Status:
UNKNOWN
Evaluation of EFficacy and SaFEty of Leukotac (Inolimomab) in Pediatric Patients With SR-aGvHD
Lead Sponsor:
ElsaLys Biotech
Conditions:
Steroid Refractory GVHD
Eligibility:
All Genders
28-18 years
Phase:
PHASE3
Brief Summary
A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)
Eligibility Criteria
Inclusion
- Patients who develop a first episode of aGvHD stage ≥ II (Przepiorka et al., 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose)
- Age 28 days to \< 18 years old
- Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
- Patients receiving Allo-HSCT for any indication (i.e. malignant or non-malignant disease)
- Signature of informed and written consent by the patient and/or by the patient's legally acceptable representative(s)
Exclusion
- Isolated stage 1 skin SR-aGvHD
- Overlap chronic GvHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
- Acute GvHD after donor lymphocytes infusion (DLI)
- Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
- Other systemic drugs than corticosteroids for GvHD treatment (including extra-corporeal photopheresis). Drugs already being used for GvHD prevention (e.g. calcineurin inhibitors) are allowed.
- Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- Known allergy or intolerance to Leukotac of one of its ingredients
- Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female and male of childbearing potential
- Other ongoing interventional protocol that might interfere with
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04289103
Start Date
October 1 2021
End Date
June 1 2024
Last Update
December 17 2020
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