MabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma

Study Overview
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Brief Summary
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Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Participants, who were not treated previously for DLBCL, will receive MabThera in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy according to registered indication. Patients will be followed up for safety and efficacy evaluation in accordance with routine practice. The study will be non-interventional and by its design purely observational. All treatments prescribed during the observation period will be at the treating physician's discretion and will be prescribed according to package labeling, within approved indication and local approval status of respective drugs.

Official Title
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Open, Non-Interventional, Multicenter Trial of MabThera in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma

Conditions
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Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: Hydroxydaunorubicin
* Drug: Oncovin
* Drug: Prednisone
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed cluster of differentiation antigen 20 (CD20) positive Diffuse Large B-Cell Lymphoma according to the World Health Organization/Revised European-American Classification of Lymphoid Neoplasms (WHO/REAL) classification Age > or =18 years Performance status < or = 2 on the Eastern Cooperative Oncology Group (ECOG) scale Women of child-bearing potential must agree to use effective contraception for the entire treatment period and during the 12 months thereafter Exclusion Criteria: Transformed lymphoma (secondary to low-grade follicular lymphoma) Grade 1, 2 or 3a follicular lymphoma Primary or secondary central nervous system (CNS) involvement Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer Major surgery (excluding lymph node biopsy) within 28 days prior to registration. Poor renal function: Serum creatinine > 2.0 mg/dl (177 micromol/L) Pregnancy Poor hepatic function: total bilirubin > 2.0 mg/dl (34 micromol/L), aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]) or alkaline phosphatase (AP) > 3 x the upper limit of normal unless these abnormalities are related to lymphoma. Known human immunodeficiency virus (HIV) infection or active viral hepatitis, specifically hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial Life expectancy < 6 months Known sensitivity or allergy to murine products Treatment within a clinical trial within 30 days prior to trial entry

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diffuse Large B-Cell Lymphoma (DLBCL)<br>Participants, who were not treated previously for DLBCL, will receive rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants will be followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason. | Drug: Cyclophosphamide<br>* Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.<br>Drug: Hydroxydaunorubicin<br>* Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.<br>Drug: Oncovin<br>* Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.<br>Drug: Prednisone<br>* Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.<br>Drug: Rituximab<br>* Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.<br>* Other names: MabThera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of Event Free Survival (EFS) | EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression. | Up to 41 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Were Alive | Percentage of participants with survival was calculated 41 months after the first dose of study treatment. | Up to 41 months |