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

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Stem Cell Transplant; Cord Blood; Leukemia

Treatments: Procedure: applying of FLU+CY post-HSCT

Study type: Interventional

Funder types: Other

Identifiers

NCT06155188

NFEC-2022-229

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children acute leukemia

Exclusion criteria

• MODS

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

PT/FLU+CY

Experimental group

Description:

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)

Treatment:

Procedure: applying of FLU+CY post-HSCT