Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma
NCT ID: NCT01682044
Last Updated: 2017-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2007-04-17
2016-12-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
pegfilgrastim
Given SC
rituximab
Given IV
flow cytometry
Correlative studies
biopsy
Correlative studies
immunohistochemistry staining method
Correlative studies
western blotting
Correlative studies
Interventions
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pegfilgrastim
Given SC
rituximab
Given IV
flow cytometry
Correlative studies
biopsy
Correlative studies
immunohistochemistry staining method
Correlative studies
western blotting
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
19 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Francisco Hernandez-ILizaliturri
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2011-00134
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 83106
Identifier Type: -
Identifier Source: org_study_id
NCT00524628
Identifier Type: -
Identifier Source: nct_alias