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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01682044
First received: September 5, 2012
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: Up to 43 weeks ] [ Designated as safety issue: No ]
    Two-sided 95% exact confidence intervals around the estimates will be calculated. Overall performance on study (weight loss, change in Karnofsky Scores) will be measured. Radiologic evaluation of the extent of disease following therapy will be used to assess response according to the standard World Health Organization (WHO) response criteria.

  • Complete response (CR) [ Time Frame: Up to 43 weeks ] [ Designated as safety issue: No ]
    Two-sided 95% exact confidence intervals around the estimates will be calculated. Summarized overall for the intent-to-treat and the evaluable populations. Overall performance on study (weight loss, change in Karnofsky Scores) will be measured. Radiologic evaluation of the extent of disease following therapy will be used to assess response according to the standard WHO response criteria.

  • Partial response (PR) rates [ Time Frame: Up to 43 weeks ] [ Designated as safety issue: No ]
    Two-sided 95% exact confidence intervals around the estimates will be calculated. Summarized overall for the intent-to-treat and the evaluable populations. Overall performance on study (weight loss, change in Karnofsky Scores) will be measured. Radiologic evaluation of the extent of disease following therapy will be used to assess response according to the standard WHO response criteria.


Secondary Outcome Measures:
  • Time to disease progression, defined as date of progression/death/last contact to the date treatment started [ Time Frame: At 2 years ] [ Designated as safety issue: No ]
    Descriptive statistics such as median, minimum, and maximum values will be used to summarize the time to event data. Kaplan-Meier estimates will be used.

  • Time to disease progression, defined as date of progression/death/last contact to the date treatment started [ Time Frame: At 4 years ] [ Designated as safety issue: No ]
    Descriptive statistics such as median, minimum, and maximum values will be used to summarize the time to event data. Kaplan-Meier estimates will be used.

  • Survival, defined as date of death/last contact to the date treatment started [ Time Frame: At 2 years ] [ Designated as safety issue: No ]
    Descriptive statistics such as median, minimum, and maximum values will be used to summarize the time to event data. Kaplan-Meier estimates will be used. Overall performance on study (weight loss, change in Karnofsky Scores) will be measured.

  • Survival, defined as date of death/last contact to the date treatment started [ Time Frame: At 4 years ] [ Designated as safety issue: No ]
    Descriptive statistics such as median, minimum, and maximum values will be used to summarize the time to event data. Kaplan-Meier estimates will be used. Overall performance on study (weight loss, change in Karnofsky Scores) will be measured.


Enrollment: 20
Study Start Date: April 2007
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682044

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Francisco Hernandez-ILizaliturri Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01682044     History of Changes
Obsolete Identifiers: NCT00524628
Other Study ID Numbers: I 83106, NCI-2011-00134
Study First Received: September 5, 2012
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 14, 2014