Diffuse Large B Cell LymphomaPhase 2FIL_DLCL10NCT03364439
R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients
A Phase 2 study testing Treatment plan in people with Diffuse Large B Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 19 sites in Italy.
Trial summary
Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 \& consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Treatment plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 19 sitesItaly
- Study dates
- Jan 2012to 18 Mar 2021
- Phase
- Phase 2
- 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
Who may be able to join
- Histological diagnosis of DLBCL (CD20+), follicular lymphoma grade IIIB, T-cell rich large B cell lymphoma
- Age 18-80 years (patients >70 years old: FIT according to VGM evaluation).
- aaIPI=1 +/- bulky and aaIPI=0 with bulky (>7.5 cm)
- ECOG-PS < 3 unless due to lymphoma
- Ventricular ejection fraction ≥ 50%
- Pulmonary, renal and hepatic tests within normal range
Show all 17Show fewer
- Negative HIV and HBV tests. In case of HBcAb positive and HBsAb +/-, which is indicative of a past infection (occult carriers) the subject can be included, but antiviral prophylaxis with lamivudine must be given from the beginning of treatment until 12 months after treatment completion. Anti-HCV positive patients can be included in the absence of viral replication (HVR-RNA absent or less than 500 copies/ml.
- Written informed consent
- Life-expectancy > 3 months
- Main Exclusion Criteria:
- T-cell lymphoma
- Follicular lymphoma (grade I, II, IIIA), marginal zone and mantle lymphoma
- PS> 3 (if not due to lymphoma)
- Age-adjusted IPI = 0 in the absence of bulky disease
- Age> 80 and <18 years (see inclusion criteria)
- HIV positivity
- significant cardiopathy
Who cannot join
None listed.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Italy19 sites
A.O. SS. Antonio e Biagio e C. Arrigo
Alessandria, 15121
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
Ancona, 60126
Centro di riferimento Oncologico Oncologia Medica A
Aviano
Ospedale Degli Infermi - S.C. Oncologia
Biella
A.O. Spedali Civili di Brescia - Ematologia
Brescia
PO Perrino
Brindisi, 72100
Ospedale Businco
Cagliari
Ospedale di Castelfranco Veneto - Ematologia
Castelfranco Veneto
Osp.Generale Di Zona Valduce
Como, 22100
A.O. Niguarda
Milan, MI, 20162
Osp. San Carlo Borromeo Divisione di Oncologia Medica
Milan
A.O. Universitaria Maggiore Della Carita' Di Novara
Novara, 28100
AOU di Parma UO Ematologia e CTMO
Parma
Ausl Di Piacenza
Piacenza, 29121
AO Arcispedale S.Maria Nuova Ematologia
Reggio Emilia
Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture, PZ, 85028
Istituto Clinica Humanitas
Rozzano (MI)
A.O.U. Citta della Salute e della Scienza di Torino - SC Ematologia
Torino, 10126
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino
About this study
Official title: Prospective, Multicentre Phase II Study With R-CHOP- 14 or R-CHOP-21 & Consolidation PET-Oriented Radiotherapy (RT) in Diffuse Large B Cell Lymphoma (DLBCL) Patients With Low Risk Profile According to Age-adjusted IPI (0 With Bulky or 1)
Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 \& consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients
Read the detailed description
Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 \& consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low risk profile according to age-adjusted IPI (0 with bulky or 1)
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Treatment plan
- Keywords
- DLBCL
- 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.
Treatment planDrug
R-CHOP14 or R-CHOP21 for 6 cycles Restaging after 2, 4, 6 cycles Consolidation therapy with RT (36 Gy) if PET positive (PET after 6 R-CHOP cycles)
| Study group | Role | What they receive |
|---|---|---|
| One arm for all patients | Experimental | Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21. Receives: Drug: Treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS Progression Free Survival
defined as non response after 4 or 6 cycles of chemotherapy or progression of disease after consolidation RT or at any time of therapy, relapse or death from any cause.
Measured: 24 months
Secondary outcomes (1)
OS Overall Survival
OS will be defined as the time between the date of initiation of therapy and the date of death from any cause or the date of last follow up
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study startJan 2012
- Primary completionApr 2018
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Giuseppina Cabras, Principal investigator, Ospedale Businco di Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364439
- Sponsor's protocol ID
- FIL_DLCL10
- Acronym
- FIL_DLCL10
- Status last verified
- Feb 2022
- First submitted
- 1 Dec 2017
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre Phase II Study With R-CHOP- 14 or R-CHOP-21 & Consolidation PET-Oriented Radiotherapy (RT) in Diffuse Large B Cell Lymphoma (DLBCL) Patients With Low Risk Profile According to Age-adjusted IPI (0 With Bulky or 1)
- ClinicalTrials.gov ID
- NCT03364439
- Acronym / sponsor ID
- FIL_DLCL10 / FIL_DLCL10
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- DLBCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2018 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 6 Dec 2017 (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.
Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 \& consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients
Detailed description
Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 \& consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low risk profile according to age-adjusted IPI (0 with bulky or 1)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One arm for all patients | Experimental | Drug: Treatment planPatients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histological diagnosis of DLBCL (CD20+), follicular lymphoma grade IIIB, T-cell rich large B cell lymphoma
- Age 18-80 years (patients >70 years old: FIT according to VGM evaluation).
- aaIPI=1 +/- bulky and aaIPI=0 with bulky (>7.5 cm)
- ECOG-PS < 3 unless due to lymphoma
- Ventricular ejection fraction ≥ 50%
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Treatment planR-CHOP14 or R-CHOP21 for 6 cycles Restaging after 2, 4, 6 cycles Consolidation therapy with RT (36 Gy) if PET positive (PET after 6 R-CHOP cycles) | Drug | One arm for all patients |
Primary outcome
PFS Progression Free Survival
Time frame: 24 months
defined as non response after 4 or 6 cycles of chemotherapy or progression of disease after consolidation RT or at any time of therapy, relapse or death from any cause.
1 secondary outcome
OS Overall Survival
Time frame: 48 months
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 3 Mar 2022.
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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 Giuseppina Cabras principal investigator
Ospedale Businco di Cagliari
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment plan in people with Diffuse Large B Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 19 sites 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 17 inclusion and 0 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 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
PFS Progression Free Survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2022.