Clinical trial · Interventional
Radiolabeled Monoclonal Antibody in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Phase I, Multicenter, Open Label, Dose Escalation Of 90Y-Zevalin Radioimmunotherapy Using A Modified Treatment Regimen For Relapsed Or Refractory CD20+ B-Cell (Follicular/Transformed) Non-Hodgkin's Lymphoma
- 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 I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
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 |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- First radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
- interventionNames
- Biological: rituximab
- Radiation: yttrium Y 90 ibritumomab tiuxetan
- type
- EXPERIMENTAL
- label
- Cohort II
- description
- Second radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
- interventionNames
- Biological: rituximab
- Radiation: yttrium Y 90 ibritumomab tiuxetan
- type
- EXPERIMENTAL
- label
- Cohort III
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed low-grade, follicular, or transformed CD20-positive B-cell non-Hodgkin's lymphoma (NHL) * Relapsed after prior chemotherapy OR chemotherapy-resistant disease * Failed at least 1 prior chemotherapy regimen * CD20-positive B-cell population in lymph nodes or bone marrow for International Working Formulation A (small lymphocytic lymphoma) and transformed NHL * Bone marrow involvement with lymphoma less than 25% bilaterally * No impaired bone marrow reserve defined as at least 1 of the following criteria: * Prior myeloablative therapies with bone marrow transplantation or peripheral blood stem cell rescue * Platelet count less than 100,000/mm3 * Bone marrow cellularity no greater than 15% * Marked reduction in bone marrow precursors of one or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid) * Failed prior stem cell collection * No CNS lymphoma, chronic lymphocytic lymphoma, or HIV or AIDS-related lymphoma * No diffuse small lymphocytic/marginal zone lymphoma with lymphocyte count greater than 5,000/mm\^3 * No pleural effusion NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * 19 and over Performance status: * WHO 0-2 Life expectancy: * At least 6 months Hematopoietic: * See Disease Characteristics * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hematocrit greater than 30% * Hemoglobin greater than 9.0 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * No anti-murine antibody reactivity if prior exposure to murine antibodies or proteins * No other primary malignancy * No other serious nonmalignant disease or infection that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior radioimmunotherapy * Prior rituximab allowed if more than 6 months to progression after an objective response * At least 6 weeks since prior rituximab * At least 3 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) * Recovered from prior immunotherapy Chemotherapy: * See Disease Characteristics * No prior fludarabine * At least 3 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No concurrent chemotherapy Endocrine therapy: * At least 3 weeks since prior anticancer endocrine therapy * No concurrent high-dose systemic corticosteroids (e.g., 50 mg or more of prednisone as a single dose or 50 mg or less of prednisone for more than 6 doses) Radiotherapy: * No prior radiotherapy to more than 25% of active bone marrow (involved field or regional) * At least 3 weeks since prior anticancer radiotherapy and recovered Surgery: * At least 4 weeks since prior surgery (except diagnostic surgery) and recovered Other: * No other concurrent anticancer therapy * Concurrent oral anticoagulant therapy allowed if platelet count is at least 30,000/mm3
References
Publications (1)
- RESULTForero-Torres A, Besh S, Knox S, et al.: Higher doses of Rituxan alter pharmacokinetics and biodistribution of Zevalin but may increase responses; a preliminary report of a phase I study of Zevalin using a modified treatment regimen for relapsed or refractory CD20+ B-Cell follicular/transformed non-Hodgkins lymphoma. [Abstract] Blood 102 (11 Pt 1): A-1483, 2003.