Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Hydroxydaunorubicin | Drug | Doxorubicin | ALIAS |
| Oncovin | Drug | Vincristine | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Diffuse Large B-Cell Lymphoma (DLBCL)
- description
- 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.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Hydroxydaunorubicin
- Drug: Oncovin
- Drug: Prednisone
- Drug: Rituximab
Primary outcomes (1)
- measure
- Probability of Event Free Survival (EFS)
- timeFrame
- Up to 41 months
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available