Clinical trial NCT06066255: PROPHYLAXIS OF GVH IN ELDERLY PATIENTS RECEIVING HAPLOIDENTICAL ALLOGENIC HEMATOPOIETIC STEM CELL TRASNPLANTATION USE OF A LOW DOSE ANTI-LYMPHOCYTIC SERUM
Official title: 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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hematological Malignancy
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2023-10-04
Enrollment: 27
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Rate of acute GVH
timeFrame: Day 100
Secondary outcomes:
measure: Acute GVH
timeFrame: day(D) 30, D60, D90, D100, D120, D180, D270 and D365
measure: chronic GVH
timeFrame: day(D)100, D120, D180, D270 and D365
measure: Cumulative incidence of chronic GVH
timeFrame: 1 year
measure: Cumulative incidence of NRM
timeFrame: 1 year
measure: Cumulative incidence of relapse
timeFrame: 1 year
measure: Immunology
timeFrame: day(D)100, D120, D180, D270 and D365
measure: Viral infections
timeFrame: between day (D)30 and D120
measure: Cumulative incidence
timeFrame: Day 100
measure: Survival
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: