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Trial Title:
PROPHYLAXIS OF GVH IN ELDERLY PATIENTS RECEIVING HAPLOIDENTICAL ALLOGENIC HEMATOPOIETIC STEM CELL TRASNPLANTATION USE OF A LOW DOSE ANTI-LYMPHOCYTIC SERUM
NCT ID:
NCT06066255
Condition:
Hematological Malignancy
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Thymoglobulin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Thymoglobulin Injectable Product
Description:
single intravenous injection of thymoglobulin
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.
Criteria for 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.
Gender:
All
Minimum age:
60 Years
Maximum age:
100 Years
Healthy volunteers:
No
Start date:
March 31, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Institut Paoli-Calmettes
Agency class:
Other
Collaborator:
Agency:
Sanofi
Agency class:
Industry
Source:
Institut Paoli-Calmettes
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06066255
