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Rituximab and Dexamethasone in CD20 Positive Low Grade and Follicular Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Cutaneous B-cell Non-Hodgkin 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 Marginal Zone Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Marginal Zone Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Marginal Zone Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia

Thank you

Trial Information

Rituximab and Dexamethasone in CD20 Positive Low Grade and Follicular Non-Hodgkin's Lymphoma


PRIMARY OBJECTIVES:

I. To estimate clinical response rate (RR) at 3 and 6 months. II. To estimate Grade 2-4
-infusion-related toxicity.

SECONDARY OBJECTIVES:

I. To evaluate laboratory parameters and correlate with clinical response including:
antibody dependent cell mediated cytotoxicity and effector cell phenotype analysis at
baseline, 4 weeks and three months.

II. To evaluate laboratory parameters and correlate with clinical response including:
soluble cluster of differentiation (CD)20 fragments or CD20-containing membrane fragments at
baseline, 4 weeks, and 3 months.

III. To evaluate laboratory parameters and correlate with clinical response including:
phenotype analysis of CD16 and CD32 on natural killer (NK) cells.

IV. To evaluate laboratory parameters and correlate with clinical response including:
rituximab pharmacokinetic studies at baseline, 4 weeks and 3 months.

OUTLINE:

Patients receive dexamethasone intravenously (IV) and rituximab IV once weekly. Treatment
continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3 and 6 months.


Inclusion Criteria:



- Patients must have histologically proven CD20+ low grade B cell lymphoma including
follicular, marginal zone, monocytoid B cell, and lymphoplasmacytoid lymphoma;
patients may be previously untreated or in relapse

- Patients must have measurable disease with clearly defined margins assessed by
physical exam with direct measurement (for cutaneous B-cell lymphomas), computed
tomography (CT) or magnetic resonance imaging (MRI), defined as >= 20 mm with
conventional CT or MRI or >= 10 mm using spiral CT scan

- Absolute neutrophil count >= 1000/mm^3

- Hemoglobin > 7 g/dl

- Platelets >= 100,000/mm^3

- Serum creatinine =< 2.5 mg/dl

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2x the upper
limit of normal (ULN)

- Karnofsky performance score >= 70 %

- Patient has signed an Institutional Review Board (IRB) approved informed consent form
that conforms to federal and institutional guidelines

Exclusion Criteria:

- Patient has received rituximab therapy within 6 months of entry into protocol

- Patient has received systemic steroid therapy within one month of entry into protocol

- Patient has Intermediate or High Grade NHL, mantle cell lymphoma, chronic lymphocytic
leukemia, or small lymphocytic lymphoma

- Patient is pregnant or lactating

- Patient is unwilling or unable to practice contraception during treatment and for one
year thereafter

- Patient has active central nervous system (CNS) disease

- Patient has human immunodeficiency virus (HIV) disease

- Patient has an active infection requiring antimicrobial therapy

- Patient has significant heart disease, New York Heart Classification III or IV heart
disease (III: Marked limitation of physical activity; comfortable at rest, but less
than ordinary activity causes fatigue, or dyspnea; IV: Unable to carry on any
physical activity without symptoms; symptoms are present even at rest; if any
physical activity is undertaken, symptoms are increased)

- Patient requires supplemental oxygen

- Patient has a concomitant malignancy or previous malignancy within the last five
years, with the exception of adequately treated basal or squamous cell carcinoma of
the skin, or in situ cervical or in situ breast cancer

- Patients with active hepatitis B virus (HBV) infection or hepatitis, or with
hepatitis C positive serology

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical RR

Outcome Description:

Response rates will be assessed separately among previously treated or refractory patients and those previously untreated.

Outcome Time Frame:

Baseline, and at 3 and 6 months after completion of treatment

Safety Issue:

No

Principal Investigator

David Maloney

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

PSOC 2002

NCT ID:

NCT00244855

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Contiguous Stage II Grade 1 Follicular Lymphoma
  • Contiguous Stage II Grade 2 Follicular Lymphoma
  • Contiguous Stage II Marginal Zone Lymphoma
  • Cutaneous B-cell Non-Hodgkin 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 Marginal Zone Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Stage I Grade 1 Follicular Lymphoma
  • Stage I Grade 2 Follicular Lymphoma
  • Stage I Marginal Zone Lymphoma
  • Stage III Grade 1 Follicular Lymphoma
  • Stage III Grade 2 Follicular Lymphoma
  • Stage III Marginal Zone Lymphoma
  • Stage IV Grade 1 Follicular Lymphoma
  • Stage IV Grade 2 Follicular Lymphoma
  • Stage IV Marginal Zone Lymphoma
  • Waldenström Macroglobulinemia
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109