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Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01682044
First Posted: September 10, 2012
Last Update Posted: October 9, 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):
Roswell Park Cancer Institute
Results First Submitted: June 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Contiguous Stage II Marginal Zone Lymphoma
Contiguous Stage II Small Lymphocytic Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Marginal Zone Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Stage I Grade 1 Follicular Lymphoma
Stage I Grade 2 Follicular Lymphoma
Stage I Grade 3 Follicular Lymphoma
Stage I Marginal Zone Lymphoma
Stage I Small Lymphocytic Lymphoma
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Stage III Marginal Zone Lymphoma
Stage III Small Lymphocytic Lymphoma
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Stage IV Marginal Zone Lymphoma
Stage IV Small Lymphocytic Lymphoma
Interventions: Biological: pegfilgrastim
Biological: rituximab
Other: flow cytometry
Procedure: biopsy
Other: immunohistochemistry staining method
Genetic: western blotting

  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
No text entered.

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
Treatment (Colony-stimulating Factor and Monoclonal Antibody)

Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.

pegfilgrastim: Given SC

rituximab: Given IV

flow cytometry: Correlative studies

biopsy: Correlative studies

immunohistochemistry staining method: Correlative studies

western blotting: Correlative studies


Participant Flow:   Overall Study
    Treatment (Colony-stimulating Factor and Monoclonal Antibody)
STARTED   20 
COMPLETED   16 
NOT COMPLETED   4 
Death                1 
Progression                3 



  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 treated and eligible patients

Reporting Groups
  Description
Treatment (Colony-stimulating Factor and Monoclonal Antibody)

Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.

pegfilgrastim: Given SC

rituximab: Given IV

flow cytometry: Correlative studies

biopsy: Correlative studies

immunohistochemistry staining method: Correlative studies

western blotting: Correlative studies


Baseline Measures
   Treatment (Colony-stimulating Factor and Monoclonal Antibody) 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.9  (13.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  30.0% 
Male      14  70.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: Up to 90 days after the last dose of study drugs ]

2.  Secondary:   Overall Response Rate   [ Time Frame: Up to 43 weeks ]

3.  Secondary:   Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline   [ Time Frame: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39 ]

4.  Secondary:   Percent Change in CD20 Antigen Expression and Density of Expression   [ Time Frame: At 4 years ]

5.  Secondary:   Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline   [ Time Frame: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39 ]

6.  Secondary:   Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline   [ Time Frame: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39 ]

7.  Secondary:   Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline   [ Time Frame: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39 ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01682044     History of Changes
Obsolete Identifiers: NCT00524628
Other Study ID Numbers: I 83106
NCI-2011-00134 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: September 5, 2012
First Posted: September 10, 2012
Results First Submitted: June 14, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017