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

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Treatment plan
Sponsored by
Fondazione Italiana Linfomi - ETS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring DLBCL

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.O. Niguarda
  • Centro di Riferimento Oncologico della Basilicata
  • A.O. SS. Antonio e Biagio e C. Arrigo
  • A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
  • Centro di riferimento Oncologico Oncologia Medica A
  • Ospedale Degli Infermi - S.C. Oncologia
  • A.O. Spedali Civili di Brescia - Ematologia
  • PO Perrino
  • Ospedale Businco
  • Ospedale di Castelfranco Veneto - Ematologia
  • Osp.Generale Di Zona Valduce
  • Osp. San Carlo Borromeo Divisione di Oncologia Medica
  • A.O. Universitaria Maggiore Della Carita' Di Novara
  • AOU di Parma UO Ematologia e CTMO
  • Ausl Di Piacenza
  • AO Arcispedale S.Maria Nuova Ematologia
  • Istituto Clinica Humanitas
  • A.O.U. Citta della Salute e della Scienza di Torino - SC Ematologia
  • A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One arm for all patients

Arm Description

Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2017
Last Updated
February 15, 2022
Sponsor
Fondazione Italiana Linfomi - ETS
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1. Study Identification

Unique Protocol Identification Number
NCT03364439
Brief Title
R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Italiana Linfomi - ETS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
DLBCL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One arm for all patients
Arm Type
Experimental
Arm Description
Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21.
Intervention Type
Drug
Intervention Name(s)
Treatment plan
Intervention Description
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)
Primary Outcome Measure Information:
Title
PFS Progression Free Survival
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
OS Overall Survival
Description
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
Time Frame
48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Giuseppina Cabras
Organizational Affiliation
Ospedale Businco di Cagliari
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.O. Niguarda
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Facility Name
Centro di Riferimento Oncologico della Basilicata
City
Rionero in Vulture
State/Province
PZ
ZIP/Postal Code
85028
Country
Italy
Facility Name
A.O. SS. Antonio e Biagio e C. Arrigo
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Centro di riferimento Oncologico Oncologia Medica A
City
Aviano
Country
Italy
Facility Name
Ospedale Degli Infermi - S.C. Oncologia
City
Biella
Country
Italy
Facility Name
A.O. Spedali Civili di Brescia - Ematologia
City
Brescia
Country
Italy
Facility Name
PO Perrino
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
Ospedale Businco
City
Cagliari
Country
Italy
Facility Name
Ospedale di Castelfranco Veneto - Ematologia
City
Castelfranco Veneto
Country
Italy
Facility Name
Osp.Generale Di Zona Valduce
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
Osp. San Carlo Borromeo Divisione di Oncologia Medica
City
Milano
Country
Italy
Facility Name
A.O. Universitaria Maggiore Della Carita' Di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
AOU di Parma UO Ematologia e CTMO
City
Parma
Country
Italy
Facility Name
Ausl Di Piacenza
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Facility Name
AO Arcispedale S.Maria Nuova Ematologia
City
Reggio Emilia
Country
Italy
Facility Name
Istituto Clinica Humanitas
City
Rozzano (MI)
Country
Italy
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino - SC Ematologia
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
City
Torino
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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