Status:
NOT_YET_RECRUITING
PROPHYLAXIS OF GVH IN ELDERLY PATIENTS RECEIVING HAPLOIDENTICAL ALLOGENIC HEMATOPOIETIC STEM CELL TRASNPLANTATION USE OF A LOW DOSE ANTI-LYMPHOCYTIC SERUM
Lead Sponsor:
Institut Paoli-Calmettes
Collaborating Sponsors:
Sanofi
Conditions:
Hematological Malignancy
Eligibility:
All Genders
60-100 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06066255
Start Date
March 31 2024
End Date
March 31 2026
Last Update
February 20 2024
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