Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma Clinical Trial
Official title:
Open, Non-Interventional, Multicenter Trial of MabThera in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma
| Verified date | January 2016 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Serbia: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 154 |
| Est. completion date | January 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche | Serbian Lymphoma Group |
Serbia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Probability of Event Free Survival (EFS) | 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. | Up to 41 months | No |
| Secondary | Percentage of Participants Who Were Alive | Percentage of participants with survival was calculated 41 months after the first dose of study treatment. | Up to 41 months | No |