Phase 2
N=30
Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00690560 ↗Enrolled (actual)
30
Serious AEs
33.3%
Results posted
May 2026
Primary outcome: Primary: Event-free Survival — 76 percentage of patient
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Biological); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); prednisone (Drug); vincristine sulfate (Drug); yttrium Y 90 ibritumomab tiuxetan (Radiation)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Centre Antoine Lacassagne
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival |
76 | — |
| SECONDARY Overall Survival |
96.3 | — |
| SECONDARY Relapse-free Survival in Responding Patients |
82 | — |
| SECONDARY Response Rate at the End of Treatment |
15; 2; 8 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00690560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.