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

Primary Purpose

Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Grade 3 Follicular Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pegfilgrastim
rituximab
flow cytometry
biopsy
immunohistochemistry staining method
western blotting
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contiguous Stage II Grade 1 Follicular Lymphoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (colony-stimulating factor and monoclonal antibody)

Arm 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.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
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

Overall Response Rate
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.
Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
Mean percent change in CD11b level from baseline at each visit
Percent Change in CD20 Antigen Expression and Density of Expression
Percent change in CD20 antigen expression and density of expression
Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
Mean percent change in TNF level from baseline at each visit.
Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
Mean percent change in INF level from baseline.
Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
Mean percent change in MFI level from baseline.

Full Information

First Posted
September 5, 2012
Last Updated
September 8, 2017
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01682044
Brief Title
Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma
Official Title
Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 17, 2007 (undefined)
Primary Completion Date
November 22, 2013 (Actual)
Study Completion Date
December 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (colony-stimulating factor and monoclonal antibody)
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
pegfilgrastim
Other Intervention Name(s)
Filgrastim SD-01, GCSF-SD01, Neulasta, SD-01 sustained duration G-CSF
Intervention Description
Given SC
Intervention Type
Biological
Intervention Name(s)
rituximab
Other Intervention Name(s)
IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
biopsy
Other Intervention Name(s)
biopsies
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Other Intervention Name(s)
immunohistochemistry
Intervention Description
Correlative studies
Intervention Type
Genetic
Intervention Name(s)
western blotting
Other Intervention Name(s)
Blotting, Western, Western Blot
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
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
Secondary Outcome Measure Information:
Title
Overall Response Rate
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
Title
Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
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
Title
Percent Change in CD20 Antigen Expression and Density of Expression
Description
Percent change in CD20 antigen expression and density of expression
Time Frame
At 4 years
Title
Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
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
Title
Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
Description
Mean percent change in INF level from baseline.
Time Frame
Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
Title
Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
Description
Mean percent change in MFI level from baseline.
Time Frame
Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Hernandez-ILizaliturri
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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