CASPER-ATG-IPC 2023-015 : Reinforced prophylaxis of GVH in elderly patients with haematological malignancies receiving haploidentical allogenic hematopoietic stem cell transplantation: use of a low dose of post-allograft anti-lymphocytic serum.

Phase 1

• Conditions: haematological malignancies; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-506648-18-00
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-05
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

adult with age = 60 or aged 50 to 59 with comorbidities (HCT-CI10 score = 3), haematological malignancies except for myeloproliferative syndrome and myelodysplastic syndrome, 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)., Patient discharged from aplasia within = 35 days, Signed informed Consent form, affiliation with a social security

Exclusion Criteria

previous allogeneic transplant or organ transplant, presence of GVH, contraindication 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, Person in an emergency situation 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess efficacy of enhanced GVH prophylaxis with low-dose ATG administered at the time of neutrophil recovery after haplo-identical allogeneic transplantation.;Secondary Objective: -To assess the impact of enhanced GVH prophylaxis with low-dose ATG administered at the time of neutrophil recovery after haploidentical allogeneic transplantation on : •Tolerance to early post-transplant ATG •Engraftment •Immunological recovery after haploidentical allograft •Post-transplantation infections •Relapse of underlying hematologic malignancy •Progression-free survival at 1 year post-transplant •Overall survival at 1 year post-transplant •Quality of life, - To assess the impact of pre-transplant oncogeriatric evaluation on post-transplant outcome;Primary end point(s): Evaluate the rate of grade 2-4 acute GVH at D100 post allograft using the MAGIC7 classification.