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Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia

ConditionsLeukemiaStem Cell TransplantCord Blood
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorNanfang Hospital, Southern Medical University

About this trial

To determine if the novel regimen of PT/FLU+CY promotes cord blood engraftment in children's leukemia HSCT cohort

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

children acute leukemia

Disqualifiers

MODS

Trial design

Design model

Single group

Treatments tested in this trial

  • applying of FLU+CY post-HSCT

    Procedure/Surgery

    The conditioning regimen (PT-Cy/Flu group) consisted of fludarabine (40mg/m2, d-5 to d-3 and d+3, d+4), busulfan (100mg/m2, d-6 to d-3), haplo-PBSC (d0), PTCy (50mg/kg, d+3, d+4) and UCB (d+6).

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: PT/FLU+CYExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

rate of UCB engraftment

evaluate the regimen if it promotes UCB engraftment

Time frame
initiate STR detection from day+15 thereafter weekly up to 1 year post-HSCT
2

rate of leukemia free survival

determine the leukemia status post-HSCT

Time frame
3 years post-HSCT
3

rate of overall survival

determine the overall survival status post-HSCT

Time frame
3 years post-HSCT

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov
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