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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Aug 31, 2005

Status verified

Jan 2016

Primary completion

Jan 31, 2011

Completion

Jan 31, 2011

Study Design

Enrollment

154 participants (actual)

Arms

• Arm: 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.

Primary Outcome Measure

Probability of Event Free Survival (EFS) [ Time Frame: Up to 41 months ]