R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients
NCT ID: NCT03364439
Last Updated: 2022-03-03
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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COMPLETED
PHASE2
109 participants
INTERVENTIONAL
2012-01-31
2021-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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One arm for all patients
Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21.
Treatment plan
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)
Interventions
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Treatment plan
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* HIV positivity
* significant cardiopathy
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Maria Giuseppina Cabras
Role: PRINCIPAL_INVESTIGATOR
Ospedale Businco di Cagliari
Locations
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A.O. Niguarda
Milan, MI, Italy
Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture, PZ, Italy
A.O. SS. Antonio e Biagio e C. Arrigo
Alessandria, , Italy
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
Ancona, , Italy
Centro di riferimento Oncologico Oncologia Medica A
Aviano, , Italy
Ospedale Degli Infermi - S.C. Oncologia
Biella, , Italy
A.O. Spedali Civili di Brescia - Ematologia
Brescia, , Italy
PO Perrino
Brindisi, , Italy
Ospedale Businco
Cagliari, , Italy
Ospedale di Castelfranco Veneto - Ematologia
Castelfranco Veneto, , Italy
Osp.Generale Di Zona Valduce
Como, , Italy
Osp. San Carlo Borromeo Divisione di Oncologia Medica
Milan, , Italy
A.O. Universitaria Maggiore Della Carita' Di Novara
Novara, , Italy
AOU di Parma UO Ematologia e CTMO
Parma, , Italy
Ausl Di Piacenza
Piacenza, , Italy
AO Arcispedale S.Maria Nuova Ematologia
Reggio Emilia, , Italy
Istituto Clinica Humanitas
Rozzano (MI), , Italy
A.O.U. Citta della Salute e della Scienza di Torino - SC Ematologia
Torino, , Italy
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, , Italy
Countries
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Other Identifiers
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FIL_DLCL10
Identifier Type: -
Identifier Source: org_study_id
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