An observational study in Childhood Acute Lymphoblastic Leukemia, sponsored by IRCCS SYNLAB SDN. Recruiting at 1 site in Italy. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-25.
Sponsored by IRCCS SYNLAB SDN · Observational
Among 148 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in Italy — 29 open to participants now, 43 under way, 10 of them phase 3. Precursor Cell Lymphoblastic Leukemia-Lymphoma · Italy.
Among the 148 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in Italy, this one is the 18th largest by planned enrollment of the 28 observational ones that give a count, is one of 7 that started in 2020, is one of 28 observational ones, reaches primary completion later than 3 of the 42 other live ones, and was the 126th registered.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →29 of the 148 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in Italy are open now. Recruiting first, the newest first:
AstraZeneca · Sites in Italy, United States, Australia and 6 more countries
Ages 16+
Bambino Gesù Hospital and Research Institute · Sites in Italy, Austria, Czechia and 6 more countries
Ages 3 mo–25 yrs
Princess Maxima Center for Pediatric Oncology · Sites in Italy, Austria, Belgium and 11 more countries
Ages 1–21
Princess Maxima Center for Pediatric Oncology · Sites in Italy, Austria, Belgium and 11 more countries
Ages 1–21
University Of Perugia · Sites in Italy
Ages 18–65
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 370 Precursor Cell Lymphoblastic Leukemia-Lymphoma studies recruiting now, 96 (26%) set no upper age limit and 257 (69%) stop at 75 or younger; 247 take children under 18; 29 take healthy volunteers.
This study: 1 Year to 18 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
148 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 37 · Phase 2 79 · Phase 3 30 · Phase 4 3
First in 1994; this study’s year is marked. 7 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is below the median of 108 across 400 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Median enrollment 98 across the 118 interventional studies, 100 across the 28 observational. Of the 86 that completed or were terminated, 40 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
57 of 148 have an industry lead sponsor. The 10 most frequent:
IRCCS SYNLAB SDN is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
IRCCS SYNLAB SDN has 2 studies filed under Precursor Cell Lymphoblastic Leukemia-Lymphoma — fewer than ten, so there is no comparison to draw.
10 of the studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in Italy that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04722848Phase 3Gruppo Italiano Malattie EMatologiche dell'AdultoSequential Treatment With Ponatinib and Blinatumomab vs Chemotherapy and Imatinib in Newly Diagnosed Adult Ph+ ALL | 2027-09 |
| NCT05327894Phase 3Princess Maxima Center for Pediatric OncologyInterfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia | 2027-09 |
| NCT04232241Universitätsklinikum Hamburg-EppendorfMatched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia | 2026-11-22 |
| NCT05366569Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBio-CAR-T BS Study | 2026-12-31 |
| NCT05397496Novartis PharmaceuticalsStudy of PIT565 in Relapsed and/or Refractory B-cell Malignancies | 2027-01-04 |
Add all 10 to your calendar (.ics) → With an account.
Among the 148 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A transcriptomic analysis of bone marrow from B-ALL patients was performed by our research group for identifying novel protein/factor with a putative role of disease biomarker. Along with some already known B-ALL biomarkers, our analysis highlighted deregulation of some members of an emerging protein class denoted as KCTD (Potassium ChannelTetramerization Domain-containing proteins). Starting from our preliminary observations, and considering that KCTDs havenever been studied in ALL, we decided to study these proteins in B- and T-ALL affected pediatric patients, enrolled by our research group in collaboration with AORN Santobono-Pausilipon pediatric oncological hospital.Indeed, the present research program aims at opening a new scenario for the study of KCTD proteins in childhood leukemias. The final goal of the project will be to evaluate the translational relevance of selected deregulated KCTDs as novel biomarkers useful for B-ALL and T-ALL diagnostics, and patient management.
The study foresees the possibility of recruiting approximately 60 patients with B-ALL and 15-20 patients with T-ALL. Furthermore, control subjects with age and sex comparable to those of the patients will be recruited. Finally, about 100 units of cord blood that do not meet the criteria for therapeutic cryopreservation and for which consent has been given for their use for scientific research will be used
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
pediatric patients of 1-16 years old affected by acute lymphoblastic leukemia
Other: observational study
cord blood from healthy donors that cannot be used for clinical purposes
Other: observational study
analysis of biomarkers of interest (DNA-RNA and proteins) in MNC purified from the subjects' blood
KCTD expression levels, by RNAseq approach, in a cohort of B and T cell ALL affected patients compared to unaffected controls
We enroll during this project about 15-20 B-ALL, and 3-6 T-ALL patients.RNAseq experiments for transcriptome analysis will be performed on a study cohort of at least 8 B-ALL patients, 3-4 T-ALL patients, and naive B or T cells purified from cord blood as control for B- and T-ALL correspondingly. Raw counts will be used and an empirical Bayes approach applied (DESeq2, R package). The results will include, for each gene, log-fold change (log2), base mean, p-value and adjusted p-values (Benjamimi-Hochberg). DEgenes output will be exported into format suitable for IPA Ingenuity pathway AnalysisSoftware (Qiagen), for gene annotations, functional analysis and biomarker prediction. The KCTD proteins that will be dereguleted in B-ALL and T-ALL will be studied in detail.
Time frame: 1-12 months
RT-PCR validation of deregulated KCTDs and identification of possible KCTDs interactors in leukemia by functional proteomic approach
After the interpretation of transcriptome data we will perform specific validation experiments by reat-time pcr, westernblotting, flow cytometry and microscopy. Briefly,total RNA will be purified from about 5e6 total MNC and used for RT-PCR experiments; BM smear will be collected for immunofluorescence analysis of deregulated KCTDs; protein total extract will be obtained from at least 1 e 6 total MNC and stored at -80°C until Western Blotting; finally, live mononuclear cells will be treted for permeabilization and cytoplasmic immunostaining of the KCTDs of interest. All experiments will be settled-up on B- and T-ALL in vitro human model systems and then performed on patients and controls cells. Moreover, in order to identify possible interactors of KCTDs proteins we will use B-ALL and T-ALL cell lines for functional proteomics analysis.
Time frame: 13-24 months
Correlation of B-ALL patients clinical data with KCTDs expression level
Firstly, we will evaluated the usefulness of the deregulated KCTD proteins as novel markers of leukemia to be tested by multiparametric clinical flowcytometry. A specific protocol has been already setted-up by our research team, and it is able to stain cytoplasmicantigens (such as KCTD proteins) with surface antigens commonly used for to study hematoogical compartments by flowcytometry. This approach will be useful especially in monitoring patient response to treatment as well as detection of minimal residual disease. Moreover, being able to detect cytoplasmic KCTDs in combination with surface antigens, we planned to describe the KCTDs expression levels in multiple cellular population residing in marrow and peripheral blood.Secondly, the overall data obtained in this study will be also interpreted looking at the patient clinics with particular reference to the response to therapy, the risk of relapse and, when possible, resistance to therapy.
Time frame: 25-36 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2020 to primary completion in Feb 2024, 46 months.
Of 145 non-industry observational studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 143. This study's 46 months is below that.
Counting every sponsor, half of 163 studies reached it within 54 months; a quarter within 24 and three quarters within 142.
How these figures are worked out, and which studies are left out of them.
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Precursor Cell Lymphoblastic Leukemia-Lymphoma →
IRCCS SYNLAB SDN