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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

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