Clinical trial · Interventional
Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstrom's Macroglobulinemia
Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma)
NCT00060294CI-TRIAL-00008811terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no accrual
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 ibritumomab tiuxetan 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 |
|---|---|---|---|
| rituximab | Biological | Rituximab | ALIAS |
| yttrium Y 90 ibritumomab tiuxetan | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of Waldenstrom's macroglobulinemia confirmed by IgM gammopathy and bone marrow biopsy * Presence of lymphoplasmacytic cells * CD20+ plasma cell dyscrasia on the majority of malignant cells * Bone marrow involvement of 20-50% by core needle biopsy of at least 1.5 cm in length * Clinical indication for initiation of treatment, including 1 or more of the following characteristics: * Symptoms associated with the disease (e.g., fatigue, asthenia, or painful adenopathy) * Anemia * IgM greater than 3 g/L * Progression as indicated by a rate of IgM rise of more than 0.5 g over 6 months * No myelodysplastic syndromes or profound hypocellularity of the bone marrow PATIENT CHARACTERISTICS: Age * Over 18 Performance status * WHO 0-2 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count greater than 1,500/mm\^3 * Total B-lymphocyte count less than 5,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * No hyperviscosity syndrome Hepatic * Bilirubin no greater than 1.5 mg/dL Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 year after study completion * No uncontrolled CNS disease * No serious nonmalignant disease that would preclude study participation * No other concurrent active malignancy except controlled skin cancer or prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy * More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) * More than 4 months since prior rituximab * No prior radioimmunotherapy Chemotherapy * No prior high-dose chemotherapy (unless patient has had prior back-up stem cell collections) * More than 6 weeks since prior chemotherapy Endocrine therapy * More than 4 weeks since prior corticosteroids Radiotherapy * No prior radiotherapy Surgery * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.