Rabbit anti-human thymocyte immunoglobulin for Haematological malignancies

Inclusion criteria

• {"criterion_text":"- adult with age ≥ 60 or aged 50 to 59 with comorbidities (HCT-CI10 score ≥ 3)\n- haematological malignancies except for myeloproliferative syndrome and myelodysplastic syndrome\n- Patient having received an allograft within ≤ 35 days, performed with the following modalities: o First allogeneic transplant, o Haploidentical donor, o Peripheral stem cell transplant, o Non-myeloablative \"Baltimore\"-type conditioning, delivered as standard in routine care, as reported in the literature (fludarabine, cyclophosphamide, total body irradiation), o Standard GVH prophylaxis in the context of haploidentical transplants (post-transplant cyclophosphamide, ciclosporin A and mycophenolate mofetil).\n- Patient discharged from aplasia within ≤ 35 days\n- Signed informed Consent form\n- affiliation with a social security"}

Exclusion criteria

• {"criterion_text":"- previous allogeneic transplant or organ transplant\n- presence of GVH\n- contraindication to treatment with thymoglobuline\n- Hypersensitivity to rabbit proteins or to any of the excipients listed in the “Composition” section of the summary of product characteristics\n- pregnant women or may become pregnant (without effective contraception) or breast-feeding\n- Person in an emergency situation or unable to give informed consent form\n- Adult with a legal protection measure (adult under guardianship, curatorship or safeguard of justice)\n- Unable to comply with medical follow-up for geographical, social or psychological reasons"}

Primary endpoints

• {"endpoint_text":"- Evaluate the rate of grade 2-4 acute GVH at D100 post allograft using the MAGIC7 classification.","definition_or_measurement_approach":"Assessment at D100 post allograft using the MAGIC7 classification to determine rate of grade 2-4 acute GVH."}

Secondary endpoints

• {"endpoint_text":"- Grade 2-4 acute GVH will be assessed using the MAGIC7 classification at D30, D60, D90, D100, D120, D180, D270 and at D365 post allograft\n- Chronic GVH will be assessed using NIH8 classification at D100, D120, D180, D270 and at D365 post allograft\n- Cumulative incidence of chronic GVH at 1 year post-transplant\n- Cumulative incidence of non-relapse mortality (NRM) at 1 year post-transplant\n- Cumulative incidence of relapse at 1 year post-transplant\n- Blood T, B and NK lymphocyte counts at D30, D60, D90, D120 and D180 post-transplant\n- Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) between D30 and D120 post allograft\n- Cumulative incidence of EBMT-defined \"poor graft function\" at D100 post-transplant\n- Progression-free survival at 1 year post-transplant\n- Overall survival at 1 year post-transplant\n- Quality of life: assessed using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire.","definition_or_measurement_approach":"Endpoints measured at specified post-allograft days using stated classifications and instruments: MAGIC7 for acute GVH at listed timepoints; NIH8 for chronic GVH at listed timepoints; cumulative incidence measures at 1 year post-transplant; lymphocyte counts measured at listed days; infections measured between D30 and D120 for specified pathogens; \"poor graft function\" per EBMT definition at D100; PFS and OS at 1 year; QoL assessed using FACT-BMT questionnaire."}

France

Earliest CTIS Part Ii Submission Date

28-05-2024

Latest Decision Or Authorization Date

04-12-2025

Processing Time Days

555

Number Of Sites

1

Number Of Participants

27

Primary sponsor

Full Name

Institut Paoli-Calmettes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France