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



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:10/11/2017
Start Date:April 17, 2007
End Date:December 22, 2016

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Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma

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

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.

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
We found this trial at
1
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
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