PET Adapted Treatment of Patients With Limited Stage DLBCL and no Risk Factors
NCT ID: NCT05078840
Last Updated: 2024-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
75 participants
OBSERVATIONAL
2021-06-01
2025-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Evaluation of first line treatment in patients with stage I and II LBCL
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
Interventions
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Evaluation of first line treatment in patients with stage I and II LBCL
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
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Inclusion Criteria
* Histological diagnosis of DLBCL Stages I or II
* Patients who have signed informed consent.
Exclusion Criteria
* 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
17 Years
ALL
No
Sponsors
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Grupo Argentino de Tratamiento de la Leucemia Aguda
OTHER
Responsible Party
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Principal Investigators
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Amalia Cerutti, Dr.
Role: PRINCIPAL_INVESTIGATOR
Grupo Argentino de Tratamiento de la Leucemia Aguda
Astrid Pavlovsky, Dr.
Role: STUDY_CHAIR
Grupo Argentino de Tratamiento de la Leucemia Aguda
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Lorena Fiad, Dr.
Role: primary
Florencia Negri Aranguren, Dr.
Role: primary
Amalia Cerutti, Dr.
Role: primary
Fernando Warley, Dr.
Role: primary
Luciano Salvano, Dr.
Role: primary
Luciana Guanchiale, Dr.
Role: primary
Other Identifiers
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GATLA 10-LNHDCG-20
Identifier Type: -
Identifier Source: org_study_id
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