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

ConditionsAcute Myeloid Leukemia (AML) in RemissionStem Cell Transplantation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorVastra Gotaland Region

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 survival than a conditioning regimen combining three alkylating agents (BuCyMel)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • busulfan, cyclophosphamide and melphalan, BuCyMel

    Drug

    a three alkylator combination of busulfan, cyclophosphamide and melphalan (BuCyMel, standard arm)

  • clofarabine, fludarabine and busulfan, CloFluBu

    Drug

    combination of clofarabine, fludarabine and busulfan in which two alkylators are replaced by antimetabolites (CloFluBu, experimental arm)

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: BuCyMelActive comparator 1 intervention
Group B: CloFluBuExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

2-year, acute grade III to IV-free, chronic non-limited GvH-free, relapse-free survival (GREF)

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 survival (GRFS) than a conditioning regimen combining three alkylating agents (BuCyMel)

Time frame
2 years

Secondary outcomes

1

Neutrophil and platelet engraftment

time to engraftment after stem cells transplantation, in all patients

Time frame
28 days post transplantation
2

Primary graft failure

The incidence of graft failure defined as neutrophil recovery by day +28 post transplantation

Time frame
+28 days post transplantation
3

Secondary graft failure

The incidence of secondary graft failure

Time frame
2 years
4

Cumulative incidence of relapse

The incidence of cumulative incidence of relapse during the first two years after transplantation

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Source ClinicalTrials.gov
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