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

NCT ID: NCT02486952

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 154 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2011-01-31

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cyclophosphamide

Intervention Type: DRUG

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.

Hydroxydaunorubicin

Intervention Type: DRUG

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.

Oncovin

Intervention Type: DRUG

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.

Prednisone

Intervention Type: DRUG

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.

Rituximab

Intervention Type: DRUG

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.

Interventions

Cyclophosphamide

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.

Intervention Type: DRUG

Hydroxydaunorubicin

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.

Intervention Type: DRUG

Oncovin

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.

Intervention Type: DRUG

Prednisone

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.

Intervention Type: DRUG

Rituximab

Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.

Intervention Type: DRUG

Other Intervention Names

MabThera

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Serbian Lymphoma Group

UNKNOWN

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Belgrade, , Serbia

Belgrade, , Serbia

Kamenitz, , Serbia

Kragujevac, , Serbia

Niš, , Serbia

Countries

Serbia

Other Identifiers

ML20390

Identifier Type: -

Identifier Source: org_study_id