Clinical trial NCT02486952: MabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma
Official title: Open, Non-Interventional, Multicenter Trial of MabThera in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Serbian Lymphoma Group
First posted: 2015-07-01
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with aggressive B-cell lymphoma (Diffuse Large B-Cell Lymphoma \[DLBCL\])

Brief 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 \< 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

Primary outcomes:
measure: Probability of Event Free Survival (EFS)
timeFrame: Up to 41 months
Secondary outcomes:
measure: Percentage of Participants Who Were Alive
timeFrame: Up to 41 months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: NIS
country: Serbia
city: Sremska Kamenica
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: