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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

Sponsor
Institut Paoli-Calmettes (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06066255
Collaborator
Sanofi (Industry)
27
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Thymoglobulin Injectable Product
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
27 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Mar 31, 2024
Anticipated Primary Completion Date :
Mar 31, 2026
Anticipated Study Completion Date :
Mar 31, 2026

Outcome Measures

Primary Outcome Measures

  1. Rate of acute GVH [Day 100]

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

Secondary Outcome Measures

  1. Acute GVH [day(D) 30, D60, D90, D100, D120, D180, D270 and D365]

    Grade 2-4 acute GVHD will be assessed using the MAGIC classification post allograft

  2. chronic GVH [day(D)100, D120, D180, D270 and D365]

    Chronic GVHD will be assessed using NIH classification post allograft,

  3. Cumulative incidence of chronic GVH [1 year]

    Cumulative incidence of chronic GVHD at 1 year post-transplant,

  4. Cumulative incidence of NRM [1 year]

    Cumulative incidence of NRM at 1 year post-transplant,

  5. Cumulative incidence of relapse [1 year]

    Cumulative incidence of relapse at 1 year post-transplant,

  6. Immunology [day(D)100, D120, D180, D270 and D365]

    Blood T, B and NK lymphocyte counts post-transplant,

  7. Viral infections [between day (D)30 and D120]

    Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) post allograft,

  8. Cumulative incidence [Day 100]

    Cumulative incidence of EBMT-defined "poor graft function" post-transplant.

  9. Survival [1 year]

    Progression-free survival and overall survival at 1 year post-transplant,

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institut Paoli-Calmettes
  • Sanofi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT06066255
Other Study ID Numbers:
  • CASPER-ATG-IPC 2023-015
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Thymoglobulin

Study Results

No Results Posted as of Oct 4, 2023