RecruitingPhase 3NCT05477589

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

A Randomized, Multi-Center Phase III Trial Comparing Two Conditioning Regimens (CloFluBu and BuCyMel) in Children With Acute Myeloid Leukemia Undergoing Allogeneic Stem Cell Transplantation.

Sponsor

Vastra Gotaland Region

Enrollment

170 participants

Start Date

Jun 7, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia (AML) in Remission Stem Cell Transplantation

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)

Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different pre-transplant treatment regimens (called conditioning regimens) for children and young adults with Acute Myeloid Leukemia (AML — a fast-growing blood cancer) who need a stem cell transplant. It aims to find out which approach is safer and more effective. **You may be eligible if...** - You are 18 years old or younger at initial AML diagnosis, and no older than 21 at the time of transplant - You have relapsed AML or AML in first remission with an indication for transplant - Your cancer is in remission (fewer than 5% leukemia cells in bone marrow) - A suitable bone marrow or stem cell donor is available - You have had no recent pregnancy (for women of childbearing potential) **You may NOT be eligible if...** - Your disease is not in remission at the time of transplant - No suitable donor is available - You do not meet the specific disease or treatment history requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGbusulfan, cyclophosphamide and melphalan, BuCyMel

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

DRUGclofarabine, fludarabine and busulfan, CloFluBu

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

Locations(17)

L'Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

Brussels, Belgium

Cliniques Universitaires Saint-Luc (CUSL)

Brussels, Belgium

Department of Pediatric Hematology, Oncology and SCT, Ghent University Hospital

Ghent, Belgium

University Hospital Leuven

Leuven, Belgium

Centre Hospitalier Régional de la Citadelle (CHR)/CHU Liège

Liège, Belgium

Paediatric Stem Cell Transplant and Immune Deficiency, Department of Pediatric and Adolescent Medicine, Section 4072, Rigshospitalet University Hospital of Copenhagen

Copenhagen, Denmark

Division of Hematology, Oncology, and Stem Cell Transplantation, The New Children's Hospital, Helsinki University Hospital

Helsinki, Finland

Department of Pediatrics and Adolescent Medicine, Hong King Children's Hospital

Hong Kong, Hong Kong

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Vilnius University Hospital Santaros Klinikos Center for Pediatric Oncology and Hematology

Vilnius, Lithuania

Princess Máxima Center for Pediatric Oncology

Utrecht, Netherlands

Department of Pediatric Hematology and Oncology, Oslo University HospitalOslo University Hospital

Oslo, Norway

Stemcelltransplant unit Hospital Niño Jesús

Madrid, Spain

Queen Silvia Children's Hospital, Sahlgrenska University Hospital

Gothenburg, Sweden

Barncancercentrum, avdelning 64, Skane University Hospital

Lund, Sweden

Pediatric Hematology immunology and stem cell transplantation Astrid Lindgren children's Hospital Huddinge K86-88

Stockholm, Sweden

Childrens department for Blood and tumor diseases Uppsala University Hospital

Uppsala, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05477589

Related Trials

Phase IB/II of CPX-351 for Relapse Prevention in AML

NCT049901023 locations

A Clinical Study of Ultra-transplantation for the Treatment of Major Thalassemia Scheme

NCT067434771 location

Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients

NCT043142191 location

Fertility Protection for Children, Adolescents and Young Adults

NCT066928681 location

AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

NCT054049062 locations