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

NCT06066255 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CASPER-ATG-IPC 2023-015
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Rate of acute GVH

  To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification.

  Day 100

Secondary Outcomes (9)

• Acute GVH

  day(D) 30, D60, D90, D100, D120, D180, D270 and D365

• chronic GVH

  day(D)100, D120, D180, D270 and D365

• Cumulative incidence of chronic GVH

  1 year

• Cumulative incidence of NRM

  1 year

• Cumulative incidence of relapse

  1 year

Interventions

Thymoglobulin Injectable Product DRUG

single intravenous injection of thymoglobulin

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead
• Sanofi: collaborator

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Jihane PAKRADOUNI

CONTACT

+33491223778; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: March 31, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share