Acute Lymphoblastic LeukemiaNCT03803670
Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia, run by University of Rome Tor Vergata.
Trial summary
Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of patients affected by acute lymphoblastic leukemia. The investigators have previously reported that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the presence of leukemic cells in the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- evaluation of cerebrospinal fluid of ALL
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 10 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients affected by ALL underwent to diagnostic lumbar puncture
Who may be able to join
- ALL at onset
- Age >18 years
Who cannot join
- ALL relapsed or refractory
- Age <18 years
About this study
Official title: Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia: A Multicenter, Retrospective Study From The Campus All/Gimema Network
Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of patients affected by acute lymphoblastic leukemia. The investigators have previously reported that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the presence of leukemic cells in the patients'(pts) cerebrospinal fluid (CSF), especially in samples with low cell counts. In the framework of the national Campus ALL program aimed at improving the management of adult ALL patients in the context of the GIMEMA protocols, in the present study the investigators retrospectively evaluated the incidence of occult CNS positivity and its impact on outcome in 241 adult pts with newly diagnosed ALL from 13 centers.
Read the detailed description
Demographic and of laboratory data of 241 adult patients with ALL were retrospectively recorded. All patients underwent diagnostic lumbar puncture and each cerebrospinal fluid sample was examined by CC and FCM. The investigators identified patients with the only FCM positivity and the investigators correlated this condition with clinical and of laboratory data and with clinical outcome.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- evaluation of cerebrospinal fluid of ALL
- Keywords
- acute lymphoblastic leukemia, flow cytometry
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of cerebrospinal fluid of ALLDiagnostic test
We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry
| Study group | Role | What they receive |
|---|---|---|
| acute lymphoblastic leukemia patients | We observed within adult patients with ALL three groups of patients: patients without central nervous system (CNS) involvement, patients with manifest CNS involvement and patients with occult CNS involvement. Receives: Diagnostic Test: evaluation of cerebrospinal fluid of ALL |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of occult CNS disease
relapse rate
Measured: 10 years
impact of occult CNS disease on outcome
overall survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Jan 2007
- Primary completion1 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Ilaria Del Principe, University of Rome Tor Vergata
- Investigators
- Maria Ilaria Del Principe, MD, Principal investigator, University Tor Vergata of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803670
- Sponsor's protocol ID
- RS176/17
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Del Principe MI, Buzzatti E, Piciocchi A, Forghieri F, Bonifacio M, Lessi F, Imbergamo S, Orciuolo E, Rossi G, Fracchiolla N, Trappolini S, Neri B, Sarlo C, Zappasodi P, Dargenio M, Cefalo M, Irno-Consalvo MA, Conti C, Paterno G, De Angelis G, Sciume M, Della Starza I, Venditti A, Foa R, Guarini AR. Clinical significance of occult central nervous system disease in adult acute lymphoblastic leukemia. A multicenter report from the Campus ALL Network. Haematologica. 2021 Jan 1;106(1):39-45. doi: 10.3324/haematol.2019.231704.
PubMed 31879328
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia: A Multicenter, Retrospective Study From The Campus All/Gimema Network
- ClinicalTrials.gov ID
- NCT03803670
- Acronym / sponsor ID
- RS176/17
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- acute lymphoblastic leukemia, flow cytometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Jan 2007
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of patients affected by acute lymphoblastic leukemia. The investigators have previously reported that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the presence of leukemic cells in the patients'(pts) cerebrospinal fluid (CSF), especially in samples with low cell counts. In the framework of the national Campus ALL program aimed at improving the management of adult ALL patients in the context of the GIMEMA protocols, in the present study the investigators retrospectively evaluated the incidence of occult CNS positivity and its impact on outcome in 241 adult pts with newly diagnosed ALL from 13 centers.
Detailed description
Demographic and of laboratory data of 241 adult patients with ALL were retrospectively recorded. All patients underwent diagnostic lumbar puncture and each cerebrospinal fluid sample was examined by CC and FCM. The investigators identified patients with the only FCM positivity and the investigators correlated this condition with clinical and of laboratory data and with clinical outcome.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute lymphoblastic leukemia patients | – | Diagnostic Test: evaluation of cerebrospinal fluid of ALLWe observed within adult patients with ALL three groups of patients: patients without central nervous system (CNS) involvement, patients with manifest CNS involvement and patients with occult CNS involvement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients affected by ALL underwent to diagnostic lumbar puncture
Key inclusion criteria (2 listed)
- ALL at onset
- Age >18 years
Key exclusion criteria (2 listed)
- ALL relapsed or refractory
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of cerebrospinal fluid of ALLWe evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry | Diagnostic test | acute lymphoblastic leukemia patients |
Primary outcome
impact of occult CNS disease
Time frame: 10 years
relapse rate
impact of occult CNS disease on outcome
Time frame: 10 years
overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 31879328Del Principe MI, Buzzatti E, Piciocchi A, Forghieri F, Bonifacio M, Lessi F, Imbergamo S, Orciuolo E, Rossi G, Fracchiolla N, Trappolini S, Neri B, Sarlo C, Zappasodi P, Dargenio M, Cefalo M, Irno-Consalvo MA, Conti C, Paterno G, De Angelis G, Sciume M, Della Starza I, Venditti A, Foa R, Guarini AR. Clinical significance of occult central nervous system disease in adult acute lymphoblastic leukemia. A multicenter report from the Campus ALL Network. Haematologica. 2021 Jan 1;106(1):39-45. doi: 10.3324/haematol.2019.231704.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Ilaria Del Principe, MD principal investigator
University Tor Vergata of Rome
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by University of Rome Tor Vergata.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of occult CNS disease (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.