Active (not recruiting) Phase 3 2024-512657-24-00

ALL SCTped 2012 FORUM - Allogeneic Stem Cell Transplantation in Children and Adolescents with Acute Lymphoblastic Leukaemia

Phase 3 – large-scale trial before approval

Conditions: Acute Lymphoblastic Leukaemia

Sponsor: St. Anna Childrens Cancer Research Institute GmbH

trial.available_in:

БГ

Overview

Trial status: Authorised Stratum 1: EFS, Stratum 2: OS, Stratum 1 and 2: Cumulative Incidence of Treatment-related mortality (TRM), Stratum 1 and 2: Cumulative Incidence of Relapse, Stratum 1 and 2: Toxicity: acute and late, Stratum 1 and 2: Acute Graft versus Host Disease (aGVHD) and chronic GVHD (cGvHD), Stratum 1 and 2: Secondary malignancies Stratum 1: Overall Survival (OS), Stratum 2: Event Free Survival (EFS)

Description

Stratum 1: EFS, Stratum 2: OS, Stratum 1 and 2: Cumulative Incidence of Treatment-related mortality (TRM), Stratum 1 and 2: Cumulative Incidence of Relapse, Stratum 1 and 2: Toxicity: acute and late, Stratum 1 and 2: Acute Graft versus Host Disease (aGVHD) and chronic GVHD (cGvHD), Stratum 1 and 2: Secondary malignancies

Who can participate

Age group: 18-64 years, 0-17 years Gender: Female, Male Target enrollment: 1108 participants

Interventions

CYCLOPHOSPHAMIDE

Drug

ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS

Drug

RABBIT ANTI-HUMAN THYMOCYTE IMMUNOGLOBULIN

Drug

THIOTEPA

Drug

FLUDARABINE PHOSPHATE

Drug

TREOSULFAN

Drug

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.

Drug

BUSULFAN

Drug

ETOPOSIDE

Drug

Locations 12

Austria (1)

Belgium (1)

Czech Republic (1)

Denmark (1)

France (1)

Germany (1)

Italy (1)

Netherlands (1)

Norway (1)

Slovakia (1)

Spain (1)

Sweden (1)

Status

Active (not recruiting)

Phase

Phase 3

Study type

INTERVENTIONAL

Sex

Male and female

Minimum age

18 Years

Maximum age

64 Years

Healthy volunteers

Start date

09.10.2024

Registry ID

2024-512657-24-00

Source

euclinicaltrials.eu

trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.