Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine event-free survival of patients with large B-cell lymphoma treated with CHOP-R followed by consolidation therapy. Secondary 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.

Official Title
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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

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: rituximab
* Drug: cyclophosphamide
* Drug: doxorubicin hydrochloride
* Drug: prednisone
* Drug: vincristine sulfate
* Radiation: yttrium Y 90 ibritumomab tiuxetan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-CHOP14 chemotherapy<br> | Biological: rituximab<br> <br> Drug: cyclophosphamide<br> <br> Drug: doxorubicin hydrochloride<br> <br> Drug: prednisone<br> <br> Drug: vincristine sulfate<br> <br> Radiation: yttrium Y 90 ibritumomab tiuxetan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | up to one year | 
| Relapse-free survival in responding patients |  | up to one year | 
| Rate of disease progression |  | up to 2 years | 
| Response rate |  | up to six months | 
| Toxicities |  | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma