search
Back to results

Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rituximab
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Waldenstrom macroglobulinemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 18 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 Exclusion Criteria: 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

Sites / Locations

  • Cancer Center and Beckman Research Institute, City of Hope
  • Jonsson Comprehensive Cancer Center, UCLA
  • Walter Reed Army Medical Center
  • Massachusetts General Hospital Cancer Center
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • Cross Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituxan

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Expression of CD20
To correlate expression and changes in expression of CD20 on waldenstrom's macroglobulinemia patient plasma cells and B-cells with clinical responses.

Full Information

First Posted
March 7, 2000
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Genentech, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00004889
Brief Title
Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia
Official Title
Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
January 2002 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVES: I. Determine the objective response, time to treatment failure, and toxicity in patients with Waldenstrom's macroglobulinemia treated with rituximab. II. Correlate expression and changes in expression of CD20 on patient plasma cells and B-cells with clinical responses. OUTLINE: This is a multicenter study. Patients receive rituximab IV weekly for 4 weeks. Treatment may be repeated 2 months later in patients with stable disease, partial response, or complete response. Patients are followed every 6 months for 2 years. PROJECTED ACCRUAL: A total of 12-25 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Waldenstrom macroglobulinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituxan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response (delay in disease progression or timing of disease progression)
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Expression of CD20
Description
To correlate expression and changes in expression of CD20 on waldenstrom's macroglobulinemia patient plasma cells and B-cells with clinical responses.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 18 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christos E. Emmanouilides, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center and Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

We'll reach out to this number within 24 hrs