R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients

Diffuse Large B Cell Lymphoma Clinical Trial

— FIL_DLCL10  

Official title:

Prospective, Multicentre Phase II Study With R-CHOP- 14 or R-CHOP-21 & Consolidation PET-Oriented Radiotherapy (RT) in Diffuse Large B Cell Lymphoma (DLBCL) Patients With Low Risk Profile According to Age-adjusted IPI (0 With Bulky or 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364439
• Other study ID #: FIL_DLCL10
• Status: Completed
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: March 18, 2021

Study information

• Verified date: February 2022
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 & consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients

Description:

Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 & consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low risk profile according to age-adjusted IPI (0 with bulky or 1)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 18, 2021
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histological diagnosis of DLBCL (CD20+), follicular lymphoma grade IIIB, T-cell rich large B cell lymphoma

• 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

Main Exclusion Criteria:

• T-cell lymphoma

• 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

• Age> 80 and <18 years (see inclusion criteria)

• HIV positivity

• significant cardiopathy

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
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	A.O. Niguarda	Milano	MI
Italy	Osp. San Carlo Borromeo Divisione di Oncologia Medica	Milano
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	Centro di Riferimento Oncologico della Basilicata	Rionero in Vulture	PZ
Italy	Istituto Clinica Humanitas	Rozzano (MI)
Italy	A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria	Torino
Italy	A.O.U. Citta della Salute e della Scienza di Torino - SC Ematologia	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS Progression Free Survival	defined as non response after 4 or 6 cycles of chemotherapy or progression of disease after consolidation RT or at any time of therapy, relapse or death from any cause.	24 months
Secondary	OS Overall Survival	OS will be defined as the time between the date of initiation of therapy and the date of death from any cause or the date of last follow up	48 months