Table 1.

Eligibility criteria summarized across 24 first-line phase 3 clinical trials and 10 clinicaltrials.gov trials in follicular lymphoma

VariablesPhase 3 clinical trials, n (%)Phase 2-3 clinicaltrials.gov trials, n (%)
Stage/extent of disease 21 (88) 9 (90) 
Renal function 21 (88) 3 (30) 
HIV/AIDS status 20 (83) 6 (60) 
Performance status 19 (79) 7 (70) 
History of other malignancies 19 (79) 4 (40) 
Hepatic function 19 (79) 3 (30) 
Cardiac function 17 (71) 1 (10) 
Treatment required for disease 15 (63)  
Grade 14 (58)  
Pregnancy status 13 (54) 8 (80) 
Neuro/psych function 13 (54)  
Metabolic disease 12 (50)  
Birth control use 12 (50)  
Pulmonary function 12 (50)  
Self-reported serious medical conditions 12 (50) 5 (50) 
CNS involvement 11 (46)  
WBC requirement 11 (46)  
HBV status 10 (42) 3 (30) 
Platelet requirement 10 (42) 8 (80) 
Absence of FL transformation 10 (42)  
Measurable disease 9 (38)  
CD20 positivity 9 (38)  
HCV status 8 (33) 2 (20) 
Active infection status 8 (33) 3 (30) 
Life expectancy 8 (33)  
Breastfeeding status 8 (33)  
No concurrent trial registration 5 (21) 5 (50) 
Hemoglobin requirement 4 (17) 1 (10) 
On study within 3 mo of diagnosis 3 (13)  
No major surgery within 28 d 3 (13)  
Tissue diagnosis within 12 mo 2 (8)  
Histologic exam within 6 mo 1 (4)  
VariablesPhase 3 clinical trials, n (%)Phase 2-3 clinicaltrials.gov trials, n (%)
Stage/extent of disease 21 (88) 9 (90) 
Renal function 21 (88) 3 (30) 
HIV/AIDS status 20 (83) 6 (60) 
Performance status 19 (79) 7 (70) 
History of other malignancies 19 (79) 4 (40) 
Hepatic function 19 (79) 3 (30) 
Cardiac function 17 (71) 1 (10) 
Treatment required for disease 15 (63)  
Grade 14 (58)  
Pregnancy status 13 (54) 8 (80) 
Neuro/psych function 13 (54)  
Metabolic disease 12 (50)  
Birth control use 12 (50)  
Pulmonary function 12 (50)  
Self-reported serious medical conditions 12 (50) 5 (50) 
CNS involvement 11 (46)  
WBC requirement 11 (46)  
HBV status 10 (42) 3 (30) 
Platelet requirement 10 (42) 8 (80) 
Absence of FL transformation 10 (42)  
Measurable disease 9 (38)  
CD20 positivity 9 (38)  
HCV status 8 (33) 2 (20) 
Active infection status 8 (33) 3 (30) 
Life expectancy 8 (33)  
Breastfeeding status 8 (33)  
No concurrent trial registration 5 (21) 5 (50) 
Hemoglobin requirement 4 (17) 1 (10) 
On study within 3 mo of diagnosis 3 (13)  
No major surgery within 28 d 3 (13)  
Tissue diagnosis within 12 mo 2 (8)  
Histologic exam within 6 mo 1 (4)  
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