Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
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 Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This phase II trial studies the side effects and how well giving pegfilgrastim together with rituximab works in treating patients with untreated, relapsed, or refractory follicular lymphoma, small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL). Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of therapy. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or tumor cancer-killing substances to them. Giving pegfilgrastim together with rituximab may kill more cancer cells

Condition or disease Intervention/treatment Phase
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 Biological: pegfilgrastim Biological: rituximab Other: flow cytometry Procedure: biopsy Other: immunohistochemistry staining method Genetic: western blotting Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the safety of Pegfilgrastim in combination with rituximab in patients with untreated or relapsed/refractory follicular, SLL or MZL.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy (including overall response rate and durability of objective responses) of Pegfilgrastim in combination with rituximab in patients with untreated or relapsed/refractory follicular, SLL or MZL.

II. To evaluate functional and phenotypic characteristics of host neutrophils undergoing treatment with Pegfilgrastim and rituximab.

III. To evaluate changes in cluster of differentiation (CD)20 antigen expression and density of expression in patients receiving Pegfilgrastim and rituximab.

IV. To evaluate changes in serum levels of tumor necrosis factor (TNF), interferon alpha (INFalpha) and free radical levels in patients undergoing treatment with Pegfilgrastim and rituximab.

OUTLINE:

Patients receive pegfilgrastim subcutaneously (SC) followed by rituximab intravenously (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.

After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 2 years, and then yearly for 1 year.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma
Study Start Date : April 17, 2007
Actual Primary Completion Date : November 22, 2013
Actual Study Completion Date : December 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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.
 Biological: pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • GCSF-SD01
  • Neulasta
  • SD-01 sustained duration G-CSF

Biological: rituximab
Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan

Other: flow cytometry
Correlative studies

Procedure: biopsy
Correlative studies
Other Name: biopsies

Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry

Genetic: western blotting
Correlative studies
Other Names:
  • Blotting, Western
  • Western Blot


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 43 weeks ]
    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.

  2. 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 ]
    Mean percent change in CD11b level from baseline at each visit

  3. Percent Change in CD20 Antigen Expression and Density of Expression [ Time Frame: At 4 years ]
    Percent change in CD20 antigen expression and density of expression

  4. 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 ]
    Mean percent change in TNF level from baseline at each visit.

  5. 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 ]
    Mean percent change in INF level from baseline.

  6. 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 ]
    Mean percent change in MFI level from baseline.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Untreated or relapsed/refractory follicular, SLL or MZL (i.e. no limit to number of prior treatments as long as patients meet other study criteria)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Measurable tumor size (at least one node measuring 4 cm^2 in bidimensional measurement)
  • Expected survival of > 6 months
  • Prior rituximab or other monoclonal immunotherapy permitted and eligible for rituximab monotherapy
  • Full recovery from any significant toxicity associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy
  • Absolute neutrophil count > 1.0 x 10^9/L
  • Platelets > 50 x 10^9/L
  • Patients may receive erythropoietin growth factors to maintain adequate hemoglobin levels (>= 8.0 mg/dl)
  • Creatinine < 1.5 x upper normal levels (UNL)
  • Total bilirubin < 1.5 mg/dL (> 25.65 umol/L)
  • Aspartate aminotransferase < 5 x UNL
  • Alkaline phosphatase < 5 x UNL
  • Informed consent approved in institutional review board (lRB)
  • CD20+ B-cell lymphoma

Exclusion Criteria:

  • Prior history of human immunodeficiency virus (HIV)-positivity (routine HIV testing is required pretreatment)
  • Serious non-malignant disease (e.g. active uncontrolled bacterial, viral, or fungal infections) or other conditions which, in the opinion of the principal investigator would compromise other protocol objectives
  • Presence of central nervous system (CNS) lymphoma
  • Chemotherapy within 4 weeks of the first scheduled study treatment
  • Another primary malignancy (other than squamous or basal cell carcinoma of the skin or in-situ carcinoma of the cervix) for which the patient has not been disease-free for at least five years
  • Major surgery, other than diagnostic surgery, within four weeks
  • Patients with non-Hodgkin lymphoma (NHL) other than relapsed/refractory follicular, MZL or SLL
  • Patients must not have a history of cardiac disease, defined as New York Heart Association Class II or greater or clinical evidence of congestive heart failure
  • Concurrent use of other investigational agents
  • Pregnant or breast feeding
  • Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
  • Known hypersensitivity to any recombinant E coli-derived product, murine proteins, or any components of the study medications
  • Concerns for the subject's compliance with the protocol
  • Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g. myelodysplastic syndromes, acute or chronic myelogenous leukemia)
  • Patient is currently enrolled in, or has not yet completed at least 30 days since ending another investigational device or drug trial
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682044


Locations
Layout table for location information
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Francisco Hernandez-ILizaliturri Roswell Park Cancer Institute
  Study Documents (Full-Text)

Documents provided by Roswell Park Cancer Institute:
Study Protocol and Statistical Analysis Plan  [PDF] October 4, 2013

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Posted: September 10, 2012    Key Record Dates
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents