Lymphoma, Non-Hodgkin's, AdultNCT05078840
PET Adapted Treatment of Patients With Limited Stage DLBCL and no Risk Factors
An observational study of Lymphoma, Non-Hodgkin's, Adult, run by Grupo Argentino de Tratamiento de la Leucemia Aguda at 7 sites in Argentina.
Trial summary
Prospective, multicenter, phase IV study, of real-life evidence destined to evaluate the feasibility and efficacy of performing a treatment adapted to PET-CT in patients with stage I and II DLBCL, without poor prognostic factors. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin's, Adult
- What is being tested?
- Evaluation of first line treatment in patients with stage I and II LBCL
- How many people
- 75 participants
- Where
- 7 sitesArgentina
- Study dates
- 1 Jun 2021to 1 Jun 2025
- How long will I take part?
- 36 Months
- 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 17 years and older
- All sexes
- Child, Adult, Older adult
Study population: Adult patients with recent diagnosis of DLBCL in limited stages without risk factors and no previous history of mliagnant disease.
Who may be able to join
- Patients > 17 years old with no upper age limit.
- Histological diagnosis of DLBCL Stages I or II
- Patients who have signed informed consent.
Who cannot join
- Patients with elevated LDH (lactate dehydrogenase)
- ECOG (Eastern Cooperative Oncology Group) > 2
- Stage III or IV
- Bulky mass (> 7.5 cm)
- Central nervous system involvement
- Testicular lymphoma
Show all 19Show fewer
- Breast involvement
- Eyeball involvement
- Primary mediastinal lymphoma
- Cutaneous primary lymphoma
- Diffuse large B-cell lymphoma of the leg
- HIV positive patients
- Platelet count <100,000 / mcl and total leukocyte count <3,000 / mcl
- Marked impairment of ventricular function (FEy <50%)
- Moderate / severe renal impairment defined by Cl. Cr. <50 ml / min
- Severe liver disease: prothrombin rate <50% and / or bile level. total> 2.5 times normal value
- Pregnant and breastfeeding
- Previous or concomitant diagnosis of indolent lymphoma
- Patients who have previously received chemotherapy and / or radiotherapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Argentina7 sites, 7 recruiting
- Recruiting
FUNDALEU
CABA
Astrid Pavlovsky, Dr., astridp@intramed.net
- Recruiting
Hospital Italiano de Buenos Aires
CABA
Fernando Warley, Dr.
- Recruiting
Clínica Universitaria Reina Fabiola
Córdoba
Luciano Salvano, Dr.
- Recruiting
Hospital Privado de Córdoba
Córdoba
Luciana Guanchiale, Dr.
- Recruiting
Hospital Italiano de La Plata
La Plata, Buenos Aires
Lorena Fiad, Dr.
- Recruiting
Instituto Privado de Hematologia y Hemoterapia
Paraná, Entre Ríos Province
Florencia Negri Aranguren, Dr.
- Recruiting
IDHEA Clínica Hematológica
Rosario, Santa Fe Province
Amalia Cerutti, Dr.
About this study
Official title: Treatment of Patients With Diffuse Large B-cell Non-Hodgkins Lymphoma in Stages I and II Without Risk Factors, Adapted to the Response Evaluated With PET CT (Positron Emission Computed Tomography)
Prospective, multicenter, phase IV study, of real-life evidence destined to evaluate the feasibility and efficacy of performing a treatment adapted to PET-CT in patients with stage I and II DLBCL, without poor prognostic factors.
Read the detailed description
Patients older than 17 years of age, with no upper age limit with a de novo histological diagnosis of DLBCL, in stages I and II and without risk factors, will be included. All patients will have a baseline PET-CT and will undergo 3 cycles of R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). A PET-CT will be performed on day 15-18 of the third cycle that will be centrally reviewed. Those patients with negative PET-CT (Deauville 1, 2 and 3) will receive an additional cycle of R-CHOP and will finish treatment. Patients who have PET-CT with a Deauville 4 score will complete a fourth cycle and then receive radiation therapy to the compromised site. Those patients with a Deauville score of 5 should receive rescue therapy, so they will be outside the protocol.
A standardized follow-up of the patients included with tomographic controls will be carried out, evaluating OS (overall survival) and PFS (progression-free survival) at 3 years as the main objectives.
- Conditions
- Lymphoma, Non-Hodgkin's, Adult
- Being tested
- Evaluation of first line treatment in patients with stage I and II LBCL
- Keywords
- PET, DLBCL
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of first line treatment in patients with stage I and II LBCLOther
Evaluation of first line treatment in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP
| Study group | Role | What they receive |
|---|---|---|
| Patients with DLBCL limited stages and without risk factors | Patients with DLBCL in limited stages and without risk factors that will receive standard chemoimmunotherapy and their treatment will be adapted according to PET response after 3 cycles. Receives: Other: Evaluation of first line treatment in patients with stage I and II LBCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate PFS in patients with stage I and II LBCL (large B cell lymphoma), without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP.
Measured: 36 months
Evaluate OS in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP
Measured: 36 months
Secondary outcomes (9)
Evaluate PFS in patients with negative PET after 3rd cycle who shortened treatment to only 4 cycles of R-CHOP.
Measured: 36 months
Evaluate PFS in patients with positive PET after 3rd cycle who continue treatment with R-CHOP x 1 and Radiotherapy.
