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

REINFORCED PROPHYLAXIS OF GVH IN ELDERLY PATIENTS WITH HAEMATOLOGICAL MALIGNANCIES RECEIVING HAPLOIDENTICAL ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: USE OF A LOW DOSE OF POST-ALLOGRAFT ANTI-LYMPHOCYTIC SERUM

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hematological Malignancy
• Intervention / Treatment: Drug: Thymoglobulin Injectable Product

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jihane PAKRADOUNI; Phone Number: +33491223778; Email: drci.up@ipc.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of acute GVH	To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification.	Day 100

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute GVH	Grade 2-4 acute GVHD will be assessed using the MAGIC classification post allograft	day(D) 30, D60, D90, D100, D120, D180, D270 and D365
chronic GVH	Chronic GVHD will be assessed using NIH classification post allograft,	day(D)100, D120, D180, D270 and D365
Cumulative incidence of chronic GVH	Cumulative incidence of chronic GVHD at 1 year post-transplant,	1 year
Cumulative incidence of NRM	Cumulative incidence of NRM at 1 year post-transplant,	1 year
Cumulative incidence of relapse	Cumulative incidence of relapse at 1 year post-transplant,	1 year
Immunology	Blood T, B and NK lymphocyte counts post-transplant,	day(D)100, D120, D180, D270 and D365
Viral infections	Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) post allograft,	between day (D)30 and D120
Cumulative incidence	Cumulative incidence of EBMT-defined "poor graft function" post-transplant.	Day 100
Survival	Progression-free survival and overall survival at 1 year post-transplant,	1 year

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Thymoglobulin
• Other Study ID Numbers: CASPER-ATG-IPC 2023-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No