Clinical trial · Interventional
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma
A Phase II Study of Yttrium-90-Labeled Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as First Line Treatment in Indolent Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company withdrew drug supply
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others, such as yttrium Y 90 ibritumomab tiuxetan, find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving rituximab together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with indolent 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 (1)
- type
- EXPERIMENTAL
- label
- Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
- description
- Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
- interventionNames
- Biological: rituximab
- Radiation: yttrium Y 90 ibritumomab tiuxetan
Primary outcomes (2)
- measure
- Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks
- timeFrame
- 14 weeks
- description
- INTERNATIONAL WORKSHOP RESPONSE CRITERIA FOR NON HODGKIN'S LYMPHOMA Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non Hodgkin's lymphoma. J Clin Oncol 1999;17(4):1244-53.
- measure
- EFS
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed indolent non-Hodgkin's lymphoma (NHL), including 1 of the following histologic subtypes:
* Grade1 or 2 follicular lymphoma
* Small lymphocytic lymphoma (SLL)
* Marginal zone B-cell lymphoma
* CD20-positive disease confirmed by immunohistochemistry or flow cytometry
* Bidimensionally measurable disease
* At least 1 lesion measuring ≥ 2.0 cm in a single dimension by CT scan
* Less than 25% bone marrow involvement with lymphoma by bilateral iliac crest bone marrow aspiration and biopsy within the past 6 weeks
* No clinically significant impaired bone marrow reserve as evidenced by any of the following:
* Hypocellular marrow, as evidenced by 1 of the following:
* ≤ 15% cellularity
* Marked reduction in bone marrow precursors
* Platelet count \< 100,000/mm\^3
* Absolute neutrophil count \< 1,500/mm\^3
* History of failed stem cell collection
* Prior myeloablative therapy
* No greater than 5,000/mm\^3 circulating tumor cells in peripheral blood
* Requires antilymphoma therapy, as indicated by any of the following:
* Systemic symptoms
* B symptoms
* Cytopenias
* Malaise
* Organ compromise
* Discomfort
* Pain
* Disfigurement
* Rapidly progressive disease
* Undue anxiety related to not receiving treatment
* No transformation to intermediate or high-grade NHL
* No known brain metastases or CNS involvement by lymphoma 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
* Over 18
Performance status
* ECOG 0-2 OR
* WHO 0-2 OR
* Karnofsky 70-100%
Life expectancy
* More than 3 months
Hematopoietic
* See Disease Characteristics
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Lymphocyte count \< 5,000/mm\^3 (for patients with SLL )
Hepatic
* Bilirubin ≤ 2.0 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal
Renal
* Creatinine ≤ 2.0 mg/dL OR
* Creatinine clearance \> 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Immunologic
* No anti-murine antibody reactivity (in patients with prior exposure to murine antibodies or proteins)
* No ongoing or active infection
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to yttrium Y 90 ibritumomab tiuxetan
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 1 year after study treatment
* No other active malignancy except non-melanoma skin cancer
* No other serious nonmalignant disease that would preclude study participation
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior pegfilgrastim
* More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior external beam radiotherapy to \> 25% of active bone marrow (involved field or regional)
Surgery
* More than 4 weeks since prior major surgery except diagnostic surgery
Other
* No prior systemic antilymphoma therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer therapy
* No other concurrent investigational agents
* No other concurrent antilymphoma therapyReferences
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