Chronic Lymphocytic Leukemia Stage A(0)NCT00917540
Prospective Collection of Biological Data of Prognostic Relevance in Patients With B-Cell Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia Stage A(0) and Chronic Lymphocytic Leukemia Stage A(I), run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
Trial summary
The purpose of the present study is to develop a biological prognostic index in patients with Binet stage A Chronic Lymphocytic Leukemia (CLL) who do not necessitate therapy according to NCI guidelines and to prospectively validate the proposed score system based on the absence/presence of 1, 2 or 3 unfavorable… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia Stage A(0), Chronic Lymphocytic Leukemia Stage A(I), Chronic Lymphocytic Leukemia Stage A(II)
- How many people
- 495 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2007to Apr 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Previously untreated Binet stage A B-CLL patients, who do not necessitate therapy according to NCI guidelines
Who may be able to join
- Established diagnosis of B-CLL by NCI criteria, performed by local haematologist. (Diagnosis will be confirmed by the biological review committee according to flow cytometry analysis (positive clusters of differentiation antigen 5 (CD5), 19 (CD19),23 (CD23)).
- Age > 18 years and < 70 years.
- Eastern Cooperative Oncology Group (ECOG)<=2.
- Binet stage A.
- Diagnosis performed within 12 months before inclusion in the study.
- Patients who do not necessitate therapy by NCI guidelines (watch and wait policy).
Show all 9Show fewer
- Shipment of peripheral blood sample to centralized laboratory for biological assessment.
- Clinical data including baseline information on disease localization and laboratory parameters at staging and assurance of follow up updating for at least 3 years are requested.
- Written informed consent.
Who cannot join
- Patients with CLL whose diagnosis exceed 12 months before registration.
- Patients with leukemic phase of lymphoproliferative disorders of B origin CD5- and/or CD23- according to flow cytometry analysis.
- Clinical Binet stage B or C.
- Patients who necessitate therapy according to NCI guide-lines (no watch and wait policy).
- Age > 70 years.
- Without a written informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
GISL Trial Office
Modena, 41100
Emanuela A Pesce, BSc, +39 059 422 2688, emanuelaanna.pesce@unimore.it
Massimo Federico, MD
About this study
Official title: Prospective Collection of Biological Data of Prognostic Relevance in Patients
The purpose of the present study is to develop a biological prognostic index in patients with Binet stage A Chronic Lymphocytic Leukemia (CLL) who do not necessitate therapy according to NCI guidelines and to prospectively validate the proposed score system based on the absence/presence of 1, 2 or 3 unfavorable prognostic markers such as cluster of differentiation 38 (CD38) expression, Zap-70 expression and immunoglobulin heavy chain variable region (IgVH) configuration.
Read the detailed description
Clinical data including information on disease localization and laboratory parameters will be collected at study entry, during follow up and at disease progression (or after 36 months after registration) Biological markers will be evaluated at centralized laboratory, at study entry and at time of disease progression (or after 24 months of follow-up for non progressed patients) Using the scoring system, patients can be separated into 3 risk groups: low-risk (score 0), intermediate-risk (score 1) and high-risk (score 2-3), with significantly different clinical courses.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective validation of the prognostic potential of a score system based on the presence/absence of three risk factors (VH mutational status, Zap-70 and CD38 expression) on Progression Free Survival (PFS ).
Measured: 6 months
Secondary outcomes (3)
Quality of Life
Measured: 6 months
Time to Treatment
Measured: 6 months
Overall Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startFeb 2007
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic Leukemia Stage A(0)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Studio Linfomi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fortunato Morabito, MD, Study chair, GISLManlio Ferrarini, MD, Study chair, GISL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917540
- Sponsor's protocol ID
- O-CLL1
- Status last verified
- Apr 2013
- First submitted
- 8 May 2009
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Matis S, Grazia Recchia A, Colombo M, Cardillo M, Fabbi M, Todoerti K, Bossio S, Fabris S, Cancila V, Massara R, Reverberi D, Emionite L, Cilli M, Cerruti G, Salvi S, Bet P, Pigozzi S, Fiocca R, Ibatici A, Angelucci E, Gentile M, Monti P, Menichini P, Fronza G, Torricelli F, Ciarrocchi A, Neri A, Fais F, Tripodo C, Morabito F, Ferrarini M, Cutrona G. MiR-146b-5p regulates IL-23 receptor complex expression in chronic lymphocytic leukemia cells. Blood Adv. 2022 Oct 25;6(20):5593-5612. doi: 10.1182/bloodadvances.2021005726.
PubMed 35819446Morabito F, Tripepi G, Vigna E, Bossio S, D'Arrigo G, Martino EA, Storino F, Recchia AG, Fronza G, Di Raimondo F, Colombo M, Fais F, Neri A, Cutrona G, Ferrarini M, Gentile M. Validation of the Alternative International Prognostic Score-E (AIPS-E): Analysis of Binet stage A chronic lymphocytic leukemia patients enrolled into the O-CLL1-GISL protocol. Eur J Haematol. 2021 Jun;106(6):831-835. doi: 10.1111/ejh.13614. Epub 2021 Apr 7.
PubMed 33662164Kreuzberger N, Damen JA, Trivella M, Estcourt LJ, Aldin A, Umlauff L, Vazquez-Montes MD, Wolff R, Moons KG, Monsef I, Foroutan F, Kreuzer KA, Skoetz N. Prognostic models for newly-diagnosed chronic lymphocytic leukaemia in adults: a systematic review and meta-analysis. Cochrane Database Syst Rev. 2020 Jul 31;7(7):CD012022. doi: 10.1002/14651858.CD012022.pub2.
PubMed 32735048Morabito F, Cutrona G, Mosca L, D'Anca M, Matis S, Gentile M, Vigna E, Colombo M, Recchia AG, Bossio S, De Stefano L, Maura F, Manzoni M, Ilariucci F, Consoli U, Vincelli I, Musolino C, Cortelezzi A, Molica S, Ferrarini M, Neri A. Surrogate molecular markers for IGHV mutational status in chronic lymphocytic leukemia for predicting time to first treatment. Leuk Res. 2015 Aug;39(8):840-5. doi: 10.1016/j.leukres.2015.05.005. Epub 2015 May 19.
PubMed 26038121Maura F, Mosca L, Fabris S, Cutrona G, Matis S, Lionetti M, Agnelli L, Barbieri M, D'Anca M, Manzoni M, Colombo M, Massucco C, Reverberi D, Gentile M, Recchia AG, Bossio S, Ilariucci F, Musolino C, Di Raimondo F, Cortelezzi A, Morabito F, Ferrarini M, Neri A. Insulin growth factor 1 receptor expression is associated with NOTCH1 mutation, trisomy 12 and aggressive clinical course in chronic lymphocytic leukaemia. PLoS One. 2015 Mar 18;10(3):e0118801. doi: 10.1371/journal.pone.0118801. eCollection 2015.
PubMed 25786252
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Biological Data of Prognostic Relevance in Patients
- ClinicalTrials.gov ID
- NCT00917540
- Acronym / sponsor ID
- O-CLL1
- Conditions
- Chronic Lymphocytic Leukemia Stage A(0), Chronic Lymphocytic Leukemia Stage A(I), Chronic Lymphocytic Leukemia Stage A(II)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- Gruppo Italiano Studio LinfomiUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Apr 2013 (estimated)
- First posted
- 10 Jun 2009 (estimated)
- 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.
The purpose of the present study is to develop a biological prognostic index in patients with Binet stage A Chronic Lymphocytic Leukemia (CLL) who do not necessitate therapy according to NCI guidelines and to prospectively validate the proposed score system based on the absence/presence of 1, 2 or 3 unfavorable prognostic markers such as cluster of differentiation 38 (CD38) expression, Zap-70 expression and immunoglobulin heavy chain variable region (IgVH) configuration.
Detailed description
Clinical data including information on disease localization and laboratory parameters will be collected at study entry, during follow up and at disease progression (or after 36 months after registration) Biological markers will be evaluated at centralized laboratory, at study entry and at time of disease progression (or after 24 months of follow-up for non progressed patients) Using the scoring system, patients can be separated into 3 risk groups: low-risk (score 0), intermediate-risk (score 1) and high-risk (score 2-3), with significantly different clinical courses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously untreated Binet stage A B-CLL patients, who do not necessitate therapy according to NCI guidelines
Key inclusion criteria (9 listed)
- Established diagnosis of B-CLL by NCI criteria, performed by local haematologist. (Diagnosis will be confirmed by the biological review committee according to flow cytometry analysis (positive clusters of differentiation antigen 5 (CD5), 19 (CD19),23 (CD23)).
- Age > 18 years and < 70 years.
- Eastern Cooperative Oncology Group (ECOG)<=2.
- Binet stage A.
- Diagnosis performed within 12 months before inclusion in the study.
Key exclusion criteria (6 listed)
- Patients with CLL whose diagnosis exceed 12 months before registration.
- Patients with leukemic phase of lymphoproliferative disorders of B origin CD5- and/or CD23- according to flow cytometry analysis.
- Clinical Binet stage B or C.
- Patients who necessitate therapy according to NCI guide-lines (no watch and wait policy).
- Age > 70 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prospective validation of the prognostic potential of a score system based on the presence/absence of three risk factors (VH mutational status, Zap-70 and CD38 expression) on Progression Free Survival (PFS ).
Time frame: 6 months
3 secondary outcomes
Quality of Life
Time frame: 6 months
Time to Treatment
Time frame: 6 months
Overall Survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Derived from this study: PubMed 35819446Matis S, Grazia Recchia A, Colombo M, Cardillo M, Fabbi M, Todoerti K, Bossio S, Fabris S, Cancila V, Massara R, Reverberi D, Emionite L, Cilli M, Cerruti G, Salvi S, Bet P, Pigozzi S, Fiocca R, Ibatici A, Angelucci E, Gentile M, Monti P, Menichini P, Fronza G, Torricelli F, Ciarrocchi A, Neri A, Fais F, Tripodo C, Morabito F, Ferrarini M, Cutrona G. MiR-146b-5p regulates IL-23 receptor complex expression in chronic lymphocytic leukemia cells. Blood Adv. 2022 Oct 25;6(20):5593-5612. doi: 10.1182/bloodadvances.2021005726.
- Derived from this study: PubMed 33662164Morabito F, Tripepi G, Vigna E, Bossio S, D'Arrigo G, Martino EA, Storino F, Recchia AG, Fronza G, Di Raimondo F, Colombo M, Fais F, Neri A, Cutrona G, Ferrarini M, Gentile M. Validation of the Alternative International Prognostic Score-E (AIPS-E): Analysis of Binet stage A chronic lymphocytic leukemia patients enrolled into the O-CLL1-GISL protocol. Eur J Haematol. 2021 Jun;106(6):831-835. doi: 10.1111/ejh.13614. Epub 2021 Apr 7.
- Derived from this study: PubMed 32735048Kreuzberger N, Damen JA, Trivella M, Estcourt LJ, Aldin A, Umlauff L, Vazquez-Montes MD, Wolff R, Moons KG, Monsef I, Foroutan F, Kreuzer KA, Skoetz N. Prognostic models for newly-diagnosed chronic lymphocytic leukaemia in adults: a systematic review and meta-analysis. Cochrane Database Syst Rev. 2020 Jul 31;7(7):CD012022. doi: 10.1002/14651858.CD012022.pub2.
- Derived from this study: PubMed 26038121Morabito F, Cutrona G, Mosca L, D'Anca M, Matis S, Gentile M, Vigna E, Colombo M, Recchia AG, Bossio S, De Stefano L, Maura F, Manzoni M, Ilariucci F, Consoli U, Vincelli I, Musolino C, Cortelezzi A, Molica S, Ferrarini M, Neri A. Surrogate molecular markers for IGHV mutational status in chronic lymphocytic leukemia for predicting time to first treatment. Leuk Res. 2015 Aug;39(8):840-5. doi: 10.1016/j.leukres.2015.05.005. Epub 2015 May 19.
- Derived from this study: PubMed 25786252Maura F, Mosca L, Fabris S, Cutrona G, Matis S, Lionetti M, Agnelli L, Barbieri M, D'Anca M, Manzoni M, Colombo M, Massucco C, Reverberi D, Gentile M, Recchia AG, Bossio S, Ilariucci F, Musolino C, Di Raimondo F, Cortelezzi A, Morabito F, Ferrarini M, Neri A. Insulin growth factor 1 receptor expression is associated with NOTCH1 mutation, trisomy 12 and aggressive clinical course in chronic lymphocytic leukaemia. PLoS One. 2015 Mar 18;10(3):e0118801. doi: 10.1371/journal.pone.0118801. eCollection 2015.
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.
Fortunato Morabito, MD study chair
GISL
Manlio Ferrarini, MD study chair
GISL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia Stage A(0) and Chronic Lymphocytic Leukemia Stage A(I), run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fortunato Morabito, MD (+39 0984 681329, fortunato_morabito@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective validation of the prognostic potential of a score system based on the presence/absence of three risk factors (VH mutational status, Zap-70 and CD38 expression) on Progression Free Survival (PFS ). (time frame: 6 months). 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 NCT00917540, which also lists 5 linked publications.
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 9 Apr 2013.