Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT00117156
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed, newly diagnosed or relapsed MALT, marginal zone lymphoma, or low-grade B cell lymphoproliferative disorder which is CD5-, CD10- and CD20+
* Pathology must be reviewed at Brigham \& Women's Hospital, Massachusetts General Hospital, or the University of Rochester James P. Wilmot Cancer Center prior to enrollment
* Documentation of CD20+ status
* Must not be a candidate for local radiotherapy with curative intent
* If gastric MALT, not a candidate for antibiotic therapy with curative intent
* Patients with leukemic phase marginal zone lymphoma are eligible if their absolute lymphocyte count is \>10,000 / µl
* Prior treatment with rituximab is permitted, if rituximab induced an objective response which persisted for at least 6 months
* Prior radiotherapy is acceptable
* Measurable disease
* ANC: \> 1000/mm3
* Platelets: \> 100,000/mm3
* Hemoglobin: \> 7 gm/dL
* Adequate renal function as indicated by serum creatinine \<= 2 mg/dL.
* Adequate liver function, as indicated by serum total bilirubin \<= 2 mg/dL.
* AST or ALT \<3x Upper Limit of Normal unless related to primary disease.
* Men and women of reproductive potential must agree to use an acceptable method of birth control during study treatment and for six months after completion of study treatment.
* WHO Performance status \</= 2
* Subject has provided written informed consent.
Exclusion Criteria:
* Patients with Waldenstrom's Macroglobulinemia or lymphoplasmacytic lymphoma are excluded
* History of HIV
* Active infection
* Known CNS disease
* Pregnant (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or currently lactating women
* Prior treatment within the last three weeks
* Prior fludarabine
* Positive direct antiglobulin test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00117156
Study Brief:
Protocol Section:
NCT00117156