Shortened vs Standard Chemotherapy Combined With Immunotherapy for the Initial Treatment of Patients With High Tumor Burden Follicular Lymphoma

NCT05058404 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: FIL_FOLL19
• Study Type: interventional
• Target: 605
• Locations: 1 country
• Sites: 71

Brief Summary

FIL\_FOLL19 is an open-label, multicenter, randomized phase III trial. The sponsor of this clinical trial is Fondazione Italiana Linfomi (FIL). The Primary Objective of the study is to demonstrate that, in patients with newly diagnosed, advanced stage Follicular Lymphoma (FL) with high tumor burden according to the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria, a treatment strategy that reduces the number of chemotherapy cycles in case of early response to immunochemotherapy is not inferior compared to standard therapy at full dose in terms of Progression-Free Survival (PFS).

Conditions

Follicular Lymphoma

Keywords

High tumor burden Follicular Lymphoma; Shortened vs standard chemotherapy; Immunotherapy; Initial treatment

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be measured from the time of study entry to documented progression or to the patient's death as a result of any causes. Subjects with incomplete follow-up or with no disease evaluation will be censored at the date of last available documented status of freedom from failure.

  The endpoint will be assessed from the beginning of the study up to 104 months (end of study)

Secondary Outcomes (7)

• Overall Survival (OS)

  The endpoint will be assessed from the beginning of the study up to 104 months (end of study)

• Event-Free Survival (EFS)

  The endpoint will be assessed from the beginning of the study up to 104 months (end of study)

• Overall Response rate (ORR)

  The endpoint will be assessed from the beginning of the study up to 104 months (end of study)

• Complete response rate (CRR)

  The endpoint will be assessed from the beginning of the study up to 104 months (end of study)

• Molecular response

  The endpoint will be assessed from the beginning of the study up to 104 months (end of study)

Study Arms (2)

Standard arm (A)

EXPERIMENTAL

Patients will start immunochemotherapy with one of the approved regimens (R-CHOP, R-Bendamustine, G-CHOP, G-Bendamustine, G-CVP). Patients randomized to Arm A will receive an induction immunochemotherapy at full doses (standard schedule). After cycle 4, patients will be assessed for response and will complete their planned therapy if at least a stable disease is confirmed. At the end of induction responding patients (CR, PR) will be addressed to a standard anti-CD20 maintenance (1 dose every 8 weeks for two years) with the same Monoclonal Antibody (MoAb) given during induction.

Drug: Immunochemotherapy regimen: Rituximab-bendamustine (Arm A); Drug: Immunochemotherapy regimen: R-CHOP (Arm A); Drug: Immunochemotherapy regimen: G-bendamustine (Arm A); Drug: Immunochemotherapy regimen: G-CHOP (Arm A); Drug: Immunochemotherapy regimen: G-CVP (Arm A)

Experimental arm (B)

EXPERIMENTAL

Patients will start immunochemotherapy with one of the approved regimens (R-CHOP, R-Bendamustine, G-CHOP, G-Bendamustine, G-CVP). Patients randomized to Arm B will start their induction treatment with 4 cycles of the immunochemotherapy standard dose chosen by the physician: after cycle 4, patients will be assessed for response and will proceed with subsequent treatment based on the quality of their response. Specifically: * Patients achieving a CR will receive a shortened treatment: in detail, they won't receive any further chemotherapy but will complete induction with 4 additional cycles of only the Monoclonal Antibody (MoAb) given during the first four cycles; * In case if response less than CR, (PR,SD), patients will complete treatment as planned for patients in Arm A. At the end of induction responding patients (CR, PR) will be addressed to a standard anti-CD20 maintenance (1 dose every 8 weeks for two years) with the same Monoclonal Antibody (MoAb) given during induction.

Drug: Immunochemotherapy regimen: Rituximab-bendamustine (Arm B); Drug: Immunochemotherapy regimen: R-CHOP (Arm B); Drug: Immunochemotherapy regimen: G-bendamustine (Arm B); Drug: Immunochemotherapy regimen: G-CHOP (Arm B); Drug: Immunochemotherapy regimen: G-CVP (Arm B)

Interventions

Immunochemotherapy regimen: Rituximab-bendamustine (Arm A) DRUG

Arm A (Standard arm): 4 cycles of Rituximab-bendamustine Q28 (28-days cycles); Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of R-bendamustine Q28 + 2 cycles Q28 of rituximab; Both Arms: Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in stable disease (SD) at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.

