Status:
COMPLETED
High Dose Rituximab for Initial Treatment of Indolent B-Cell Lymphomas
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
B-cell Lymphoma
Indolent B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to see if increased doses of rituximab are safe and effective for the initial treatment of indolent B-cell lymphomas. Rituximab (Rituxan) is a type of drug called...
Detailed Description
* All participants will receive increased-dose rituximab through a vein in the arm once a week for 4 weeks (on Days 1, 8, 15, and 22 of the initial 28-day study cycle). This first cycle of study treat...
Eligibility Criteria
Inclusion
- Indolent B-Cell NHL of the following histologies:
- Follicular lymphoma (grades 1-3A);
- marginal zone lymphoma (extranodal, nodal or splenic):
- Extranodal marginal zone lymphomas (MALT lymphomas) may not be candidates for cure with antibiotics or local radiotherapy. Patients who have failed antibiotics or local therapy are eligible for the protocol as long as they have measurable disease and are naive to chemotherapy and monoclonal antibody;
- splenic marginal zone lymphoma patients may have received prior splenectomy as long as they have measureable disease and are naive to chemotherapy and monoclonal antibody therapy;
- Small lymphocytic lymphoma (must have less than 5000 circulating clonal B-lymphocytes);
- Indolent CD20+ B-cell lymphoma not otherwise specified with CD20+ expression
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan
- No previous chemotherapy, antibody therapy or radioimmunotherapy for NHL. Patients previously treated with external bean radiation alone, surgery, or with antibiotics are eligible
- 18 years of age or older
- Life expectancy of greater than 3 months
- ECOG performance status of 2 or less
- Adequate bone marrow function
- Use of adequate contraception
Exclusion
- Prior chemotherapy, monoclonal antibody therapy or radioimmunotherapy for lymphoma
- Receiving any other investigational agent
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab
- HIV positivity
- Active hepatitis B infection
- Candidate for curative radiotherapy, unless radiation therapy is considered too toxic (as in abdominal disease), or is refused by the patient
- NYHA Classification III or IV disease
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection that is not optimally treated with antibiotics, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women
- Individuals with a history of a different malignancy except for the following circumstances:
- disease-free for at least 1 year and are deemed by the investigator to be at low risk for recurrence of that malignancy;
- localized prostate cancer, prostate cancer with elevated PSA but no measurable disease on CT scans or bone scan, cervical cancer in situ; and
- non-melanoma skin cancers
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00895661
Start Date
July 1 2009
End Date
August 1 2015
Last Update
June 9 2017
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115