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

Launched by INSTITUT PAOLI-CALMETTES · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment aimed at preventing a condition called graft-versus-host disease (GVHD) in older patients who are receiving a special type of stem cell transplant known as haploidentical allogeneic transplantation. GVHD can happen when the donated cells attack the patient's body, so the researchers want to see if a low dose of a medication called Thymoglobulin can help reduce this risk. Patients in this trial will receive one infusion of Thymoglobulin at a specific time after their transplant and will be monitored for 12 months to see how well it works.

To be eligible for this trial, participants must be adults aged 60 or older, or 50 to 59 with certain health conditions. They should have a type of blood cancer but not specific syndromes like myeloproliferative or myelodysplastic syndromes. Additionally, they must have recently received a haploidentical stem cell transplant and be recovering from a period of low blood cell counts (aplasia). If participants join the study, they can expect careful follow-up and support from the medical team throughout the trial. It's important to note that this trial is not yet recruiting participants, so there may be a wait before anyone can enroll.

Gender

ALL

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.