CASPER-ATG-IPC 2023-015 : Reinforced prophylaxis of GVH in elderly patients with haematological malignancies receiving haploidentical allogeneic hematopoietic stem cell transplantation: use of a low dose of post-allograft anti-lymphocytic serum.

Conditions

haematological malignancies

Brief summary

Evaluate the rate of grade 2-4 acute GVH at D100 post allograft using the MAGIC7 classification.

Detailed description

Grade 2-4 acute GVH will be assessed using the MAGIC7 classification at D30, D60, D90, D100, D120, D180, D270 and at D365 post allograft, Chronic GVH will be assessed using NIH8 classification at D100, D120, D180, D270 and at D365 post allograft, Cumulative incidence of chronic GVH at 1 year post-transplant, Cumulative incidence of non-relapse mortality (NRM) at 1 year post-transplant, Cumulative incidence of relapse at 1 year post-transplant, Blood T, B and NK lymphocyte counts at D30, D60, D90, D120 and D180 post-transplant, Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) between D30 and D120 post allograft, Cumulative incidence of EBMT-defined "poor graft function" at D100 post-transplant, Progression-free survival at 1 year post-transplant, Overall survival at 1 year post-transplant, Quality of life: assessed using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire.

Related papers

No related papers found yet.

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Interventions

DRUGTHYMOGLOBULINE 5 mg/ml

DRUGpoudre pour solution pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Evaluate the rate of grade 2-4 acute GVH at D100 post allograft using the MAGIC7 classification.	—

Secondary

Measure	Time frame
Grade 2-4 acute GVH will be assessed using the MAGIC7 classification at D30, D60, D90, D100, D120, D180, D270 and at D365 post allograft, Chronic GVH will be assessed using NIH8 classification at D100, D120, D180, D270 and at D365 post allograft, Cumulative incidence of chronic GVH at 1 year post-transplant, Cumulative incidence of non-relapse mortality (NRM) at 1 year post-transplant, Cumulative incidence of relapse at 1 year post-transplant, Blood T, B and NK lymphocyte counts at D30, D60, D90, D120 and D180 post-transplant, Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) between D30 and D120 post allograft, Cumulative incidence of EBMT-defined "poor graft function" at D100 post-transplant, Progression-free survival at 1 year post-transplant, Overall survival at 1 year post-transplant, Quality of life: assessed using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire.	—

Measure

Time frame

Grade 2-4 acute GVH will be assessed using the MAGIC7 classification at D30, D60, D90, D100, D120, D180, D270 and at D365 post allograft, Chronic GVH will be assessed using NIH8 classification at D100, D120, D180, D270 and at D365 post allograft, Cumulative incidence of chronic GVH at 1 year post-transplant, Cumulative incidence of non-relapse mortality (NRM) at 1 year post-transplant, Cumulative incidence of relapse at 1 year post-transplant, Blood T, B and NK lymphocyte counts at D30, D60, D90, D120 and D180 post-transplant, Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) between D30 and D120 post allograft, Cumulative incidence of EBMT-defined "poor graft function" at D100 post-transplant, Progression-free survival at 1 year post-transplant, Overall survival at 1 year post-transplant, Quality of life: assessed using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire.

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Countries

France

Outcome results

None listed