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.
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