Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma

Study Overview
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Brief Summary
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Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL). The study is aimed to evaluate the overall response rate and the safety of four cycles of R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in newly diagnosed DLBCL patients with aged more than 70 years.

Detailed Description
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Four cycles of R-CHOP chemotherapy for the induction treatment [Dose intensity of CHOP chemotherapy is modulated according to Charlson Comorbidity Index (CCI)] If patients with CCI <1 Rituximab: 375 mg/m2, day 1 every 3 weeks. Conventional dose of CHOP chemotherapy repeat every 3 weeks. If patients with CCI ≥1 Rituximab: 375 mg/m2, day 1 every 3 weeks. 75% of conventional CHOP repeat every 3 weeks. Rituximab augmentation Rituximab: 375 mg/m2, every week x 4 times. Trimethoprim-sulfamethoxazole 1 tablet per day during augmentation

Official Title
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Phase II Trial of Rituximab (R) Augmentation Following R-CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone) Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma (DLBCL)

Conditions
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Lymphoma, Large B-cell, Diffuse

Intervention / Treatment
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* Drug: rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed CD20 positive DLBCL Age ≥ 70 Ann Arbor stage II, III and IV No prior chemotherapy or radiotherapy for DLBCL Performance status (Eastern Cooperative Oncology Group) ≤ 2 At least one or more bidimensionally measurable lesion(s) ≥ 2 cm by conventional computerized tomography (CT) ≥ 1 cm by spiral CT skin lesion (photographs should be taken) ≥ 2 cm measurable lesion by physical examination ≥ 2 cm Cardiac ejection fraction ≥ 50% as measured by echocardiogram without clinically significant abnormalities Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L) Adequate liver functions: Adequate bone marrow functions: hemoglobin ≥ 9 g/dL absolute neutrophil count ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma Life expectancy more than 6 months Informed consent Exclusion Criteria: Other subtypes of non-Hodgkin's lymphoma Patients who transformed follicular lymphoma or other indolent lymphoma Primary Central Nervous System (CNS) DLBCL CNS involvement by lymphoma or any evidence of spinal cord compression. Patients with a known history of human immunodeficiency virus (HIV) seropositivity or hepatitis C virus (+). Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri Pregnant or lactating women, women of childbearing potential not employing adequate contraception Other serious illness or medical conditions

Ages Eligible for Study
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Minimum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rituximab<br> | Drug: rituximab<br>* A dose of 375mg/m2 rituximab will be administered intravenously on day 1 of first to fourth R-CHOP chemotherapy and on day 1, 8, 15, 22 of each augmentation chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the overall response rate | To evaluate the objective overall response rate of four cycles of R-CHOP and followed by four times weekly rituximab augmentation in exteremely elderly patients with DLBCL. | three years after the completion of rituximab augmentation | 
| Number of patients with adverse events | All patients will be evaluated for the toxicity during the treatment. Toxicity is graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC v3.0). | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | Three years after the completion of rituximab augmentation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diffuse large B-cell lymphoma, elderly patients, rituximab augmentation