Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
- Pharmacokinetic
Serum concentration (Cp). Measurement time: before each cycle of treatment and 3 months after the last cycle
Maximum concentration (AUC). Measurement time: before each cycle of treatment and 3 months after the last cycle
Half-life (t ½). Measurement time: before each cycle of treatment and 3 months after the last cycle
Plasma clearance (CL). Measurement time: before each cycle of treatment and 3 months after the last cycle
- Pharmacodynamic
- B cells depletion (Absolute counts of CD19+ in peripheral blood). Measurement time: before each cycle of treatment and 3 months after the last cycle
Key secondary outcomes:
Effect:
Clinical Response (standardized criteria for NHL: complete remission, unconfirmed complete response, partial remission, stable disease or progressive disease). Measurement time: 4 weeks after the last cycle of treatment
Safety:
Adverse events (AEs). Measurement time: 10 months
- Occurrence of an AE in the subject (yes / no)
- Description of AE (Name of adverse event)
- Duration of AE (difference between the start dates and completion of the event)
- Intensity AE (Mild, Moderate, Severe, Life-threatening or disabling, produces death)
- Gravity AE (Severe / serious, severe / not serious)
- Attitude to study treatment (unchanged, dose modification, temporary interruption or discontinuation of study treatment)
- Result of the AE (recovered, improved, persists or sequels)
- Causal relationship (1 Definitive, 2. Very Probable, 3. Probable, 4. Possible 5. Not related 6. Unknown)
Immunogenicity:
HACA Response (according OD title). Measurement time: before each cycle of treatment, 4 weeks post the last cycle of treatment and 3 months after the last cycle