0382 ( Other Identifier: Mayo Clinic )
P30CA015083 ( US NIH Grant/Contract Award Number )
Study First Received: February 20, 2007
Results First Received: May 20, 2014
Last Updated: January 4, 2016
Health Authority: United States: Food and Drug Administration