FIBRAPLO - Haplo-identical transplantation in patients with myleofibrosis : A phase 2 prospective multicentric prospective study

Conditions

Myelofibrosis

Brief summary

The main criteria of judgement is disease- and rejection-free survival 12 months after HSCT.

Detailed description

incidence of acute grade 2-4 and grade 3-4 GVHD according to the modified Glucksberg classification, incidence of chronic GVHD (limited vs extensive) at 12 months according to the revised Seattle criteria, neutrophil engraftment on day 60 post-transplantation, engraftment is defined as neutrophil count at 0.5G/L or higher for more than 3 consecutive days after transplantation, it should be confirmed by a donor chimerism, latelet recovery: first day of platelet > 20G/L without transfusion the last 7 days assessed on day 100, overall survival at 12 months, on-relapse mortality at 12 months, incidence of relapse/progression at 12 months, incidence of rejection at 12 months, infection incidence at 100 days, 12 months (annexe for infection), cytokine profile during transplantation (day-7 +/- 1 jour, J0 and day J7 +/- 1 jour ), impact of genetic alterations on overall survival at 12 months and non-relapse mortality at 12 months

Related papers

No related papers found yet.

Interventions

DRUGTrecondi 1 g powder for solution for infusion

DRUGFLUDARABINE PHOSPHATE

DRUGTHIOTEPA

DRUGTrecondi 5 g powder for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The main criteria of judgement is disease- and rejection-free survival 12 months after HSCT.	—

Secondary

Measure	Time frame
incidence of acute grade 2-4 and grade 3-4 GVHD according to the modified Glucksberg classification, incidence of chronic GVHD (limited vs extensive) at 12 months according to the revised Seattle criteria, neutrophil engraftment on day 60 post-transplantation, engraftment is defined as neutrophil count at 0.5G/L or higher for more than 3 consecutive days after transplantation, it should be confirmed by a donor chimerism, latelet recovery: first day of platelet > 20G/L without transfusion the last 7 days assessed on day 100, overall survival at 12 months, on-relapse mortality at 12 months, incidence of relapse/progression at 12 months, incidence of rejection at 12 months, infection incidence at 100 days, 12 months (annexe for infection), cytokine profile during transplantation (day-7 +/- 1 jour, J0 and day J7 +/- 1 jour ), impact of genetic alterations on overall survival at 12 months and non-relapse mortality at 12 months	—

Measure

Time frame

incidence of acute grade 2-4 and grade 3-4 GVHD according to the modified Glucksberg classification, incidence of chronic GVHD (limited vs extensive) at 12 months according to the revised Seattle criteria, neutrophil engraftment on day 60 post-transplantation, engraftment is defined as neutrophil count at 0.5G/L or higher for more than 3 consecutive days after transplantation, it should be confirmed by a donor chimerism, latelet recovery: first day of platelet > 20G/L without transfusion the last 7 days assessed on day 100, overall survival at 12 months, on-relapse mortality at 12 months, incidence of relapse/progression at 12 months, incidence of rejection at 12 months, infection incidence at 100 days, 12 months (annexe for infection), cytokine profile during transplantation (day-7 +/- 1 jour, J0 and day J7 +/- 1 jour ), impact of genetic alterations on overall survival at 12 months and non-relapse mortality at 12 months

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Countries

France

Outcome results

None listed