Clinical trial NCT05078840: PET Adapted Treatment of Patients With Limited Stage DLBCL and no Risk Factors
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma, Non-Hodgkin's, Adult
Keywords: PET
DLBCL
Lead sponsor: Grupo Argentino de Tratamiento de la Leucemia Aguda
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 75
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with recent diagnosis of DLBCL in limited stages without risk factors and no previous history of mliagnant disease.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients \> 17 years old with no upper age limit.
* Histological diagnosis of DLBCL Stages I or II
* Patients who have signed informed consent.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
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.
timeFrame: 36 months
measure: Evaluate OS in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP
timeFrame: 36 months
Secondary outcomes:
measure: Evaluate PFS in patients with negative PET after 3rd cycle who shortened treatment to only 4 cycles of R-CHOP.
timeFrame: 36 months
measure: Evaluate PFS in patients with positive PET after 3rd cycle who continue treatment with R-CHOP x 1 and Radiotherapy.
timeFrame: 36 months
measure: 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
timeFrame: 36 months
measure: 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
timeFrame: 36 months
measure: 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
timeFrame: 36 months
measure: Compare our results in terms of OS and PFS with those described in patients treated with R-CHOP x6
timeFrame: 36 months
measure: 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)
timeFrame: 36 months
measure: 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
timeFrame: 36 months
measure: 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
timeFrame: 36 months
Other outcomes:
Locations:
city: Paraná
country: Argentina
facility: Instituto Privado de Hematologia y Hemoterapia
state: Entre Ríos
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
state: Provincia De Buenos Aires
city: Rosario
country: Argentina
facility: IDHEA Clínica Hematológica
state: Santa Fe
city: Caba
country: Argentina
facility: FUNDALEU
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Córdoba
country: Argentina
facility: Clínica Universitaria Reina Fabiola
city: Córdoba
country: Argentina
facility: Hospital Privado de Córdoba
Study officials:
affiliation: Grupo Argentino de Tratamiento de la Leucemia Aguda
name: Amalia Cerutti, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Grupo Argentino de Tratamiento de la Leucemia Aguda
name: Astrid Pavlovsky, Dr.
role: STUDY_CHAIR
References: