essential thrombocythemia, polycythemia vera
Conditions
Brief summary
The rate of complete clinicohematologic responses (CHR) at month 6, compared to baseline, as defined by (Barosi, et al., 2009).
Detailed description
Safety of both regimens., The rate of complete clinicohematologic responses (CHR) at month 12 and month 24 as defined by Barosi et al. Blood 2009 (with the clinical modification that splenomegaly assessment may be done by ultrasound or palpation)., To determine the complete response (CR) rate at month 6 as defined by Barosi et al. Blood 2013 (revised ELN response criteria, see section 15.6) (Barosi, et al., 2013)., The efficacy as assessed by both the absence of phlebotomy (Hct <45%) and reduction in spleen size (palpable spleen that is reduced by > 50% from baseline measured by palpation or ultrasound) OR platelet count < 600 x 10^9/l (ET) at month 6 and month 24, The proportion of subjects achieving both durable absence of phlebotomy eligibility and durable spleen size reduction measured by palpation (PV) OR durable platelet count < 600 x 10^9/l (ET) (durable defined as > 3 months) (Barosi et al. 2009/2013) at month 6, month 12 and month 24., The rate of overall clinicohematologic responses (CR + PR) according to both guidelines (Barosi et al. 2009 and 2013) at month 6 and month 24.
Interventions
Sponsors
Universitaetsklinikum Aachen AöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of complete clinicohematologic responses (CHR) at month 6, compared to baseline, as defined by (Barosi, et al., 2009). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of both regimens., The rate of complete clinicohematologic responses (CHR) at month 12 and month 24 as defined by Barosi et al. Blood 2009 (with the clinical modification that splenomegaly assessment may be done by ultrasound or palpation)., To determine the complete response (CR) rate at month 6 as defined by Barosi et al. Blood 2013 (revised ELN response criteria, see section 15.6) (Barosi, et al., 2013)., The efficacy as assessed by both the absence of phlebotomy (Hct <45%) and reduction in spleen size (palpable spleen that is reduced by > 50% from baseline measured by palpation or ultrasound) OR platelet count < 600 x 10^9/l (ET) at month 6 and month 24, The proportion of subjects achieving both durable absence of phlebotomy eligibility and durable spleen size reduction measured by palpation (PV) OR durable platelet count < 600 x 10^9/l (ET) (durable defined as > 3 months) (Barosi et al. 2009/2013) at month 6, month 12 and month 24., The rate of overall clinicohematologic re | — |
Countries
Germany
Outcome results
None listed