Clinical trial · Interventional
Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
NCT00117156CI-TRIAL-00023325completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphoma (MZL) or CD5-, CD10-, CD20+ low-grade B cell lymphomas.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| MALT Lymphoma | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine | Drug | Fludarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fludarabine and Rituximab
- description
- Fludarabine: 25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles Rituximab: 375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
- interventionNames
- Drug: Fludarabine
- Drug: Rituximab
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- Assessed after three- and six-cycles of therapy.
- description
- Objective response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on Cheson criteria (1999).
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTBrown JR, Friedberg JW, Feng Y, Scofield S, Phillips K, Dal Cin P, Joyce R, Takvorian RW, Fisher DC, Fisher RI, Liesveld J, Marquis D, Neuberg D, Freedman AS. A phase 2 study of concurrent fludarabine and rituximab for the treatment of marginal zone lymphomas. Br J Haematol. 2009 Jun;145(6):741-8. doi: 10.1111/j.1365-2141.2009.07677.x. Epub 2009 Mar 30. PMID 19344412