Actively Recruiting
Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML
Led by Vastra Gotaland Region · Updated on 2024-12-19
170
Participants Needed
17
Research Sites
499 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or younger at initial AML diagnosis, and 21 years or younger at transplantation
- Hematopoietic cell transplantation performed in a study participating center
- Women of childbearing potential must have a negative pregnancy test within 2 weeks before treatment start
- Signed informed consent obtained
- Diagnosis of relapsed AML after initial treatment per defined protocols or AML in first remission with transplant indication
- Hematological remission defined as less than 5% leukemic blasts in bone marrow within 14 days before conditioning, no extramedullary disease, and no leukemic blasts in peripheral blood
- Presence of a related or unrelated donor meeting specific HLA matching criteria
You will not qualify if you...
- Diagnosis of myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML)
- History of previous malignancy where AML is a secondary cancer
- Known diagnosis of Fanconi anemia
- Prior autologous or allogeneic hematopoietic stem cell transplant
- Planned prophylactic donor lymphocyte infusion or immunotherapy not included in the protocol
- Known intolerance to any chemotherapy drugs in the protocol
- Major organ failure preventing planned chemotherapy
- Uncontrolled bacterial, viral, or fungal infections at enrollment
- Severe concomitant diseases such as malformation syndromes, cardiac malformations, metabolic disorders, severe renal, pulmonary, hepatic, or cardiac impairment
- Karnofsky/Lansky performance score less than 50%
- Females who are pregnant or breastfeeding
- Women of childbearing potential or men with partners of childbearing potential unwilling to use effective contraception for one year after transplant
- Inability or unwillingness to comply with study procedures
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Trial Site Locations
Total: 17 locations
1
L'Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Brussels, Belgium, 1020
Not Yet Recruiting
2
Cliniques Universitaires Saint-Luc (CUSL)
Brussels, Belgium, 1200
Not Yet Recruiting
3
Department of Pediatric Hematology, Oncology and SCT, Ghent University Hospital
Ghent, Belgium, 9000
Not Yet Recruiting
4
University Hospital Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
5
Centre Hospitalier Régional de la Citadelle (CHR)/CHU Liège
Liège, Belgium, 4000
Not Yet Recruiting
6
Paediatric Stem Cell Transplant and Immune Deficiency, Department of Pediatric and Adolescent Medicine, Section 4072, Rigshospitalet University Hospital of Copenhagen
Copenhagen, Denmark, DK-2100
Actively Recruiting
7
Division of Hematology, Oncology, and Stem Cell Transplantation, The New Children's Hospital, Helsinki University Hospital
Helsinki, Finland, FIN-00290
Actively Recruiting
8
Department of Pediatrics and Adolescent Medicine, Hong King Children's Hospital
Hong Kong, Hong Kong
Not Yet Recruiting
9
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 4920235
Not Yet Recruiting
10
Vilnius University Hospital Santaros Klinikos Center for Pediatric Oncology and Hematology
Vilnius, Lithuania, 08661
Not Yet Recruiting
11
Princess Máxima Center for Pediatric Oncology
Utrecht, Netherlands, 3584CS
Actively Recruiting
12
Department of Pediatric Hematology and Oncology, Oslo University HospitalOslo University Hospital
Oslo, Norway, 0424
Actively Recruiting
13
Stemcelltransplant unit Hospital Niño Jesús
Madrid, Spain, 28009
Not Yet Recruiting
14
Queen Silvia Children's Hospital, Sahlgrenska University Hospital
Gothenburg, Sweden, 41685
Actively Recruiting
15
Barncancercentrum, avdelning 64, Skane University Hospital
Lund, Sweden, SE- 221 85
Actively Recruiting
16
Pediatric Hematology immunology and stem cell transplantation Astrid Lindgren children's Hospital Huddinge K86-88
Stockholm, Sweden, 141 86
Not Yet Recruiting
17
Childrens department for Blood and tumor diseases Uppsala University Hospital
Uppsala, Sweden, SE-751 85
Not Yet Recruiting
Research Team
K
Karin Mellgren, Prof. MD
CONTACT
A
Anna M Schröder Håkansson, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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