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Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML

NCT05477589 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2024-12-19

No results posted yet for this study

Summary

It is a randomized phase 3 study comparing two conditioning regimens in children with Acute Myeloid Leukemia, AML, undergoing allogenic stem cell transplantation. The primary aim is to investigate if a conditioning regimen containing one alkylator (Bu) combined with two antimetabolites (Clo and Flu) results in superior 2-year acute grade III to IV-free, chronic non-limited GvHD-free, relapse free survival than a conditioning regimen combining three alkylating agents (BuCyMel)

Conditions

  • Acute Myeloid Leukemia (AML) in Remission
  • Stem Cell Transplantation

Interventions

DRUG

busulfan, cyclophosphamide and melphalan, BuCyMel

a three alkylator combination of busulfan, cyclophosphamide and melphalan (BuCyMel, standard arm)

DRUG

clofarabine, fludarabine and busulfan, CloFluBu

combination of clofarabine, fludarabine and busulfan in which two alkylators are replaced by antimetabolites (CloFluBu, experimental arm)

Sponsors & Collaborators

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Karin Mellgren, Prof. MD · Sahlgrenska University Hospital

  • Birgitta Versluys, MD, Phd · Princess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2029-12-31
Completion
2031-12-31

Countries

  • Belgium
  • Denmark
  • Finland
  • Hong Kong
  • Israel
  • Lithuania
  • Netherlands
  • Norway
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477589 on ClinicalTrials.gov