HU-F-AIM - A prospective, interventional study to evaluate HU-resistance in polycythemia vera patients who meet predictive parameters identified in the machine learning project PV-AIM

Conditions

Polycythemia vera

Brief summary

Proportion of PV patients with HU-resistance/intolerance within 6-9 months after start of de novo HU- treatment in presence of the PV-AIM HU-resistance predictors at the start of HU treatment.

Detailed description

Proportion of PV patients who meet the PV-AIM HU-resistance predictors before start of HU-treatment, Proportion of patients developing HU resistance/intolerance at any time within the maximum treatment period of 15 months, Proportion of patients developing HU resistance/intolerance at any time within the maximum treatment period of 15 months in presence or absence of the PV-AIM HU-resistance predictors at start of HU treatment., For all patients who develop HU resistance/intolerance according to (European LeukemiaNet) ELN criteria at any time during the maximum treatment period of 15 months • Proportion of “non-switchers” (i.e., patients remaining on HU despite they meet the HU-resistance/intolerance criteria) compared to “switchers” • Timepoint of therapy switch (after confirmation of HU resistance/intolerance) • Reasons for therapy switch / non-switch • Therapies applied during follow-up period

Related papers

No related papers found yet.

Interventions

DRUGHYDROXYCARBAMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of PV patients with HU-resistance/intolerance within 6-9 months after start of de novo HU- treatment in presence of the PV-AIM HU-resistance predictors at the start of HU treatment.	—

Secondary

Measure	Time frame
Proportion of PV patients who meet the PV-AIM HU-resistance predictors before start of HU-treatment, Proportion of patients developing HU resistance/intolerance at any time within the maximum treatment period of 15 months, Proportion of patients developing HU resistance/intolerance at any time within the maximum treatment period of 15 months in presence or absence of the PV-AIM HU-resistance predictors at start of HU treatment., For all patients who develop HU resistance/intolerance according to (European LeukemiaNet) ELN criteria at any time during the maximum treatment period of 15 months • Proportion of “non-switchers” (i.e., patients remaining on HU despite they meet the HU-resistance/intolerance criteria) compared to “switchers” • Timepoint of therapy switch (after confirmation of HU resistance/intolerance) • Reasons for therapy switch / non-switch • Therapies applied during follow-up period	—

Measure

Time frame

Proportion of PV patients who meet the PV-AIM HU-resistance predictors before start of HU-treatment, Proportion of patients developing HU resistance/intolerance at any time within the maximum treatment period of 15 months, Proportion of patients developing HU resistance/intolerance at any time within the maximum treatment period of 15 months in presence or absence of the PV-AIM HU-resistance predictors at start of HU treatment., For all patients who develop HU resistance/intolerance according to (European LeukemiaNet) ELN criteria at any time during the maximum treatment period of 15 months • Proportion of “non-switchers” (i.e., patients remaining on HU despite they meet the HU-resistance/intolerance criteria) compared to “switchers” • Timepoint of therapy switch (after confirmation of HU resistance/intolerance) • Reasons for therapy switch / non-switch • Therapies applied during follow-up period

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Countries

Germany

Outcome results

None listed