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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Paoli-Calmettes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 Jan 2025 → ongoing

Decision date (initial)

2024-06-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

GIRCI (PHRC-I) · Sanofi

External identifiers

EU CT number

2023-506648-18-00

WHO UTN

U1111-1294-6927

ClinicalTrials.gov

NCT06066255

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To assess efficacy of enhanced GVH prophylaxis with low-dose ATG administered at the time of neutrophil recovery after haplo-identical allogeneic transplantation.

Secondary objectives 2

1. - 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
2. - To assess the impact of pre-transplant oncogeriatric evaluation on post-transplant outcome

Conditions and MedDRA coding

haematological malignancies

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 8

1. previous allogeneic transplant or organ transplant
2. presence of GVH
3. contraindication to treatment with thymoglobuline
4. Hypersensitivity to rabbit proteins or to any of the excipients listed in the “Composition” section of the summary of product characteristics
5. pregnant women or may become pregnant (without effective contraception) or breast-feeding
6. Person in an emergency situation or unable to give informed consent form
7. Adult with a legal protection measure (adult under guardianship, curatorship or safeguard of justice)
8. Unable to comply with medical follow-up for geographical, social or psychological reasons

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Evaluate the rate of grade 2-4 acute GVH at D100 post allograft using the MAGIC7 classification.

Secondary endpoints 11

1. Grade 2-4 acute GVH will be assessed using the MAGIC7 classification at D30, D60, D90, D100, D120, D180, D270 and at D365 post allograft
2. Chronic GVH will be assessed using NIH8 classification at D100, D120, D180, D270 and at D365 post allograft
3. Cumulative incidence of chronic GVH at 1 year post-transplant
4. Cumulative incidence of non-relapse mortality (NRM) at 1 year post-transplant
5. Cumulative incidence of relapse at 1 year post-transplant
6. Blood T, B and NK lymphocyte counts at D30, D60, D90, D120 and D180 post-transplant
7. Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) between D30 and D120 post allograft
8. Cumulative incidence of EBMT-defined "poor graft function" at D100 post-transplant
9. Progression-free survival at 1 year post-transplant
10. Overall survival at 1 year post-transplant
11. Quality of life: assessed using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Paoli-Calmettes

Sponsor organisation

Institut Paoli-Calmettes

Address

232 Boulevard De Sainte Marguerite, Bp 156 Bp 156

City

Marseille

Postcode

13009

Country

France

Scientific contact point

Organisation

Institut Paoli-Calmettes

Contact name

Dr Benjamin BOUCHACOURT

Public contact point

Organisation

Institut Paoli-Calmettes

Contact name

Mme LAROSA Marina

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications