Clinical trial · Interventional
Rituximab and Combination Chemotherapy Combined With Yttrium Y 90 Ibritumomab Tiuxetan in Treating Older Patients With Previously Untreated B-Cell Lymphoma
A Phase II Study of R-CHOP and Ibritumomab Tiuxetan (Zevalin) for Elderly Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
NCT00058422CI-TRIAL-00048218completedPhase 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 rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and combination chemotherapy with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab and combination chemotherapy with yttrium Y 90 ibritumomab tiuxetan in treating older patients who have B-cell lymphoma that has not been previously treated.
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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| darbepoetin alfa | Biological | — | UNRESOLVED |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| indium In 111 ibritumomab tiuxetan | Radiation | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-CHOP and Ibritumomab Tiuxetan (Zevalin)
- description
- Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0. Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
- interventionNames
- Biological: darbepoetin alfa
- Biological: filgrastim
- Biological: rituximab
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: prednisone
- Drug: vincristine sulfate
- Radiation: indium In 111 ibritumomab tiuxetan
- Radiation: yttrium Y 90 ibritumomab tiuxetan
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed diffuse large B-cell lymphoma, including any of the following subtypes: * Centroblastic * Immunoblastic * T-cell/histiocyte-rich * Lymphomatoid granulomatosis type * Anaplastic large B-cell * Plasmablastic * Mediastinal * Intravascular large B-cell lymphoma * Previously untreated * High-intermediate or high-risk disease, defined by an age-adjusted international prognostic index score of 2 or 3 (with 1 point each assigned for a ECOG greater than 1/Karnofsky less than 80%, lactate dehydrogenase greater than normal, and stage III or IV) * Lymphomas with discordant histology and a diffuse large B-cell component are eligible * Must have an initial diagnostic specimen that is CD20+ * At least Ann Arbor stage II disease * No confinement of disease to an involved-field radiotherapy port (stage I or limited stage II disease) * Bidimensionally measurable disease with at least 1 lymph node at least 2.0 cm by 2.0 cm by physical examination, CT scan, or positron-emission tomography * Bone marrow cellularity greater than 15% * No known brain or leptomeningeal metastases * No primary effusion lymphomas PATIENT CHARACTERISTICS: Age * 60 and over\* NOTE: \*Patients 60 to 65 years of age must be deemed ineligible for autologous stem cell transplantation Performance status * Karnofsky 50-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 2.0 mg/dL (except for Gilbert's disease) Renal * Creatinine no greater than 1.5 mg/dL\* OR * Creatinine clearance greater than 50 mL/min\* NOTE: \*Patients not meeting either criterion but who have renal insufficiency directly related to lymphomatous involvement of the kidneys or renal collecting system are allowed Cardiovascular * Cardiac ejection fraction at least 50% by echocardiogram * No acute myocardial infarction within the past 3 months * No uncontrolled hypertension * No New York Heart Association class III or IV congestive heart failure * No unstable angina pectoris Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * B12 and folate greater than the lower limit of normal * Transferrin saturation at least 15% * Ferritin greater than 10 µg/L * At least 6 weeks since prior RBC donation * No active seizure disorder * Prior seizure disorder allowed if free of antiseizure medication and evidence of seizure activity for the past 5 years * No concurrent uncontrolled medical problems that would preclude administration of chemotherapy or radioimmunotherapy * No other concurrent malignancy treated with chemotherapy or radiotherapy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior RBC transfusion * No prior biologic therapy * No other concurrent biologic therapy Chemotherapy * No prior chemotherapy (one course of R-CHOP allowed) * No other concurrent standard or investigational chemotherapy Endocrine therapy * No more than 7 consecutive days of prior steroids (premedication allowed for prior intravenous contrast allergy) * No other concurrent corticosteroids Radiotherapy * No prior radiotherapy Surgery * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.