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. - SCRIPT-AM

Västra Götalands Regionen0 sites230 target enrollmentOctober 17, 2022

Overview

No summary available.

Registry

who.int

Start Date

October 17, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Västra Götalands Regionen

•Inclusion criteria for randomization part of the study
•\- Age \=18 years at time of initial AML, age \= 21 years at transplantation.
•\-All women of childbearing potential who have to have a negative pregnancy test within 2 weeks prior to the start of treatment.
•\- Signed informed consent.
•\- Any relapsed AML after initial treatment according to a defined international AML protocol. (NOPHO\-DBH AML 2012/new protocol), OR AML in first remission with transplant indications and treatment according to national AML protocol (NOPHO\-DBH AML 2012 or new protocol).
•\- In hematological remission, defined as
•o \< 5 % leukemic blasts confirmed by flow cytometry in a bone marrow sample taken \=14 days prior to start of conditioning and
•o no evidence of extramedullary disease, including in CNS and
•o no leukemic blasts in the peripheral blood (verified by flow cytometry in case immature cells are detected in the peripheral blood differential).
•\- Patients must have a related or unrelated donor fulfilling any of the following criteria

•Exclusion criteria for the randomization part of the study
•Patients are excluded from the randomization part of the study if any of the criteria below are present:
•\- Diagnosis of Myelodysplastic syndrome (MDS).
•\- Diagnosis of Juvenile myelomonocytic leukemia (JMML).
•\- History of previous malignancy (AML diagnosed as secondary cancer).
•\- Known diagnosis of Fanconi anemia.
•\- Prior autologous or allogeneic hematopoietic stem cell transplant.
•\- Planned prophylactic DLI or other immunotherapy interventions after HCT that are not included in the upfront protocol,
•\- Planned anti\-leukemic medication after HCT that are not included in the upfront protocol
•\- Known intolerance to any of the chemotherapeutic drugs in the protocol.