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

NCT06066255

UnknownPhase 2

Sponsor: Institut Paoli-Calmettes

Conditions: Hematological Malignancy

Interventions: Thymoglobulin Injectable Product

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.

Eligibility overview

Sex: ALL

Age: 60 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.