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

NCT01682044 | Completed Phase 2 Results DMC

• 2 other identifiers: I 83106NCI-2011-00134
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 90 days after the last dose of study drugs

Secondary Outcomes (6)

• Overall Response Rate

  Up to 43 weeks

• Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline

  Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39

• 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

  Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39

• Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline

  Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39

Study Arms (1)

Treatment (colony-stimulating factor and monoclonal antibody)

EXPERIMENTAL

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; Biological: rituximab; Other: flow cytometry; Procedure: biopsy; Other: immunohistochemistry staining method; Genetic: western blotting

Interventions

pegfilgrastim BIOLOGICAL

Given SC

Also known as: Filgrastim SD-01, GCSF-SD01, Neulasta, SD-01 sustained duration G-CSF

Treatment (colony-stimulating factor and monoclonal antibody)

rituximab BIOLOGICAL

Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan

Treatment (colony-stimulating factor and monoclonal antibody)

flow cytometry OTHER

Correlative studies

Treatment (colony-stimulating factor and monoclonal antibody)

biopsy PROCEDURE

Correlative studies

Also known as: biopsies

Treatment (colony-stimulating factor and monoclonal antibody)

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Treatment (colony-stimulating factor and monoclonal antibody)

western blotting GENETIC

Correlative studies

Also known as: Blotting, Western, Western Blot

Treatment (colony-stimulating factor and monoclonal antibody)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone; Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

pegfilgrastim; Rituximab; Flow Cytometry; Biopsy; Immunohistochemistry; Blotting, Western

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Histocytochemistry; Histological Techniques; Immunologic Techniques; Electrophoresis; Electrochemical Techniques; Immunoblotting; Immunoassay; Molecular Probe Techniques

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Francisco Hernandez-ILizaliturri

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 10, 2012
• Study Start: April 17, 2007
• Primary Completion: November 22, 2013
• Study Completion: December 22, 2016
• Last Updated: October 9, 2017
• Results First Posted: October 9, 2017

Record last verified: 2017-09

Locations

US (1)