Hematological Malignancy
Conditions
Brief summary
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.
Interventions
single intravenous injection of thymoglobulin
Sponsors
Sanofi
Institut Paoli-Calmettes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of acute GVH | Day 100 | To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| chronic GVH | day(D)100, D120, D180, D270 and D365 | Chronic GVHD will be assessed using NIH classification post allograft, |
| Cumulative incidence of chronic GVH | 1 year | Cumulative incidence of chronic GVHD at 1 year post-transplant, |
| Cumulative incidence of NRM | 1 year | Cumulative incidence of NRM at 1 year post-transplant, |
| Cumulative incidence of relapse | 1 year | Cumulative incidence of relapse at 1 year post-transplant, |
| Acute GVH | day(D) 30, D60, D90, D100, D120, D180, D270 and D365 | Grade 2-4 acute GVHD will be assessed using the MAGIC classification post allograft |
| Viral infections | between day (D)30 and D120 | Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) post allograft, |
| Cumulative incidence | Day 100 | Cumulative incidence of EBMT-defined poor graft function post-transplant. |
| Survival | 1 year | Progression-free survival and overall survival at 1 year post-transplant, |
| Immunology | day(D)100, D120, D180, D270 and D365 | Blood T, B and NK lymphocyte counts post-transplant, |
Contacts
Primary ContactJihane PAKRADOUNI
Outcome results
None listed