Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia
Not Applicable
Recruiting
- Conditions
- Stem Cell TransplantCord BloodLeukemia
- Interventions
- Procedure: applying of FLU+CY post-HSCT
- Registration Number
- NCT06155188
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
To determine if the novel regimen of PT/FLU+CY promotes cord blood engraftment in children's leukemia HSCT cohort
- Detailed Description
PTCy is a well-established haploidentical transplant regimen strategy. Moreover, unrelated cord blood (UCB) plays a critical role in the effects of GVL. However, the engraftment of grafts is unpredictable in the setting of a haplo-cord subsequent transplant. Therefore, applying a novel post-transplant regimen of PT/CY+FLU may selectively promote UCB engraftment in the setting of haplo-cord transplant.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- children acute leukemia
Exclusion Criteria
- MODS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PT/FLU+CY applying of FLU+CY post-HSCT The group consisted of fludarabine (40mg/m2, day-5 to day-3 and day+3, day+4), busulfan (100mg/m2, day-6 to day-3), haplo-PBSC (day0), cyclophosphamide (50mg/kg, day+3, day+4) , and UCB (day+6)
- Primary Outcome Measures
Name Time Method rate of UCB engraftment initiate STR detection from day+15 thereafter weekly up to 1 year post-HSCT evaluate the regimen if it promotes UCB engraftment
rate of leukemia free survival 3 years post-HSCT determine the leukemia status post-HSCT
rate of overall survival 3 years post-HSCT determine the overall survival status post-HSCT
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China