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

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ClinicalTrials.gov Identifier: NCT01682044
Recruitment Status : Completed
First Posted : September 10, 2012
Results First Posted : October 9, 2017
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   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
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 20
Completed 16
Not Completed 4
Reason Not Completed
Death             1
Progression             3
Arm/Group Title Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
60.9  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
6
  30.0%
Male
14
  70.0%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE
Time Frame Up to 90 days after the last dose of study drugs
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
3
  15.0%
Grade 2
9
  45.0%
Grade 3
6
  30.0%
Grade 4
1
   5.0%
Grade 5
1
   5.0%
2.Secondary Outcome
Title Overall Response Rate
Hide Description Overall Response is defined as Complete Response: During observation, no disease is apparent, including measurable and non-measurable disease, and no evidence of disease is observed for at least 28 days, as confirmed by a second assessment following the original observation of no disease; and Partial Response: A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the 50% or greater decrease, and no appearance of new lesions is noted.
Time Frame Up to 43 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60
(38.7 to 78.1)
3.Secondary Outcome
Title Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
Hide Description Mean percent change in CD11b level from baseline at each visit
Time Frame Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
week 1 -20.2  (34.0)
week 3 -35.5  (28.3)
week 5 -24.7  (117.7)
week 7 -56.8  (27.4)
week 15 -23.8  (40.1)
week 23 -19.7  (35.7)
week 31 -18.7  (47.0)
week 39 -10.1  (42.7)
4.Secondary Outcome
Title Percent Change in CD20 Antigen Expression and Density of Expression
Hide Description Percent change in CD20 antigen expression and density of expression
Time Frame At 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Samples tissues were not large enough to perform analysis. No participants were analyze.
Arm/Group Title Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
Hide Description Mean percent change in TNF level from baseline at each visit.
Time Frame Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
week 1 51.5  (65.1)
week 3 14.5  (47.7)
week 5 11.2  (50.1)
week 7 8.3  (34.2)
week 15 42.7  (76.4)
week 23 27.2  (80.6)
week 31 45.6  (100.5)
week 39 50.2  (110.6)
6.Secondary Outcome
Title Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
Hide Description Mean percent change in INF level from baseline.
Time Frame Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
week 1 -18.8  (33.2)
week 3 -27.8  (42.9)
week 5 48.1  (124.6)
week 7 8.0  (71.4)
week 15 1.5  (78.6)
week 23 -14.1  (43.9)
week 31 -33.0  (49.5)
week 39 -7.5  (45.1)
7.Secondary Outcome
Title Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
Hide Description Mean percent change in MFI level from baseline.
Time Frame Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
week 1 -32.0  (66.8)
week 3 -22.4  (71.0)
week 5 -45.4  (66.5)
week 7 -20.4  (89.9)
week 15 -5.8  (137.6)
week 23 0.4  (219.1)
week 31 295.8  (996.1)
week 39 16.0  (285.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Affected / at Risk (%) # Events
Total   2/20 (10.00%)    
Cardiac disorders   
Coronary artery occlusion   1/20 (5.00%)  1
Sinus tachycardia   1/20 (5.00%)  1
Ventricular arrhythmia   1/20 (5.00%)  1
Ear and labyrinth disorders   
Vertigo   1/20 (5.00%)  1
General disorders   
Death   1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Affected / at Risk (%) # Events
Total   20/20 (100.00%)    
Blood and lymphatic system disorders   
Anaemia   11/20 (55.00%)  15
Leukopenia   4/20 (20.00%)  11
Lymphopenia   8/20 (40.00%)  25
Neutropenia   2/20 (10.00%)  5
Thrombocytopenia   7/20 (35.00%)  14
Cardiac disorders   
