Evidence map›Paper›PMID 40547030›Full record

ArticleFrontiers in immunology2025

Phase I/II clinical trial on the safety and preliminary efficacy of donor-derived anti-leukemia cytotoxic T lymphocytes for the prevention of leukemia relapse in children given haploidentical hematopoietic stem cell transplantation: study rational and design.

Daniela Montagna, Patrizia Comoli, Matteo Tanzi, Enrica Montini, Antonia Moretta, Gloria Taurino, Stella Boghen, Arianna Panigari, Tommaso Mina, Giovanna Giorgiani and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06865352 (Phase I/IIa Clinical Trial on the Safety and Preliminary Efficacy of Donor-derived Anti-leukemia Cytotoxic T Lymphocytes for the Prevention of Leukemia Relapse in Children Given Haploidentical Hematopoietic Stem Cell Transplantation), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06865352 phase1 / phase2completednot on this map

Phase I/IIa Clinical Trial on the Safety and Preliminary Efficacy of Donor-derived Anti-leukemia Cytotoxic T Lymphocytes for the Prevention of Leukemia Relapse in Children Given Haploidentical Hematopoietic Stem Cell Transplantation

TypeinterventionalSponsorFondazione IRCCS Policlinico San Matteo di PaviaRan2021 to 2025Enrolled15ConditionsAcute Lymphoblastic Leukemia ALL, Acute Myeloid Leukemia (AML)ArmsHSCT donor leukemia-specific cytotoxic T-cells
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Daniela Montagna *Cell Factory, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Patrizia Comoli *Cell Factory, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Matteo TanziCell Factory, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Enrica MontiniCell Factory, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Antonia MorettaCell Factory, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Gloria TaurinoCell Factory, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Stella BoghenPediatric Hematology/Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Arianna PanigariPediatric Hematology/Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Tommaso MinaPediatric Hematology/Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Giovanna GiorgianiPediatric Hematology/Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Claudia Del FanteImmunohaematology and Transfusion Medicine Service (SIMT), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Cesare PerottiImmunohaematology and Transfusion Medicine Service (SIMT), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Marco ZeccaPediatric Hematology/Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Leuk-CTL-001 (EudraCT n. 2019-003362-41) is a Phase I/II clinical trial on the safety and preliminary efficacy of donor-derived anti-leukemia cytotoxic T lymphocytes (CTLs) for the prevention of leukemia relapse in children given haploidentical hematopoietic stem cell transplantation (HCT). The prognosis for children affected by acute leukemia and transplanted in an advanced disease stage, in the presence of measurable minimal residual disease (MRD) or with unfavorable cytogenetic abnormalities, is still poor and often less than 50%. Adoptive cell therapy based on the infusion of donor-derived CTLs able to recognize patients' leukemia blasts (LB) is a promising approach to control leukemia relapse after allogeneic HCT. We previously described a procedure for Clinical Trial Registration: https://www.isrctn.com/, identifier ISRCTN13301166; https://clinicaltrials.gov/, NCT06865352.

Indexed as

Hematopoietic Stem Cell TransplantationImmunotherapy, AdoptiveLeukemiaT-Lymphocytes, CytotoxicTransplantation, HaploidenticalAdolescentChildChild, PreschoolClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicFemaleGraft vs Host DiseaseHumansInfantMaleRecurrenceadoptive cell therapycytotoxic T lymphocytesgraft-versus-host-diseasehaploidentical hematopoietic stem cell transplantationpediatric acute leukemia

Identifiers

PMID40547030
PMCPMC12178864

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.