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

Phase 2

Not yet recruiting

• Conditions: Hematological Malignancy

• Registration Number: NCT06066255
• Lead Sponsor: Institut Paoli-Calmettes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-09-27
• Study First Posted: 2023-10-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Study Start: 2024-03-31
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of acute GVH	Day 100	To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification.

Secondary Outcome Measures

Name	Time	Method
Survival	1 year	Progression-free survival and overall survival at 1 year post-transplant,
Cumulative incidence of chronic GVH	1 year	Cumulative incidence of chronic GVHD at 1 year post-transplant,
Cumulative incidence of relapse	1 year	Cumulative incidence of relapse at 1 year post-transplant,
chronic GVH	day(D)100, D120, D180, D270 and D365	Chronic GVHD will be assessed using NIH classification post allograft,
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
Cumulative incidence of NRM	1 year	Cumulative incidence of NRM at 1 year post-transplant,
Immunology	day(D)100, D120, D180, D270 and D365	Blood T, B and NK lymphocyte counts post-transplant,
Cumulative incidence	Day 100	Cumulative incidence of EBMT-defined "poor graft function" post-transplant.
Viral infections	between day (D)30 and D120	Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) post allograft,