R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients (FIL_DLCL10)

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)

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

Study Overview

• Status: Completed
• Conditions: Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Drug: Treatment plan

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Alessandria, Italy, 15121
    • A.O. SS. Antonio e Biagio e C. Arrigo
  • Ancona, Italy, 60126
    • A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
  • Aviano, Italy
    • Centro di riferimento Oncologico Oncologia Medica A
  • Biella, Italy
    • Ospedale Degli Infermi - S.C. Oncologia
  • Brescia, Italy
    • A.O. Spedali Civili di Brescia - Ematologia
  • Brindisi, Italy, 72100
    • PO Perrino
  • Cagliari, Italy
    • Ospedale Businco
  • Castelfranco Veneto, Italy
    • Ospedale di Castelfranco Veneto - Ematologia
  • Como, Italy, 22100
    • Osp.Generale Di Zona Valduce
  • Milano, Italy
    • Osp. San Carlo Borromeo Divisione di Oncologia Medica
  • Novara, Italy, 28100
    • A.O. Universitaria Maggiore Della Carita' Di Novara
  • Parma, Italy
    • AOU di Parma UO Ematologia e CTMO
  • Piacenza, Italy, 29121
    • AUSL di Piacenza
  • Reggio Emilia, Italy
    • AO Arcispedale S.Maria Nuova Ematologia
  • Rozzano (MI), Italy
    • Istituto Clinica Humanitas
  • Torino, Italy, 10126
    • 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
  • MI
    • Milano, MI, Italy, 20162
      • A.O. Niguarda
  • PZ
    • Rionero in Vulture, PZ, Italy, 85028
      • Centro di Riferimento Oncologico della Basilicata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One arm for all patients; Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondazione Italiana Linfomi ONLUS
• Investigators: Principal Investigator: Maria Giuseppina Cabras, Ospedale Businco di Cagliari

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): March 18, 2021

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: DLBCL
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: FIL_DLCL10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No