Clinical trial · Interventional
Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia
Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
- 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 such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of Waldenstrom's macroglobulinemia * CD20 positive by bone marrow immunohistochemistry or flow cytometry * Presence of monoclonal paraprotein * IgM level at least 2 times upper limit of normal (ULN) PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * At least 6 months Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 25,000/mm\^3 Hepatic: * Bilirubin less than 2.5 times ULN * SGOT less than 2.5 times ULN Renal: * Creatinine less than 2.5 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 6 months after study * No serious comorbid disease * No uncontrolled bacterial, fungal, or viral infection * No other active malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior rituximab * No prior nucleoside analogue therapy Chemotherapy: * At least 30 days since prior chemotherapy Endocrine therapy: * At least 30 days since prior steroid therapy * No concurrent corticosteroids Radiotherapy: * At least 30 days since prior radiotherapy Surgery: * Not specified Other: * No more than 2 prior courses of therapy
References
Publications (1)
- RESULTTreon SP, Branagan AR, Ioakimidis L, Soumerai JD, Patterson CJ, Turnbull B, Wasi P, Emmanouilides C, Frankel SR, Lister A, Morel P, Matous J, Gregory SA, Kimby E. Long-term outcomes to fludarabine and rituximab in Waldenstrom macroglobulinemia. Blood. 2009 Apr 16;113(16):3673-8. doi: 10.1182/blood-2008-09-177329. Epub 2008 Nov 17. PMID 19015393