Supraventricular extrasystoles   1/20 (5.00%)  1
Tachycardia   1/20 (5.00%)  1
Ear and labyrinth disorders   
Ear discomfort   1/20 (5.00%)  1
Eye disorders   
Diplopia   1/20 (5.00%)  1
Lacrimation increased   1/20 (5.00%)  1
Vitreous floaters   1/20 (5.00%)  1
Gastrointestinal disorders   
Abdominal discomfort   1/20 (5.00%)  1
Abdominal pain   2/20 (10.00%)  2
Constipation   2/20 (10.00%)  2
Diarrhoea   2/20 (10.00%)  3
Gastrooesophageal reflux disease   1/20 (5.00%)  1
Hiatus hernia   1/20 (5.00%)  1
Intestinal mass   1/20 (5.00%)  1
Nausea   7/20 (35.00%)  10
Vomiting   4/20 (20.00%)  5
General disorders   
Asthenia   2/20 (10.00%)  2
Chills   6/20 (30.00%)  8
Discomfort   1/20 (5.00%)  1
Fatigue   4/20 (20.00%)  6
Infusion site pain   1/20 (5.00%)  1
Malaise   1/20 (5.00%)  1
Oedema peripheral   1/20 (5.00%)  1
Pain   4/20 (20.00%)  4
Pyrexia   2/20 (10.00%)  2
Sensation of foreign body   1/20 (5.00%)  1
Hepatobiliary disorders   
Hyperbilirubinaemia   1/20 (5.00%)  1
Immune system disorders   
Cytokine release syndrome   6/20 (30.00%)  6
Infections and infestations   
Cellulitis   1/20 (5.00%)  1
Influenza   1/20 (5.00%)  1
Nasopharyngitis   1/20 (5.00%)  1
Respiratory tract infection   3/20 (15.00%)  3
Sinusitis   1/20 (5.00%)  1
Upper respiratory tract infection   1/20 (5.00%)  1
Injury, poisoning and procedural complications   
Procedural pain   1/20 (5.00%)  1
Investigations   
Alanine aminotransferase increased   1/20 (5.00%)  1
Aspartate aminotransferase increased   3/20 (15.00%)  4
Blood albumin   1/20 (5.00%)  1
Blood alkaline phosphatase   15/20 (75.00%)  52
Blood alkaline phosphatase increased   3/20 (15.00%)  5
Blood creatine   1/20 (5.00%)  1
Blood creatinine   2/20 (10.00%)  2
Blood creatinine increased   1/20 (5.00%)  3
Blood glucose   1/20 (5.00%)  1
Blood glucose decreased   1/20 (5.00%)  2
Blood potassium decreased   1/20 (5.00%)  2
Blood sodium   2/20 (10.00%)  2
Blood sodium decreased   1/20 (5.00%)  1
Blood sodium increased   1/20 (5.00%)  1
Blood uric acid increased   4/20 (20.00%)  10
Body temperature increased   2/20 (10.00%)  2
Haemoglobin decreased   1/20 (5.00%)  1
Heart rate increased   2/20 (10.00%)  2
Weight decreased   3/20 (15.00%)  3
Weight increased   1/20 (5.00%)  1
Metabolism and nutrition disorders   
Hyperalbuminaemia   1/20 (5.00%)  2
Hypercalcaemia   1/20 (5.00%)  3
Hyperglycaemia   5/20 (25.00%)  7
Hyperkalaemia   3/20 (15.00%)  4
Hypernatraemia   4/20 (20.00%)  4
Hyperphosphataemia   3/20 (15.00%)  4
Hyperuricaemia   6/20 (30.00%)  11
Hypoalbuminaemia   1/20 (5.00%)  1
Hypoglycaemia   1/20 (5.00%)  1
Hypokalaemia   1/20 (5.00%)  2
Hyponatraemia   3/20 (15.00%)  3
Hypophosphataemia   3/20 (15.00%)  8
Musculoskeletal and connective tissue disorders   
Back pain   2/20 (10.00%)  5
Bone pain   11/20 (55.00%)  17
Flank pain   1/20 (5.00%)  1
Muscular weakness   1/20 (5.00%)  1
Musculoskeletal discomfort   1/20 (5.00%)  1
Pain in extremity   1/20 (5.00%)  1
Nervous system disorders   
Burning sensation mucosal   1/20 (5.00%)  3
Dizziness   2/20 (10.00%)  3
Headache   4/20 (20.00%)  5
Psychiatric disorders   
Anorexia nervosa   1/20 (5.00%)  1
Anxiety   1/20 (5.00%)  1
Nervousness   1/20 (5.00%)  1
Renal and urinary disorders   
Bladder discomfort   1/20 (5.00%)  1
Dysuria   1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough   5/20 (25.00%)  5
Dyspnoea   1/20 (5.00%)  1
Dyspnoea exertional   3/20 (15.00%)  3
Oropharyngeal pain   1/20 (5.00%)  1
Rhinorrhoea   1/20 (5.00%)  1
Sinus congestion   1/20 (5.00%)  1
Skin and subcutaneous tissue disorders   
Acne   1/20 (5.00%)  1
Cold sweat   1/20 (5.00%)  1
Dry skin   1/20 (5.00%)  1
Hyperhidrosis   2/20 (10.00%)  2
Night sweats   2/20 (10.00%)  3
Pruritus   1/20 (5.00%)  4
Vascular disorders   
Flushing   1/20 (5.00%)  1
Hypertension   2/20 (10.00%)  2
Pallor   1/20 (5.00%)  1
Indicates events were collected by systematic assessment
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: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01682044    
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