NCT03364439

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_2

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2021

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

6.3 years

First QC Date

December 1, 2017

Last Update Submit

February 15, 2022

Conditions

Diffuse Large B Cell Lymphoma

Keywords

DLBCL

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • OS Overall Survival

    48 months

Study Arms (1)

One arm for all patients

EXPERIMENTAL

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

Drug: Treatment plan

Interventions

Treatment planDRUG

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)

One arm for all patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • HIV positivity
  • significant cardiopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

A.O. Niguarda

Milan, MI, 20162, Italy

Location

Centro di Riferimento Oncologico della Basilicata

Rionero in Vulture, PZ, 85028, Italy

Location

A.O. SS. Antonio e Biagio e C. Arrigo

Alessandria, 15121, Italy

Location

A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona

Ancona, 60126, Italy

Location

Centro di riferimento Oncologico Oncologia Medica A

Aviano, Italy

Location

Ospedale Degli Infermi - S.C. Oncologia

Biella, Italy

Location

A.O. Spedali Civili di Brescia - Ematologia

Brescia, Italy

Location

PO Perrino

Brindisi, 72100, Italy

Location

Ospedale Businco

Cagliari, Italy

Location

Ospedale di Castelfranco Veneto - Ematologia

Castelfranco Veneto, Italy

Location

Osp.Generale Di Zona Valduce

Como, 22100, Italy

Location

Osp. San Carlo Borromeo Divisione di Oncologia Medica

Milan, Italy

Location

A.O. Universitaria Maggiore Della Carita' Di Novara

Novara, 28100, Italy

Location

AOU di Parma UO Ematologia e CTMO

Parma, Italy

Location

Ausl Di Piacenza

Piacenza, 29121, Italy

Location

AO Arcispedale S.Maria Nuova Ematologia

Reggio Emilia, Italy

Location

Istituto Clinica Humanitas

Rozzano (MI), Italy

Location

A.O.U. Citta della Salute e della Scienza di Torino - SC Ematologia

Torino, 10126, Italy

Location

A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria

Torino, Italy

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Maria Giuseppina Cabras

    Ospedale Businco di Cagliari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2017

First Posted

December 6, 2017

Study Start

January 1, 2012

Primary Completion

April 1, 2018

Study Completion

March 18, 2021

Last Updated

March 3, 2022

Record last verified: 2022-02

Locations

IT(19)