Measured: 36 months
Evaluate the prognostic value of baseline MTV (metabolic tumor volume) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP
Measured: 36 months
Evaluate the prognostic value of baseline TLG (total lesion glycolysis) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP
Measured: 36 months
Evaluate the prognostic value of Δ SUV (standardized uptake value) max in interim PET in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP
Measured: 36 months
Compare our results in terms of OS and PFS with those described in patients treated with R-CHOP x6
Measured: 36 months
Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi (interim PET) with R-CHOP x 4 (4 cycles of CHOP)
Measured: 36 months
Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx4+ 2 Rituximab or R-CHOPx 4 + ISRT (involved site radiation therapy) + Zevalin
Measured: 36 months
Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx 4 + RTCC + Zevalin
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-Hodgkin's, AdultStudies 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
- 75 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Grupo Argentino de Tratamiento de la Leucemia Aguda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amalia Cerutti, Dr., Principal investigator, Grupo Argentino de Tratamiento de la Leucemia AgudaAstrid Pavlovsky, Dr., Study chair, Grupo Argentino de Tratamiento de la Leucemia Aguda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078840
- Sponsor's protocol ID
- GATLA 10-LNHDCG-20
- Status last verified
- Jan 2024
- First submitted
- 21 Sep 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share study protocol
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Diffuse Large B-cell Non-Hodgkins Lymphoma in Stages I and II Without Risk Factors, Adapted to the Response Evaluated With PET CT (Positron Emission Computed Tomography)
- ClinicalTrials.gov ID
- NCT05078840
- Acronym / sponsor ID
- GATLA 10-LNHDCG-20
- Conditions
- Lymphoma, Non-Hodgkin's, Adult
- Keywords
- PET, DLBCL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Grupo Argentino de Tratamiento de la Leucemia AgudaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 15 Oct 2021 (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, multicenter, phase IV study, of real-life evidence destined to evaluate the feasibility and efficacy of performing a treatment adapted to PET-CT in patients with stage I and II DLBCL, without poor prognostic factors.
Detailed description
Patients older than 17 years of age, with no upper age limit with a de novo histological diagnosis of DLBCL, in stages I and II and without risk factors, will be included. All patients will have a baseline PET-CT and will undergo 3 cycles of R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). A PET-CT will be performed on day 15-18 of the third cycle that will be centrally reviewed. Those patients with negative PET-CT (Deauville 1, 2 and 3) will receive an additional cycle of R-CHOP and will finish treatment. Patients who have PET-CT with a Deauville 4 score will complete a fourth cycle and then receive radiation therapy to the compromised site. Those patients with a Deauville score of 5 should receive rescue therapy, so they will be outside the protocol.
A standardized follow-up of the patients included with tomographic controls will be carried out, evaluating OS (overall survival) and PFS (progression-free survival) at 3 years as the main objectives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with DLBCL limited stages and without risk factors | – | Other: Evaluation of first line treatment in patients with stage I and II LBCLPatients with DLBCL in limited stages and without risk factors that will receive standard chemoimmunotherapy and their treatment will be adapted according to PET response after 3 cycles. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with recent diagnosis of DLBCL in limited stages without risk factors and no previous history of mliagnant disease.
Key inclusion criteria (3 listed)
- Patients > 17 years old with no upper age limit.
- Histological diagnosis of DLBCL Stages I or II
- Patients who have signed informed consent.
Key exclusion criteria (19 listed)
- Patients with elevated LDH (lactate dehydrogenase)
- ECOG (Eastern Cooperative Oncology Group) > 2
- Stage III or IV
- Bulky mass (> 7.5 cm)
- Central nervous system involvement
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 first line treatment in patients with stage I and II LBCLEvaluation of first line treatment in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP | Other | Patients with DLBCL limited stages and without risk factors |
Primary outcome
Evaluate PFS in patients with stage I and II LBCL (large B cell lymphoma), without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP.
Time frame: 36 months
Evaluate OS in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP
Time frame: 36 months
9 secondary outcomes
Evaluate PFS in patients with negative PET after 3rd cycle who shortened treatment to only 4 cycles of R-CHOP.
Time frame: 36 months
Evaluate PFS in patients with positive PET after 3rd cycle who continue treatment with R-CHOP x 1 and Radiotherapy.
Time frame: 36 months
Evaluate the prognostic value of baseline MTV (metabolic tumor volume) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP
Time frame: 36 months
Evaluate the prognostic value of baseline TLG (total lesion glycolysis) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP
Time frame: 36 months
Evaluate the prognostic value of Δ SUV (standardized uptake value) max in interim PET in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP
Time frame: 36 months
Compare our results in terms of OS and PFS with those described in patients treated with R-CHOP x6
Time frame: 36 months
Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi (interim PET) with R-CHOP x 4 (4 cycles of CHOP)
Time frame: 36 months
Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx4+ 2 Rituximab or R-CHOPx 4 + ISRT (involved site radiation therapy) + Zevalin
Time frame: 36 months
Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx 4 + RTCC + Zevalin
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Yes. Share study protocol
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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.
Amalia Cerutti, Dr. principal investigator
Grupo Argentino de Tratamiento de la Leucemia Aguda
Astrid Pavlovsky, Dr. study chair
Grupo Argentino de Tratamiento de la Leucemia Aguda
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Non-Hodgkin's, Adult, run by Grupo Argentino de Tratamiento de la Leucemia Aguda at 7 sites in Argentina.
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 3 inclusion and 19 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 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Argentina. 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 Astrid Pavlovsky, Dr. (5491150613683, astridp@intramed.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate PFS in patients with stage I and II LBCL (large B cell lymphoma), without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP. (time frame: 36 months). 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?
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 Jan 2024.