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

April 14, 2017 updated by: David Maloney, Fred Hutchinson Cancer Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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: laboratory biomarker analysis
Correlative studies
Biological: rituximab
Given IV
Other Names:
  • Rituxan
  • Mabthera
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • MOAB IDEC-C2B8
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Drug: dexamethasone
Given IV
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Other: 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: laboratory biomarker analysis
Correlative studies
Biological: rituximab
Given IV
Other Names:
  • Rituxan
  • Mabthera
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • MOAB IDEC-C2B8
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Drug: dexamethasone
Given IV
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 3 and 6 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 6 months, 12 months and 24 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

August 29, 2011

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria

October 25, 2005

First Posted (Estimate)

October 27, 2005

Study Record Updates

Last Update Posted (Actual)

May 22, 2017

Last Update Submitted That Met QC Criteria

April 14, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSOC 2002
  • NCI-2011-00576 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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