PET Adapted Treatment of Patients With Limited Stage DLBCL and no Risk Factors
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)
1 other identifier
observational
75
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 21, 2021
CompletedFirst Posted
Study publicly available on registry
October 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedJanuary 9, 2024
January 1, 2024
3 years
September 21, 2021
January 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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
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.
36 months
Evaluate PFS in patients with positive PET after 3rd cycle who continue treatment with R-CHOP x 1 and Radiotherapy.
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
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
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
36 months
- +4 more secondary outcomes
Study Arms (1)
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.
Interventions
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
Eligibility Criteria
Adult patients with recent diagnosis of DLBCL in limited stages without risk factors and no previous history of mliagnant disease.
You may qualify if:
- Patients \> 17 years old with no upper age limit.
- Histological diagnosis of DLBCL Stages I or II
- Patients who have signed informed consent.
You may not qualify if:
- 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
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
Instituto Privado de Hematologia y Hemoterapia
Paraná, Entre Ríos Province, Argentina
IDHEA Clínica Hematológica
Rosario, Santa Fe Province, Argentina
FUNDALEU
CABA, Argentina
Hospital Italiano de Buenos Aires
CABA, Argentina
Clínica Universitaria Reina Fabiola
Córdoba, Argentina
Hospital Privado de Córdoba
Córdoba, Argentina
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amalia Cerutti, Dr.
Grupo Argentino de Tratamiento de la Leucemia Aguda
- STUDY CHAIR
Astrid Pavlovsky, Dr.
Grupo Argentino de Tratamiento de la Leucemia Aguda
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2021
First Posted
October 15, 2021
Study Start
June 1, 2021
Primary Completion
June 1, 2024
Study Completion
June 1, 2025
Last Updated
January 9, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will become available on June 2021, and will remain available until the end of the clinical trial.
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