Clinical trial · Interventional
Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia
Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia
NCT00004889CI-TRIAL-00046380completedPhase 2ClinicalTrials.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)
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.
Conditions
Conditions (1)
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 | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituxan
- 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.
- interventionNames
- Biological: rituximab
Primary outcomes (1)
- measure
- Response (delay in disease progression or timing of disease progression)
- timeFrame
- 24 weeks
- 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
Secondary outcomes (1)
- measure
- Expression of CD20
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.