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

September 8, 2017 updated by: Roswell Park Cancer Institute

Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: flow cytometry
Correlative studies
Biological: rituximab
Given IV
Other Names:
  • Rituxan
  • Mabthera
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • MOAB IDEC-C2B8
Other: immunohistochemistry staining method
Correlative studies
Other Names:
  • immunohistochemistry
Procedure: biopsy
Correlative studies
Other Names:
  • biopsies
Genetic: western blotting
Correlative studies
Other Names:
  • Blotting, Western
  • Western Blot
Biological: pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • Neulasta
  • SD-01 sustained duration G-CSF
  • GCSF-SD01

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 90 days after the last dose of study drugs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 43 weeks
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
Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
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
At 4 years
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.
Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
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.
Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
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.
Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 17, 2007

Primary Completion (Actual)

November 22, 2013

Study Completion (Actual)

December 22, 2016

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 10, 2012

Study Record Updates

Last Update Posted (Actual)

October 9, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I 83106
  • NCI-2011-00134 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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