N/A
N=154
MabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma
Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02486952 ↗Enrolled (actual)
154
Serious AEs
16.6%
Results posted
Feb 2016
Primary outcome: Primary: Probability of Event Free Survival (EFS) — 0.695 probability of EFS
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cyclophosphamide (Drug); Hydroxydaunorubicin (Drug); Oncovin (Drug); Prednisone (Drug); Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probability of Event Free Survival (EFS) |
0.695 | — |
| SECONDARY Percentage of Participants Who Were Alive |
74.4 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT02486952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.