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

Hematological Malignancy Clinical Trial

— CASPER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06066255
• Other study ID #: CASPER-ATG-IPC 2023-015
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 31, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2024
• Source: Institut Paoli-Calmettes
• Contact: Jihane PAKRADOUNI
• Phone: +33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Neoplasms

Intervention

Drug:
• Thymoglobulin Injectable Product
single intravenous injection of thymoglobulin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	Sanofi

Outcome

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