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

NCT ID: NCT06066255

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2026-03-31

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 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.

Conditions

Hematological Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Thymoglobulin Injectable Product

single intravenous injection of thymoglobulin

Intervention Type: DRUG

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jihane PAKRADOUNI

Role: CONTACT

drci.up@ipc.unicancer.fr

+33491223778

Other Identifiers

CASPER-ATG-IPC 2023-015

Identifier Type: -

Identifier Source: org_study_id