NCT07899840|Recruiting
Establishment of a Novel Flow Cytometric Diagnostic Assay to Effectively Evaluate Immune Reconstitution After Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia
Flow HSCT IR f
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Flow HSCT IR f
Sponsor study identifier
observational
150
2 countries
3
Study Start
February 13, 2025
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Objective To assess immune reconstitution during the first 18 months following hematopoietic stem cell transplantation (HSCT) for acute lymphoblastic leukemia (ALL), with a particular focus on the T-cell compartment (thymic regeneration and surrogate markers of cytotoxic function), using a dedicated panel developed within the EuroFlow consortium. Secondary Objectives To assess the impact of donor and recipient characteristics, graft-versus-host disease (GvHD) prophylaxis, and conditioning regimen on post-transplant immune reconstitution. To evaluate the correlation between immune reconstitution and the development of complications using unsupervised analysis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 13, 2025
Actual (reported)October 20, 2026
Actual (reported)October 28, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Flow cytomtetric assessment of post transplant immune reconstitution
Development of a standardized pipeline for longitudinal analysis of identified immune cell subsets.
From enrollment to 18 months post transplant
Flow cytomtetric analysis of post transplant immune reconstitution
From enrollment to 18 months post transplant
RNA sequencing validation
From enrollment to 18 months post transplant
Patients undergoing their first HSCT for ALL
Saint Anna Kinderspital
Vienna, Austria
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, 20900, Italy
Peripheral blood mononuclear cells
First Submitted
October 20, 2026
First Posted
October 28, 2026
Study Start
February 13, 2025
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a Phase I/II Interventional, Open-label Treatment Study Designed to Evaluate the Safety and Efficacy of Anti CD 19/22 CAR- T Cells Immunotherapy for Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma.
Contact the study team to confirm eligibility.
Azienda Ospedaliera Università Padova
Padova, PD, 35128, Italy
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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