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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


OBJECTIVES:

Primary

- Evaluate the safety of rituximab and pegfilgrastim in patients with untreated or
relapsed/recurrent follicular lymphoma, small lymphocytic lymphoma, or marginal zone
lymphoma.

Secondary

- Evaluate the efficacy (including overall response rate and durability of objective
responses) of this regimen in these patients.

- Evaluate functional and phenotypic characteristics of host neutrophils.

- Evaluate changes of CD20 antigen expression and density of expression.

- Evaluate changes in serum tumor necrosis factor (TNF), interferon alpha, and free
radical levels.

OUTLINE: Patients receive rituximab IV once a week in weeks 1, 3, 5, 7, 15, 23, 31, and 39
and pegfilgrastim subcutaneously 3 days before receiving rituximab for a total of 8 doses.
Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and periodically during study treatment
for correlative studies. Samples are analyzed for phenotype changes in neutrophils,
oxidative burst, and cytokine levels by flow cytometry and in vitro functional assays.
Patients with easily accessible lymphomatous lesions undergo excisional biopsy within 24
hours after completion of first dose of rituximab. Tissues are analyzed for infiltration of
neutrophils into tumor bed, changes in CD20 expression by immunohistochemistry, flow
cytometry, and western blot, and evidence of apoptosis.

After completion of study treatment, patients are followed every 4 months for 1 year, every
6 months for 2 years, and once at year 4.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following indolent, B-cell non-Hodgkin lymphoma:

- Grade 1, 2, or 3a follicular lymphoma

- Small lymphocytic lymphoma

- Marginal zone lymphoma

- Previously untreated, relapsed, or recurrent disease

- No limit to prior treatments

- CD20-positive disease

- Measurable tumor size, defined as at least 1 node measuring 4 cm² bidimensionally

- No premalignant myeloid condition

- No malignancy with myeloid characteristics (e. g., myelodysplastic syndrome, acute or
chronic myelogenous leukemia)

- No CNS lymphoma

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Expected survival > 6 months

- ANC > 1,000/mm³

- Platelet count > 50,000/mm³

- Hemoglobin ≥ 8 g/dL (erythropoietin growth factor allowed)

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL

- AST < 5 times ULN

- Alkaline phosphatase < 5 times ULN

- HIV-negative

- No serious nonmalignant disease (e.g., active uncontrolled bacterial, viral, or
fungal infections) or other conditions that would compromise protocol objectives

- No other malignancy within the past 5 years except squamous cell or basal cell skin
cancer or carcinoma in situ of the cervix

- No history of cardiac disease, defined as NYHA class II-IV cardiac disease

- No clinical evidence of congestive heart failure

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No know hypersensitivity to any recombinant E. coli-derived product, murine proteins,
or any components of the study medication

PRIOR CONCURRENT THERAPY:

- Fully recovered from prior surgery, radiotherapy, chemotherapy, or immunotherapy

- Prior rituximab or other monoclonal immunotherapy allowed

- No chemotherapy within 4 weeks of the first scheduled study treatment

- No major surgery, other than diagnostic surgery, within the past 4 weeks

- More than 30 days since prior participation in another investigational device or drug
trial

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate at weeks 11, 27, and 43

Outcome Description:

AT Weeks 11, 27, 43

Outcome Time Frame:

AT Weeks 11, 27, 43

Safety Issue:

No

Principal Investigator

Francisco J. Hernandez-Ilizaturri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000562751

NCT ID:

NCT00524628

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • recurrent small lymphocytic lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • stage I marginal zone lymphoma
  • stage III marginal zone lymphoma
  • stage IV marginal zone lymphoma
  • contiguous stage II marginal zone lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • nodal marginal zone B-cell lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • splenic marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263