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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00244855
First Posted: October 27, 2005
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Maloney, Fred Hutchinson Cancer Research Center
  Purpose
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

Condition Intervention Phase
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 Other: pharmacological study Biological: rituximab Drug: dexamethasone Other: laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rituximab and Dexamethasone in CD20 Positive Low Grade and Follicular Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by David Maloney, Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: At 3 and 6 months after enrollment ]
    Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method


Secondary Outcome Measures:
  • Survival [ Time Frame: At 6 months, 12 months and 24 months after enrollment ]
    Percentage of patients remaining alive estimated according to the Kaplan-Meier method


Enrollment: 32
Study Start Date: May 2004
Study Completion Date: August 29, 2011
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Biological: rituximab
Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan
Drug: dexamethasone
Given IV
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Other: laboratory biomarker analysis
Correlative studies
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.
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Biological: rituximab
Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan
Drug: dexamethasone
Given IV
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244855


Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: David Maloney Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

Responsible Party: David Maloney, Principal Investigator, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00244855     History of Changes
Other Study ID Numbers: PSOC 2002
NCI-2011-00576 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: October 25, 2005
First Posted: October 27, 2005
Results First Submitted: April 14, 2017
Results First Posted: May 22, 2017
Last Update Posted: May 22, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Dexamethasone acetate
Dexamethasone
Rituximab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents