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Completed

NCT Number: NCT02486952

MabThera (Rituximab) 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.

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Key information

Conditions

Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Belgrade, Serbia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

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

Hydroxydaunorubicin

Drug

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

Oncovin

Drug

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

Prednisone

Drug

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

Rituximab

Drug

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

Primary outcomes

  1. Probability of Event Free Survival (EFS)

    Time frame: Up to 41 months

    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.

Secondary outcomes

  1. Percentage of Participants Who Were Alive

    Time frame: Up to 41 months

    Percentage of participants with survival was calculated 41 months after the first dose of study treatment.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Serbian Lymphoma Group

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jul 1, 2015
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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