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

Phase 2

Completed

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: Treatment plan

• Registration Number: NCT03364439
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

Brief 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

Detailed 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)

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-06
• Primary Completion: 2018-04
• Study Completion: 2021-03-18
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One arm for all patients	Treatment plan	Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21.

Primary Outcome Measures

Name	Time	Method
PFS Progression Free Survival	24 months	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.

Secondary Outcome Measures

Name	Time	Method
OS Overall Survival	48 months	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

Trial Locations

Locations (19)

A.O. Niguarda; 🇮🇹 Milano, 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

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