Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Conditions
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.
Interventions
DRUGCyclophosphamide
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
DRUGOncovin
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
DRUGPrednisone
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
DRUGRituximab
Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
Sponsors
Serbian Lymphoma Group
Hoffmann-La Roche
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probability of Event Free Survival (EFS) | Up to 41 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were Alive | Up to 41 months | Percentage of participants with survival was calculated 41 months after the first dose of study treatment. |
Countries
Serbia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diffuse Large B-Cell Lymphoma Participants, who were not treated previously for DLBCL, and received rituximab in combination with 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 were 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. | 151 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 15 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Lost to Follow-up | 26 |
| Overall Study | Not Started Induction Therapy | 3 |
| Overall Study | Other | 2 |
Baseline characteristics
| Characteristic | Diffuse Large B-Cell Lymphoma |
|---|---|
| Age, Continuous | 58 years |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 151 |
| serious Total, serious adverse events | 25 / 151 |
Outcome results
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.
Time frame: Up to 41 months
Population: Full analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diffuse Large B-Cell Lymphoma | Probability of Event Free Survival (EFS) | 0.695 probability of EFS |
Secondary
Percentage of Participants Who Were Alive
Percentage of participants with survival was calculated 41 months after the first dose of study treatment.
Time frame: Up to 41 months
Population: Full analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diffuse Large B-Cell Lymphoma | Percentage of Participants Who Were Alive | 74.4 percentage of participants |