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Table 1 Study calendar

From: Phase I study of an active immunotherapy for asymptomatic phase Lymphoplasmacytic lymphoma with DNA vaccines encoding antigen-chemokine fusion: study protocol

Data Collection Instrument Screening Eligibility Baseline Vaccine 1 Vaccine 2 Vaccine 3 Post Vaccine Follow-up 1 Post Vaccine Follow-up 2 Blood Work 1 Post Vaccine Follow-up 3 Post Vaccine Follow-up 4 Blood Work 2 Post Vaccine Follow-up 5 Post Vaccine Follow-up 6 Blood Work 3 Post Vaccine Follow-up 7 Blood Work 4 End of Study/Progression
Study ID & ICF Information X                 
Demographics X                 
Screening Eligibility X                 
H&P, Vitals, ECOG X X X X X X X X X X X X X X X X X
Physical Exam X X X X X X X X X X X X X X X X X
Concomitant Medications X                 
Chemistries X X X X X X X   X X   X X   X   X
Hematology, PT/PTT X X X X X X X   X X   X X   X   X
Lymphoma Labs Serum X X X X X X X   X X   X X   X   X
Lymphoma Labs Urine X X X X X X X   X X   X X   X   X
ANA ds DNA X X X X X X X   X X   X X   X   X
Infectious Disease Panel X                 
EKG/Imaging X X                
Bone Marrow Biopsy X                 
Vaccine Therapy    X X X             
Disease Assessment     X X X X   X X   X X   X   X
Correlative Lab Draw X   X X X X   X    X    X   X X
Off Study Evaluation    X X X X X X X X X X X X X X X
Long term follow-up                  X
AE/SAE CTCAE v4   X X X X X X X X X X X X X X X X