Also known as: R-Benda, R-bendamustine

Standard arm (A)

Immunochemotherapy regimen: Rituximab-bendamustine (Arm B) DRUG

Arm B (Experimental arm): 4 cycles of Rituximab-bendamustine Q28 (28-days cycles); After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified: * if in CR: patients will receive no more chemotherapy but will complete induction with the MoAb only, in this case: 4 cycles of rituximab; * if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of R-bendamustine Q28 + 2 cycles Q28 of rituximab; Both Arms: Whichever the regimen, in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.

Also known as: R-Benda, R-bendamustine

Experimental arm (B)

Immunochemotherapy regimen: R-CHOP (Arm A) DRUG

Arm A (Standard arm): 4 cycles of R-CHOP Q21 (21-days cycles); R-CHOP = Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of R-CHOP Q21 + 2 cycles Q21 of rituximab; Both Arms: Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in stable disease (SD) at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion: these patients will be included in the analysis planned by the study.

Also known as: R-CHOP

Standard arm (A)

Immunochemotherapy regimen: R-CHOP (Arm B) DRUG

Arm B (Experimental arm): 4 cycles of R-CHOP Q21 (21-days cycles); R-CHOP = Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone After cycle 4 patients will undergo an early restaging: induction therapy shall be completed based on the response achieved and on the treatment chosen: * if in CR: patients will receive no more chemotherapy but will complete induction with the MoAb only, in this case: 4 cycles of rituximab; * if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of R-CHOP Q21+ 2 cycles Q21of rituximab Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 MoAb used for induction. Patients in both arms with progressive disease at any time and patients in SD at the EOI shall be considered for salvage therapy at clinician discretion: these patients will be included in the analysis.

Also known as: R-CHOP

Experimental arm (B)

Immunochemotherapy regimen: G-bendamustine (Arm A) DRUG

Arm A (Standard arm): 4 cycles of G-bendamustine Q28 (28-days cycles); G-Bendamustine = Obinutuzumab and Bendamustine Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of G-bendamustine Q28 (28-days cycles); Both Arms: Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in Stable Disease SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.

Also known as: G-Benda

Standard arm (A)

Immunochemotherapy regimen: G-bendamustine (Arm B) DRUG

Arm B (Experimental arm): 4 cycles of G-bendamustine Q28 (28-days cycles); G-Bendamustine = Obinutuzumab and Bendamustine After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified: * if in CR: patients will receive no more chemotherapy but will complete induction with the Monoclonal Antibody (MoAb) only, in this case 2 cycles of obinutuzumab; * if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of G-bendamustine Q28; Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.

Also known as: G-Benda

Experimental arm (B)

Immunochemotherapy regimen: G-CHOP (Arm A) DRUG

Arm A (Standard arm): 4 cycles of G-CHOP Q21 (21-days cycles) G-CHOP = Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of G-CHOP Q21 + 2 cycles Q21 of obinutuzumab; Both Arms: Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in stable disease (SD) at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.

Also known as: G-CHOP

Standard arm (A)

Immunochemotherapy regimen: G-CHOP (Arm B) DRUG

4 cycles of G-CHOP Q21 (21-days cycles) G-CHOP = Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified: * if in CR: patients will receive no more chemotherapy but will complete induction with the Monoclonal Antibody (MoAb) only, in this case: 4 cycles of obinutuzumab; * if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of G-CHOP Q21 + 2 cycles Q21 of obinutuzumab; Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 MoAb used for induction. Patients in both arms with progressive disease at any time and patients in SD at the EOI shall be considered for salvage therapy at clinician discretion.

Also known as: G-CHOP

Experimental arm (B)

Immunochemotherapy regimen: G-CVP (Arm A) DRUG

Arm A (Standard arm): 4 cycles of G-CVP Q21 (21-days cycles) G-CVP = Obinutuzumab, Cyclophosphamide, Vincristine, Prednisone. Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 4 cycles of G-CVP Q21; Both Arms: Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in stable disease SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.

