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 III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Marginal Zone Lymphoma, Stage I Marginal Zone Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia
Conditions
Brief summary
This phase II trial studies the side effects and how well giving rituximab and dexamethasone together works in treating patients with low-grade non-Hodgkin lymphoma (NHL). Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with dexamethasone may kill more cancer cells
Detailed description
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.
Interventions
Correlative studies
Given IV
Given IV
Correlative studies
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | At 3 and 6 months after enrollment | Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | At 6 months, 12 months and 24 months after enrollment | Percentage of patients remaining alive estimated according to the Kaplan-Meier method |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Previous Treatment Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies | 7 |
| No Previous Treatment Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies | 25 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | No Previous Treatment | Total | Previous Treatment |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 15 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 17 Participants | 3 Participants |
| Age, Continuous | 64 years | 64 years | 67 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 29 Participants | 6 Participants |
| Region of Enrollment United States | 25 participants | 32 participants | 7 participants |
| Sex: Female, Male Female | 17 Participants | 21 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 7 | 16 / 25 |
| serious Total, serious adverse events | 0 / 7 | 0 / 25 |
Outcome results
Progression-free Survival
Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method
Time frame: At 3 and 6 months after enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Previous Treatment | Progression-free Survival | At 3 months after enrollment | 92 Kaplan-Meier estimated % of patients |
| Previous Treatment | Progression-free Survival | At 6 months after enrollment | 83 Kaplan-Meier estimated % of patients |
| No Previous Treatment | Progression-free Survival | At 3 months after enrollment | 71 Kaplan-Meier estimated % of patients |
| No Previous Treatment | Progression-free Survival | At 6 months after enrollment | 71 Kaplan-Meier estimated % of patients |
Survival
Percentage of patients remaining alive estimated according to the Kaplan-Meier method
Time frame: At 6 months, 12 months and 24 months after enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Previous Treatment | Survival | At 6 months | 96 Kaplan-Meier estimated % of patients |
| Previous Treatment | Survival | At 12 months | 96 Kaplan-Meier estimated % of patients |
| Previous Treatment | Survival | At 24 months | 91 Kaplan-Meier estimated % of patients |
| No Previous Treatment | Survival | At 6 months | 100 Kaplan-Meier estimated % of patients |
| No Previous Treatment | Survival | At 12 months | 100 Kaplan-Meier estimated % of patients |
| No Previous Treatment | Survival | At 24 months | 67 Kaplan-Meier estimated % of patients |