Clinical trial · Interventional
Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
NCT00073957CI-TRIAL-00031298completedPhase 2Results postedClinicalTrials.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, 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. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| liposomal cytarabine | Drug | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
| yttrium Y 90 ibritumomab tiuxetan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Y-90 Ibritumomab Tiuxetan
- description
- Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine
- interventionNames
- Biological: rituximab
- Drug: cytarabine
- Drug: liposomal cytarabine
- Radiation: yttrium Y 90 ibritumomab tiuxetan
Primary outcomes (2)
- measure
- Response Rate = Complete and Partial Response at 12 Weeks.
- timeFrame
- 12 weeks
- description
- Definition Nodal Masses Spleen, Liver Bone Marrow CR Disappearance of all evidence of disease Partial response Regression and no new sites ≥ 50% decrease in sum of the perpendicular dimension of up to 6 largest dominant masses; no increase in size of other nodes Stable disease Failure to attain CR/PR or Progressive disease or Relapsed disease : the appearance of any new lesion or the (a) FDG-avid or PET positive prior to therapy; PET positive at prior sites of disease and no new sites on CT or PET Any new lesion or increase by ≥ 50% of previously involved sites from nadir Appearance of a new lesion(s) \> 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥ 50% increase in longest diameter of a previously identified node \> 1 cm in short axis \> 50% increase from nadir in the SPD of any previous lesions New or recurrent involvement Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following:
* B-cell diffuse large cell variant
* Immunoblastic
* Mediastinal (thymic) large cell
* T-cell/histiocyte-rich
* Anaplastic large B-cell
* Intravascular large B-cell
* Lymphomatoid granulomatosis
* Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment
* Relapsed disease, defined as the following:
* Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site
* 50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node
* Progressive disease, defined as the following:
* 50% increase from nadir in the SPD of any previously identified abnormal node
* Appearance of any new lesion during or at the end of therapy
* CD20-positive disease by immunohistochemistry
* Bidimensionally measurable disease
* At least 1 lesion at least 2.0 cm by CT scan
* Less than 25% bone marrow involvement by lymphoma
* No transformed lymphoma from indolent to aggressive
* No HIV- or AIDS-related lymphoma
* No hypocellular bone marrow
* No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)
* No CNS lymphoma
* Ineligible for myeloablative therapy OR refused transplantation
* Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* WHO 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Lymphocyte count no greater than 5,000/mm\^3 (for patients with small lymphocytic lymphoma)
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 2.0 mg/dL
Renal
* Creatinine no greater than 2.0 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 year after study participation
* No concurrent serious nonmalignant disease or infection that would preclude study participation
* No human antimurine antibody reactivity
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* No prior autologous bone marrow transplantation
* No prior peripheral blood stem cell rescue
* No prior failed stem cell collection
* Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion
* More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* No prior radioimmunotherapy
* No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow
Surgery
* More than 4 weeks since prior major surgery (except diagnostic surgery)
Other
* Recovered from all prior therapy
* More than 4 weeks since prior therapy for lymphoma
* More than 8 weeks since prior phase II investigational drugs
* No other concurrent antineoplastic therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.