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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 (CASPER)

Primary Purpose

Hematological Malignancy

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Thymoglobulin Injectable Product
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hematological Malignancy

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Acute GVH
    Grade 2-4 acute GVHD will be assessed using the MAGIC classification post allograft
    chronic GVH
    Chronic GVHD will be assessed using NIH classification post allograft,
    Cumulative incidence of chronic GVH
    Cumulative incidence of chronic GVHD at 1 year post-transplant,
    Cumulative incidence of NRM
    Cumulative incidence of NRM at 1 year post-transplant,
    Cumulative incidence of relapse
    Cumulative incidence of relapse at 1 year post-transplant,
    Immunology
    Blood T, B and NK lymphocyte counts post-transplant,
    Viral infections
    Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) post allograft,
    Cumulative incidence
    Cumulative incidence of EBMT-defined "poor graft function" post-transplant.
    Survival
    Progression-free survival and overall survival at 1 year post-transplant,

    Full Information

    First Posted
    September 27, 2023
    Last Updated
    September 27, 2023
    Sponsor
    Institut Paoli-Calmettes
    Collaborators
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06066255
    Brief 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
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 31, 2024 (Anticipated)
    Primary Completion Date
    March 31, 2026 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut Paoli-Calmettes
    Collaborators
    Sanofi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hematological Malignancy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    27 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Thymoglobulin Injectable Product
    Intervention Description
    single intravenous injection of thymoglobulin
    Primary Outcome Measure Information:
    Title
    Rate of acute GVH
    Description
    To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification.
    Time Frame
    Day 100
    Secondary Outcome Measure Information:
    Title
    Acute GVH
    Description
    Grade 2-4 acute GVHD will be assessed using the MAGIC classification post allograft
    Time Frame
    day(D) 30, D60, D90, D100, D120, D180, D270 and D365
    Title
    chronic GVH
    Description
    Chronic GVHD will be assessed using NIH classification post allograft,
    Time Frame
    day(D)100, D120, D180, D270 and D365
    Title
    Cumulative incidence of chronic GVH
    Description
    Cumulative incidence of chronic GVHD at 1 year post-transplant,
    Time Frame
    1 year
    Title
    Cumulative incidence of NRM
    Description
    Cumulative incidence of NRM at 1 year post-transplant,
    Time Frame
    1 year
    Title
    Cumulative incidence of relapse
    Description
    Cumulative incidence of relapse at 1 year post-transplant,
    Time Frame
    1 year
    Title
    Immunology
    Description
    Blood T, B and NK lymphocyte counts post-transplant,
    Time Frame
    day(D)100, D120, D180, D270 and D365
    Title
    Viral infections
    Description
    Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) post allograft,
    Time Frame
    between day (D)30 and D120
    Title
    Cumulative incidence
    Description
    Cumulative incidence of EBMT-defined "poor graft function" post-transplant.
    Time Frame
    Day 100
    Title
    Survival
    Description
    Progression-free survival and overall survival at 1 year post-transplant,
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominique GENRE
    Phone
    +33491223778
    Email
    drci.up@ipc.unicancer.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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

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