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

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Hydroxydaunorubicin; Drug: Oncovin; Drug: Prednisone; Drug: Rituximab

• Study Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
  • Belgrade, Serbia, 11070
  • Kragujevac, Serbia, 34000
  • NIS, Serbia, 18000
  • Sremska Kamenica, Serbia, 21204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with aggressive B-cell lymphoma (Diffuse Large B-Cell Lymphoma [DLBCL])

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Diffuse Large B-Cell Lymphoma (DLBCL); 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; Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.; Drug: Hydroxydaunorubicin; Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.; Drug: Oncovin; Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.; Drug: Prednisone; Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.; Drug: Rituximab; Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.; Other Names: MabThera

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Serbian Lymphoma Group

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Estimate): February 22, 2016
• Last Update Submitted That Met QC Criteria: January 22, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Antibiotics, Antineoplastic; Cyclophosphamide; Rituximab; Prednisone; Doxorubicin; Liposomal doxorubicin; Vincristine
• Other Study ID Numbers: ML20390