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

Completed · Phase 2

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT01682044

Run by

Roswell Park Cancer Institute

People needed

20

Starts

2007-04-17

Expected to finish

2016-12-22

Last updated by the study team

2017-10-09

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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