NL-OMON53923
Not yet recruiting
Phase 3
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 Götaland Regionen0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Acute Myeloid Leukemia (AML)
- Sponsor
- Västra Götaland Regionen
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for randomization part of the study:
- •Age \<\=18 years at time of initial AML, age \<\= 21 years at transplantation.
- •HCT is performed in a study participating center
- •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).
Exclusion Criteria
- •Exclusion criteria for randomization part of the study:
- •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 immunotherapeutic 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.
Outcomes
Primary Outcomes
Not specified
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