Prospective Analysis of an individualized dosing Regimen of ATG (Thymoglobulin) in Children Undergoing HCT: redUcing Toxicity and improving Efficacy * a single arm phase II study

Prospective Analysis of an individualized dosing Regimen of ATG (Thymoglobulin) in Children Undergoing HCT: redUcing Toxicity and improving Efficacy * a single arm phase II study - Parachute trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47267

Enrollment

Registered

2015-01-26

Start date

2015-06-21

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individualised ATG dosing in standard of care in stem cell transplantion

Interventions

Patients receive an individualized dose of Thymoglobulin according to a PK/PD derived dosing regimen as opposed to a fixed standard dose of 10 mg/kg Thymoglobulin, the current standard of care.

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: * All patients eligible for a non-haplo-identical non-T-cell depleted HCT with Thymoglobulin as part of the conditioning regimen treated in the pediatric ward of the UMCU Utrecht or the LUMC Leiden * Any stem cell source * First transplantation * Age at time of transplantation

Exclusion criteria

Exclusion criteria: * Withdrawal of or no informed consent * No Thymoglobuline in conditioning regimen * Lansky / Karnofsky

Design outcomes

Primary

Measure	Time frame
Incidence of CD4+ T-cell immune reconstitution, defined as a CD4+ T-cell count > 50 x 10e6/L in 2 consecutive measurements within 100 days.	—

Secondary

Measure	Time frame
* Survival (overall survival, event free survival, non-relapse mortality, relapse mortality) * Relapse incidence * Incidence of viral reactivations (CMV, Adenovirus, EBV, HHV6, BK-virus) * Acute graft versus host disease (according to Glucksberg criteria) * Chronic graft versus host disease (according to Shulman criteria) * Engraftment defined as a neutrophil count > 0.5 x 109/L with use of granulocyte-colony stimulating factor (G-CSF) within 40 days * Rejection defined as >95% recipient chimerism, or reinfusion of donor cells after successful engraftment * Prospective validation of the pharmacokinetic model * Lymphocyte subset reconstitution monitored throughout the treatment (including some rare populations) for future studies	—

Measure

Time frame

* Survival (overall survival, event free survival, non-relapse mortality, relapse mortality) * Relapse incidence * Incidence of viral reactivations (CMV, Adenovirus, EBV, HHV6, BK-virus) * Acute graft versus host disease (according to Glucksberg criteria) * Chronic graft versus host disease (according to Shulman criteria) * Engraftment defined as a neutrophil count > 0.5 x 109/L with use of granulocyte-colony stimulating factor (G-CSF) within 40 days * Rejection defined as >95% recipient chimerism, or reinfusion of donor cells after successful engraftment * Prospective validation of the pharmacokinetic model * Lymphocyte subset reconstitution monitored throughout the treatment (including some rare populations) for future studies

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)