Actively Recruiting
Randomized Phase III Trial Comparing CloFluBu and BuCyMel Conditioning Regimens in Children With Acute Myeloid Leukemia Undergoing Allogeneic Stem Cell Transplantation
Led by Vastra Gotaland Region · Updated on 2024-12-19
170
Participants Needed
17
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different chemotherapy preparation plans, called conditioning regimens, for children with Acute Myeloid Leukemia (AML) who are undergoing allogeneic stem cell transplantation. The study aims to determine if a regimen with one alkylator drug plus two antimetabolite drugs results in better 2-year survival without severe graft-versus-host disease (GvHD) or relapse compared to a regimen with three alkylator drugs. This is a phase III, randomized, open-label study conducted at multiple centers. The trial compares two treatment groups: one receiving a three alkylator combination of busulfan, cyclophosphamide, and melphalan (BuCyMel), and the other receiving a combination of clofarabine, fludarabine, and busulfan (CloFluBu) where two alkylators are replaced by antimetabolites. Participants are randomly assigned to one of these conditioning regimens before their stem cell transplant. The study also includes an observational part for patients who are not eligible or do not consent to the randomized part, allowing researchers to register their outcomes. During the study, participants will undergo regular evaluations including survival status, incidence of GvHD, relapse rates, and various blood and immune system tests up to two years after transplantation. Researchers will monitor transplant-related complications, quality of life, and long-term effects on nutrition and hormones. The total follow-up period for measuring these outcomes is two years, with data collected on engraftment success and transplant-related mortality as well.
CONDITIONS
Brief 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 stem cell transplantation performed at a participating study center
- Negative pregnancy test for women of childbearing potential within 2 weeks before treatment
- Signed informed consent
- Diagnosis of relapsed AML after initial treatment per defined protocol, or AML in first remission with transplant indication
- Hematological remission with less than 5% leukemic blasts in bone marrow, no extramedullary disease, and no leukemic blasts in peripheral blood
- Availability 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 or secondary AML
- Known Fanconi anemia
- Prior autologous or allogeneic hematopoietic stem cell transplant
- Planned immunotherapy or anti-leukemic medication post-transplant not included in protocol
- Known intolerance to study chemotherapy drugs
- Major organ failure preventing chemotherapy use
- Uncontrolled infections at enrollment
- Severe concomitant disease preventing protocol treatment
- Karnofsky/Lansky score below 50%
- Pregnancy or breastfeeding
- Unwillingness or inability to comply with study procedures
- Age above 21 years at transplantation for observational part
- No consent to register outcome data for observational part
- Prior hematopoietic stem cell transplant for observational part
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until completion of conditioning regimen prior to transplantation
Participants receive one of two conditioning drug regimens, either BuCyMel or CloFluBu, before undergoing allogeneic stem cell transplantation.
Multiple visits for drug administration and monitoring during conditioning
Duration - Up to 2 years after transplantation
Participants are monitored for transplant outcomes, graft function, survival, graft-versus-host disease, toxicity, and quality of life following transplantation.
Regular follow-up visits up to 2 years post-transplant
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
A
Anna M Schröder Håkansson, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here