PROPHYLAXIS OF GVH IN ELDERLY PATIENTS RECEIVING HAPLOIDENTICAL ALLOGENIC HEMATOPOIETIC STEM CELL TRASNPLANTATION USE OF A LOW DOSE ANTI-LYMPHOCYTIC SERUM

• Status: Not yet recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Paoli-Calmettes
• Collaborator: Sanofi
• Treatments: Thymoglobulin

Criteria

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.