An observational study in Acute Lymphoblastic Leukemia, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Observational
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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 11th largest by planned enrollment of the 28 observational ones that give a count, is one of 12 that started in 2022, is one of 28 observational ones, reaches primary completion later than 4 of the 42 other live ones, and was the 140th 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: 18 Years and older · all sexes · no healthy volunteers.
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. 12 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is above 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:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia 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.
Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in adult Ph-neg ALL patients Secondary objectives
Study design The study is prospective and observational, multicenter, real-life study involving 26 centers afferent to the SEIFEM group. All Ph-neg ALL patients aged 18 years or older treated with intensive chemotherapy starting from 01.06.22 for the duration of 18 months (+12 months follow-up) will be enrolled. The diagnosis of IFI will be defined according to EORTC 2019 criteria. Clinical information will be collected in paper CRFs, compiled anonymously.
The incidence of IFI and pulmonary aspergillosis during induction chemotherapy will be related to the following variables:
Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in adult Ph-neg ALL patients Secondary objectives
Study design The study is prospective and observational, multicenter, real-life study involving 26 centers afferent to the SEIFEM group. All Ph-neg ALL patients aged 18 years or older treated with intensive chemotherapy starting from 01.06.22 for the duration of 18 months (+12 months follow-up) will be enrolled. The diagnosis of IFI will be defined according to EORTC 2019 criteria. Clinical information will be collected in paper CRFs, compiled anonymously.
The incidence of IFI and pulmonary aspergillosis during induction chemotherapy will be related to the following variables:
Inclusion criteria
Secondary endpoints
Patients affected by Ph-pos ALL
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.
Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients
Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients
Time frame: 16 weeks
- Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted
- Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted
Time frame: 16 weeks
- Incidence of IFI in patients with Ph-neg ALL during induction in relation to age
- Incidence of IFI in patients with Ph-neg ALL during induction in relation to age
Time frame: 16 weeks
- Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia
- Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia
Time frame: 16 weeks
- Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)
- Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)
Time frame: 16 weeks
- Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI
- Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI
Time frame: 16 weeks
Patient mortality rate in Ph-neg ALL patients with IFI
Patient mortality rate in Ph-neg ALL patients with IFI
Time frame: 16 weeks
Plan to share: No
Ran from Apr 2022 to primary completion in Mar 2024, 22 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 22 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia