Diffuse Large B Cell Lymphoma (DLBCL)REVERSE_2021NCT06822829
Multicenter Retrospective Observational Study of Relapsed Diffuse Large B-Cell Lymphoma Presenting as Indolent Lymphoma
An observational study of Diffuse Large B Cell Lymphoma (DLBCL) and Indolent B-Cell Lymphomas, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
Most relapses of diffuse large B-cell lymphoma (DLBCL) occur as high-grade lymphoma within the first two years after diagnosis. Relapses as indolent lymphoma are rare events, and the true incidence of this phenomenon is unknown, since literature data are scarce/ and usually restricted to case reports. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL), Indolent B-Cell Lymphomas, Indolent B Cell Lymphoma
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 19 Aug 2024to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be proposed to patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who have relapsed as indolent B-cell lymphoma, with a histologically confirmed diagnosis of relapse and availability of the histological report. Patients who are still alive will be contacted and informed by the specialist about the study's objectives and will be required to sign a specific informed consent form. For patients lost to follow-up or deceased, a waiver of informed consent has been obtained from the Ethics Committee in accordance with applicable regulations.
Who may be able to join
- Age 18 years or older at the time of diagnosis.
- Previous diagnosis of diffuse large B-cell lymphoma with/without a discordant component of indolent B-cell lymphoma, or previous diagnosis of diffuse large B-cell lymphoma transformed from indolent B-cell lymphoma.
- First-line treatment for diffuse large B-cell lymphoma.
- Histologically documented relapse of indolent B-cell lymphoma, diagnosed between 2010 and 2020.
- Availability of the histological report of the relapse.
- Availability of clinical and laboratory data related to both the initial diagnosis and relapse.
- Availability of follow-up data.
- Consent to participate in the study and signing of the specific informed consent form (for living and/or contactable patients).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia
Attilio Gennaro, Clinical Research Coordinator, attilio.gennaro@ausl.re.it
Maria Elena Nizzoli, MD
About this study
Most relapses of diffuse large B-cell lymphoma (DLBCL) occur as high-grade lymphoma within the first two years after diagnosis. Relapses as indolent lymphoma are rare events, and the true incidence of this phenomenon is unknown, since literature data are scarce/ and usually restricted to case reports. Analogously, reported treatment strategies are rather heterogeneous, since no standard of care is established and advanced age together with previous anthracycline exposure may narrow the therapeutic choice.
The goal of this observational study is to assess epidemiological, clinical characteristics and survival of diffuse large b-cell lymphoma (DLBCL) relapsing as indolent lymphoma.
More precisely, the study aims at identifying diagnostic and imaging features associated with relapse as indolent lymphoma and at evaluating disease response to selected therapies.
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL), Indolent B-Cell Lymphomas, Indolent B Cell Lymphoma
- Keywords
- indolent relapse, diffuse large b cell lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with diffuse large B-cell lymphoma | Retrospective cohort of patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who relapsed as indolent B-cell lymphoma between 2010 and 2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is calculated from the date of initiation of treatment for indolent lymphoma relapse to death from any cause or the last follow-up for censored cases.
Measured: Up to 2 years
Secondary outcomes (5)
Progression-Free Survival (PFS)
PFS is measured from the date of initiation of treatment for indolent lymphoma relapse until disease progression or death, or the last follow-up for censored cases.
Measured: Up to 2 years
Response Rate
Response to treatment for indolent B-cell lymphoma relapse will be assessed in terms of complete response, partial response, stable disease, and progression, according to the Lugano Classification criteria (Cheson B et al, JCO 2014).
Measured: Up to 2 years
Adverse Events
Long-term adverse events occurring during follow-up (after treatment for indolent lymphoma relapse) will be categorized and graded according to the Common Toxicity Criteria for Adverse Events, referencing the most recent version available.
Measured: Up to 2 years
Type of Therapy
Description of the therapeutic pathway adopted for first-line treatment of diffuse large B-cell lymphoma and second-line treatment for indolent lymphoma relapse.
Measured: Up to 2 years
Cause of Death
Description of the causes of death, with particular focus on death due to disease progression versus other causes.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start19 Aug 2024
- Primary completion17 Oct 2025
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B Cell Lymphoma (DLBCL)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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Maria Elena Nizzoli, MD, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822829
- Sponsor's protocol ID
- 446/2023/OSS/IRCCSRE
- Acronym
- REVERSE_2021
- Status last verified
- May 2026
- First submitted
- 7 Feb 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Link BK, Witzig TE, Maurer MJ, Allmer C, King RL, Feldman AL, Habermann TM, Ansell SM, Slager SL, Cerhan JR, Nowakowski GS. Impact of concurrent indolent lymphoma on the clinical outcome of newly diagnosed diffuse large B-cell lymphoma. Blood. 2019 Oct 17;134(16):1289-1297. doi: 10.1182/blood.2019000858.
PubMed 31350266Ghesquieres H, Berger F, Felman P, Callet-Bauchu E, Bryon PA, Traverse-Glehen A, Thieblemont C, Baseggio L, Michallet AS, Coiffier B, Salles G. Clinicopathologic characteristics and outcome of diffuse large B-cell lymphomas presenting with an associated low-grade component at diagnosis. J Clin Oncol. 2006 Nov 20;24(33):5234-41. doi: 10.1200/JCO.2006.07.5671. Epub 2006 Oct 16.
PubMed 17043351
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Observational Study of Relapsed Diffuse Large B-Cell Lymphoma Presenting as Indolent Lymphoma
- ClinicalTrials.gov ID
- NCT06822829
- Acronym / sponsor ID
- REVERSE_2021 / 446/2023/OSS/IRCCSRE
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL), Indolent B-Cell Lymphomas, Indolent B Cell Lymphoma
- Keywords
- indolent relapse, diffuse large b cell lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 12 Feb 2025 (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.
Most relapses of diffuse large B-cell lymphoma (DLBCL) occur as high-grade lymphoma within the first two years after diagnosis. Relapses as indolent lymphoma are rare events, and the true incidence of this phenomenon is unknown, since literature data are scarce/ and usually restricted to case reports. Analogously, reported treatment strategies are rather heterogeneous, since no standard of care is established and advanced age together with previous anthracycline exposure may narrow the therapeutic choice.
The goal of this observational study is to assess epidemiological, clinical characteristics and survival of diffuse large b-cell lymphoma (DLBCL) relapsing as indolent lymphoma.
More precisely, the study aims at identifying diagnostic and imaging features associated with relapse as indolent lymphoma and at evaluating disease response to selected therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with diffuse large B-cell lymphoma | – | –Retrospective cohort of patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who relapsed as indolent B-cell lymphoma between 2010 and 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be proposed to patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who have relapsed as indolent B-cell lymphoma, with a histologically confirmed diagnosis of relapse and availability of the histological report. Patients who are still alive will be contacted and informed by the specialist about the study's objectives and will be required to sign a specific informed consent form. For patients lost to follow-up or deceased, a waiver of informed consent has been obtained from the Ethics Committee in accordance with applicable regulations.
Key inclusion criteria (8 listed)
- Age 18 years or older at the time of diagnosis.
- Previous diagnosis of diffuse large B-cell lymphoma with/without a discordant component of indolent B-cell lymphoma, or previous diagnosis of diffuse large B-cell lymphoma transformed from indolent B-cell lymphoma.
- First-line treatment for diffuse large B-cell lymphoma.
- Histologically documented relapse of indolent B-cell lymphoma, diagnosed between 2010 and 2020.
- Availability of the histological report of the relapse.
Key exclusion criteria (1 listed)
- None
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
Overall Survival (OS)
Time frame: Up to 2 years
OS is calculated from the date of initiation of treatment for indolent lymphoma relapse to death from any cause or the last follow-up for censored cases.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Response Rate
Time frame: Up to 2 years
Adverse Events
Time frame: Up to 2 years
Type of Therapy
Time frame: Up to 2 years
Cause of Death
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 31350266Wang Y, Link BK, Witzig TE, Maurer MJ, Allmer C, King RL, Feldman AL, Habermann TM, Ansell SM, Slager SL, Cerhan JR, Nowakowski GS. Impact of concurrent indolent lymphoma on the clinical outcome of newly diagnosed diffuse large B-cell lymphoma. Blood. 2019 Oct 17;134(16):1289-1297. doi: 10.1182/blood.2019000858.
- Background: PubMed 17043351Ghesquieres H, Berger F, Felman P, Callet-Bauchu E, Bryon PA, Traverse-Glehen A, Thieblemont C, Baseggio L, Michallet AS, Coiffier B, Salles G. Clinicopathologic characteristics and outcome of diffuse large B-cell lymphomas presenting with an associated low-grade component at diagnosis. J Clin Oncol. 2006 Nov 20;24(33):5234-41. doi: 10.1200/JCO.2006.07.5671. Epub 2006 Oct 16.
- 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.
Maria Elena Nizzoli, MD principal investigator
Azienda USL Reggio Emilia - IRCCS
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 Diffuse Large B Cell Lymphoma (DLBCL) and Indolent B-Cell Lymphomas, run by Azienda USL Reggio Emilia - IRCCS 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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Attilio Gennaro, Clinical Research Coordinator (+39 0522 295175, attilio.gennaro@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 2 years). 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 NCT06822829, which also lists 2 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 5 May 2026.