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NCT00244855 · REGISTRY CONDITION SEARCH

Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-05-22

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Other: pharmacological study
    2. Biological: rituximab
    3. Drug: dexamethasone
    4. Other: laboratory biomarker analysis
    label
    No previous treatment
    type
    OTHER
  2. description
    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.
    intervention Names
    1. Other: pharmacological study
    2. Biological: rituximab
    3. Drug: dexamethasone
    4. Other: laboratory biomarker analysis
    label
    Previous treatment
    type
    OTHER
interventions
  1. arm Group Labels
    1. No previous treatment
    2. Previous treatment
    description
    Correlative studies
    name
    pharmacological study
    other Names
    1. pharmacological studies
    type
    OTHER
  2. arm Group Labels
    1. No previous treatment
    2. Previous treatment
    description
    Given IV
    name
    rituximab
    other Names
    1. IDEC-C2B8
    2. IDEC-C2B8 monoclonal antibody
    3. Mabthera
    4. MOAB IDEC-C2B8
    5. Rituxan
    type
    BIOLOGICAL
  3. arm Group Labels
    1. No previous treatment
    2. Previous treatment
    description
    Given IV
    name
    dexamethasone
    other Names
    1. Aeroseb-Dex
    2. Decaderm
    3. Decadron
    4. DM
    5. DXM
    type
    DRUG
  4. arm Group Labels
    1. No previous treatment
    2. Previous treatment
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
32
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method
    measure
    Progression-free Survival
    time Frame
    At 3 and 6 months after enrollment
secondary Outcomes
  1. description
    Percentage of patients remaining alive estimated according to the Kaplan-Meier method
    measure
    Survival
    time Frame
    At 6 months, 12 months and 24 months after enrollment
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
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        exact text
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      offset unit
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      query cond
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      query disease state id
      ds-plasma-cell-neoplasms
      source file
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      source file sha256
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      source json pointer
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      source kind
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      source string sha256
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    Preserved source evidence · Not medical advice