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

Recruiting Phase 3 Interventional Study
Acute Myeloid Leukemia (AML) in Remission Stem Cell Transplantation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
Up to 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
Vastra Gotaland Region · Government
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About This Trial
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 …
Trial Locations
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Eligibility 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…
Contacts

Karin Mellgren, Prof. MD

+46 (0)31 3421000

karin.mellgren@vgregion.se

CONTACT

Anna M Schröder Håkansson, RN

+46 (0) 761141327

anna.schroder_hakansson@vgregion.se

CONTACT