Clinical trial · Interventional
Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma
International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy
- 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: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may be effective in treating cancer and blocking the body's immune response. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving doxorubicin together with vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
| yttrium Y 90 ibritumomab tiuxetan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-CHOP14 chemotherapy
- interventionNames
- Biological: rituximab
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: prednisone
- Drug: vincristine sulfate
- Radiation: yttrium Y 90 ibritumomab tiuxetan
Primary outcomes (1)
- measure
- Event-free Survival
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Overall Survival
- timeFrame
- 2 years
- measure
- Relapse-free Survival in Responding Patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed large B-cell lymphoma * Stage I, II, III, or IV disease * Bone marrow or lymph node involvement by small cell lymphoma allowed * No serious, progressive pathology (at investigator's discretion) * CD20-positive disease * Measurable disease * No prior indolent lymphoma, treated or not * No meningeal or CNS lymphoma PATIENT CHARACTERISTICS: * International prognostic index \< 2 (adjusted for age) * Life expectancy \> 3 months * ALT and AST ≤ 2.5 times upper limit of normal * Bilirubin ≤ 30 mmol/L * Creatinine ≤ 150 μmol/L * HIV, hepatitis B virus, and hepatitis C virus negative (unless after vaccine) * No contraindication to chemotherapy or immunotherapy * No cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix * No contraindication to a venous catheter PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 30 days since prior and no other concurrent investigational treatment * No prior therapy * No concurrent participation in another clinical study
References
Publications (0)
Data not yet available