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

NCT02486952 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 154

Last updated 2016-02-22

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Serbia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02486952 on ClinicalTrials.gov