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

Study Overview
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Brief Summary
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The aim of this trial is to evaluate the efficacy of GVH prophylaxis reinforced by low-dose Thymoglobulin administered at the end of aplasia after haploidentical allogeneic transplantation. Patients will receive a single infusion of Thymoglobulin at a dose of 1 mg/kg between 48h and 72h after emergence from aplasia, and will be followed for 12 months.

Official Title
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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
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Hematological Malignancy

Intervention / Treatment
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* Drug: Thymoglobulin Injectable Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged ≥ 60 or aged 50 to 59 with comorbidities (HCT-CI10 score ≥ 3), Hematological malignancies except myeloproliferative syndrome and myelodysplastic syndrome, Patient having received an allograft within ≤ 35 days, performed with the following modalities: First allogeneic transplant, Haploidentical donor, Peripheral stem cell transplant, Non-myeloablative Baltimore-type conditioning, delivered as standard in routine care, as reported in the literature (fludarabine, cyclophosphamide, total body irradiation), Standard GVHD prophylaxis in the context of haploidentical transplants (post-transplant cyclophosphamide, ciclosporin A and mycophenolate mofetil). Patient discharged from aplasia within ≤ 35 days, Signed informed consent form, Affiliation with a social security. Exclusion Criteria: Previous allogeneic or organ transplant, Presence of signs of GVHD, Contraindications to treatment with Thymoglobuline®, Hypersensitivity to rabbit proteins or to any of the excipients listed in the Composition section of the summary of product characteristics, Pregnant women or may become pregnant (without effective contraception) or breast-feeding, Persons in emergency situations or unable to give informed consent form, Adult with a legal protection measure (adult under guardianship, curatorship or safeguard of justice), Unable to comply with medical follow-up for geographical, social or psychological reasons.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thymoglobulin Injectable Product|single intravenous injection of thymoglobulin|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of acute GVH | To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification. | Day 100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute GVH | Grade 2-4 acute GVHD will be assessed using the MAGIC classification post allograft | day(D) 30, D60, D90, D100, D120, D180, D270 and D365 | 
| chronic GVH | Chronic GVHD will be assessed using NIH classification post allograft, | day(D)100, D120, D180, D270 and D365 | 
| Cumulative incidence of chronic GVH | Cumulative incidence of chronic GVHD at 1 year post-transplant, | 1 year | 
| Cumulative incidence of NRM | Cumulative incidence of NRM at 1 year post-transplant, | 1 year | 
| Cumulative incidence of relapse | Cumulative incidence of relapse at 1 year post-transplant, | 1 year | 
| Immunology | Blood T, B and NK lymphocyte counts post-transplant, | day(D)100, D120, D180, D270 and D365 | 
| Viral infections | Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) post allograft, | between day (D)30 and D120 | 
| Cumulative incidence | Cumulative incidence of EBMT-defined poor graft function post-transplant. | Day 100 | 
| Survival | Progression-free survival and overall survival at 1 year post-transplant, | 1 year |