NCT00244855

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2011

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

May 22, 2017

Completed
Last Updated

May 22, 2017

Status Verified

April 1, 2017

Enrollment Period

4.6 years

First QC Date

October 25, 2005

Results QC Date

April 14, 2017

Last Update Submit

April 14, 2017

Conditions

Contiguous Stage II Grade 1 Follicular LymphomaContiguous Stage II Grade 2 Follicular LymphomaContiguous Stage II Marginal Zone LymphomaCutaneous B-cell Non-Hodgkin LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Marginal Zone LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Marginal Zone LymphomaSplenic Marginal Zone LymphomaStage I Grade 1 Follicular LymphomaStage I Grade 2 Follicular LymphomaStage I Marginal Zone LymphomaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Marginal Zone LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Marginal Zone LymphomaWaldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival

    Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method

    At 3 and 6 months after enrollment

Secondary Outcomes (1)

  • Survival

    At 6 months, 12 months and 24 months after enrollment

Study Arms (2)

No previous treatment

OTHER

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 studyBiological: rituximabDrug: dexamethasoneOther: laboratory biomarker analysis

Previous treatment

OTHER

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 studyBiological: rituximabDrug: dexamethasoneOther: laboratory biomarker analysis

Interventions

pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
No previous treatmentPrevious treatment
rituximabBIOLOGICAL

Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
No previous treatmentPrevious treatment
dexamethasoneDRUG

Given IV

Also known as: Aeroseb-Dex, Decaderm, Decadron, DM, DXM
No previous treatmentPrevious treatment
laboratory biomarker analysisOTHER

Correlative studies

No previous treatmentPrevious treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal ZoneLymphoma, FollicularWaldenstrom Macroglobulinemia

Interventions

RituximabDexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Results Point of Contact

Title
Dr. David Maloney
Organization
Fred Hutchinson Cancer Research Center
dmaloney@fredhutch.org
206-667-5616

Study Officials

  • David Maloney

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 27, 2005

Study Start

May 1, 2004

Primary Completion

December 1, 2008

Study Completion

August 29, 2011

Last Updated

May 22, 2017

Results First Posted

May 22, 2017

Record last verified: 2017-04

Locations

US(1)