The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.
Study Type
OBSERVATIONAL
Enrollment
99
Unnamed facility
Belgrade, Serbia
Unnamed facility
Belgrade, Serbia
Unnamed facility
Kamenitz, Serbia
Unnamed facility
Kragujevac, Serbia
Unnamed facility
Niš, Serbia
Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE
The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately.
Time frame: Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)
Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as greater than or equal to (≥) 50 percent (%) decrease in sum of the products of greatest diameters (SPD) of the six largest dominant lymph nodes, no increase in size of other nodes, no increase in liver or spleen volume, a ≥50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. The percentage of participants achieving CR or PR was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.
Time frame: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Percentage of Participants With CR According to International Working Group Response Criteria for NHL
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Unnamed facility
Novi Sad, Serbia
Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. The percentage of participants achieving CR was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.
Time frame: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Percentage of Participants Alive at 1, 2, and 3 Years
Participants were followed for survival for up to 3 years. The overall survival rate at 1, 2, and 3 years was calculated as \[number of participants alive divided by the number analyzed\] multiplied by 100.
Time frame: At 1, 2, and 3 years