NCT00004889

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstrom's macroglobulinemia.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2 lymphoma

Timeline
Completed

Started Dec 1999

Geographic Reach
2 countries

8 active sites

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

December 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

February 12, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2012

Enrollment Period

2.1 years

First QC Date

March 7, 2000

Last Update Submit

July 30, 2020

Conditions

Lymphoma

Keywords

Waldenstrom macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • Response (delay in disease progression or timing of disease progression)

    Define objective response (delay in disease progression or timing of disease progression), time to treatment failure, and toxicity for single agent Rituxan therapy in Waldenstrom's macroglobulinemia patients

    24 weeks

Secondary Outcomes (1)

  • Expression of CD20

    24 weeks

Study Arms (1)

Rituxan

EXPERIMENTAL

375 mg/m2 given as an intravenous (IV) infusion once weekly for four doses (days 1, 8, 15, and 22). For purposes of this study 4 weekly courses will constitute one cycle of therapy.

Biological: rituximab

Interventions

rituximabBIOLOGICAL

375 mg/m2 given as an intravenous (IV) infusion once weekly for four doses (days 1, 8, 15, and 22). For purposes of this study 4 weekly courses will constitute one cycle of therapy.

Also known as: Rituxan
Rituxan

Eligibility Criteria

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

You may qualify if:

  • Waldenstrom's Macroglobulinemia requiring therapy who have received no more than 2 prior courses of therapy; previously untreated patients with slowly progressive WM if the patient can reasonably be expected to not require chemotherapy or steroid therapy for 90 days
  • CD20 positive tumor cells
  • Presence of monoclonal paraprotein
  • Minimum IgM level \> 2 times the upper limit of normal
  • Adequate organ function: ANC\>1000/uL; PLT \> 25000/uL; serum creatinine \< 2.5; serum total bilirubin and SGOT \< 2.5 times the upper limit of normal
  • years and older
  • Life expectancy of 6 months or greater
  • ECOG performance status of 0-2
  • Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 6 months after completion of treatment

You may not qualify if:

  • Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry
  • Patients who are pregnant
  • Serious co-morbid disease
  • Uncontrolled bacterial, fungal, or viral infection
  • Active second malignancy
  • Individuals who cannot provide informed written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

LymphomaWaldenstrom Macroglobulinemia

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms 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 GlobulinsGlobulins

Study Officials

  • Christos E. Emmanouilides, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2000

First Posted

February 12, 2004

Study Start

December 1, 1999

Primary Completion

January 1, 2002

Study Completion

July 1, 2005

Last Updated

August 3, 2020

Record last verified: 2012-07

Locations

CA(1)US(7)