Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma
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.
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Radiation: yttrium Y 90 ibritumomab tiuxetan
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Event-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: up to one year ] [ Designated as safety issue: No ]
- Relapse-free survival in responding patients [ Time Frame: up to one year ] [ Designated as safety issue: No ]
- Rate of disease progression [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: up to six months ] [ Designated as safety issue: No ]
- Toxicities [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
|Experimental: R-CHOP14 chemotherapy||Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: yttrium Y 90 ibritumomab tiuxetan|
- Determine event-free survival of patients with large B-cell lymphoma treated with CHOP-R followed by consolidation therapy.
- Determine overall survival.
- Evaluate relapse-free survival for patients achieving complete or partial response.
- Determine the rate of disease progression.
- Determine response rate at the end of study therapy.
- Assess the toxicities of this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive the CHOP-R regimen comprising doxorubicin hydrochloride IV, vincristine IV, cyclophosphamide IV, and rituximab IV on day 1 and prednisone IV on days 1-5. Treatment repeats every 2 weeks for 2 courses.
Patients who achieve complete or partial response, as assessed by PET/CT scan, receive a third course of induction therapy.
- Consolidation therapy: Patients receive rituximab IV on days -8 to 0 and yttrium Y 90 ibritumomab tiuxetan IV on day 0.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690560
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Study Chair:||Frederec Peyrade, MD||Centre Antoine Lacassagne|