Also known as: G-CVP

Standard arm (A)

Immunochemotherapy regimen: G-CVP (Arm B) DRUG

Arm B (Experimental arm): 4 cycles of G-CVP Q21 (21-days cycles) G-CVP = Obinutuzumab, Cyclophosphamide, Vincristine, Prednisone. After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified: * if in CR: patients will receive no more chemotherapy but will complete induction with the Monoclonal Antibody (MoAb) only, in this case: 4 cycles of obinutuzumab; * if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 4 cycles of G-CVP Q21 Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 MoAb used for induction. Patients in both arms with progressive disease at any time and patients in SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.

Also known as: G-CVP

Experimental arm (B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented diagnosis of CD20+ Follicular lymphoma grade 1-2 or 3a, as defined in the 2017 edition of the World Health Organization (WHO) classification;
• Age ≥ 18 years;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix B);
• No previous immunochemotherapy for the lymphoma (localized radiotherapy or rituximab monotherapy with max of 4 doses are allowed);
• Ann Arbor stage II-IV (Appendix A);
• High tumor burden as per Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria defined as the presence of at least one of the following:
• systemic symptoms;
• Tumor bulk (any nodal or extranodal tumor mass with diameter \> 7 cm);
• involvement of ≥ 3 nodal sites, each with a diameter ≥ 3 cm;
• splenomegaly;
• compressive syndrome (organ compression);
• serous effusion;
• circulant malignant cells;
• cytopenia;
• Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) \> 1;

You may not qualify if:

• Histological diagnosis different from FL grade 1-3a WHO 2017 classification;
• Suspect or clinical evidence of Central Nervous System (CNS) involvement by lymphoma;
• Contraindication to the use of anti-CD20 monoclonal antibodies;
• Subject has received any anticancer therapy (chemotherapy, immunotherapy, investigational therapy, including targeted small molecule agents) within 14 days prior to the first dose of study drug;
• Noteworthy history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent;
• Any history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uterine; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; limited stage surgically removed breast cancer or adequately treated with radiation therapy; limited stage prostate carcinoma surgically removed or adequately treated with radiation therapy; previous malignancy confined and surgically resected with curative intent;
• Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
• Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2;
• Chronic or acute hepatitis B (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e., HBsAg negative, HBsAb positive and HBcAb negative) or positive HBcAb from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV- DNA) are eligible. Patients with presence of HCV antibody are eligible only if Polymerase Chain Reaction (PCR) negative for HCV-RNA;
• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (71)

Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia

Barletta, Barletta Andria Trani, 76121, Italy

Location

Casa Sollievo della Sofferenza - U.O. Ematologia

San Giovanni Rotondo, Foggia, 71013, Italy

Location

IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L. - Ematologia

Meldola, Forlì - Cesena, 47014, Italy

Location

A.O. C. Panico - U.O.C Ematologia e Trapianto

Tricase, Lecce, 73039, Italy

Location

Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico

Sassuolo, Modena, 41049, Italy

Location

ASST MONZA Ospedale S. Gerardo - Ematologia

Monza, Monza E Brianza, 20900, Italy

Location

IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati

Aviano, Pordenone, 33081, Italy

Location

Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia

Pagani, Salerno, 84016, Italy

Location

Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia

Candiolo, Torino, 10060, Italy

Location

Ospedale di Castelfranco Veneto - Ematologia

Castelfranco Veneto, Treviso, 31033, Italy

Location

ASST Valle Olona - Ospedale di Circolo di Busto Arsizio - S.C. Ematologia

Busto Arsizio, Varese, 21052, Italy

Location

Ospedale Dell'Angelo - U.O. Ematologia

Mestre, Venezia, 30174, Italy

Location

USLL13 - Dipartimento di Scienze Mediche UOC di Oncologia ed Ematologia Oncologica

Mirano, Venezia, 30035, Italy

Location

A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia

Alessandria, 15121, Italy

Location

AOU Ospedali Riuniti - Clinica di Ematologia

Ancona, 60126, Italy

Location

Ospedale C.e G. Mazzoni - U.O.C. di Ematologia

Ascoli Piceno, 63100, Italy

Location

Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico

Avellino, 83100, Italy

Location

AOU Policlinico Consorziale - U.O. Ematologia con Trapianto

Bari, 70124, Italy

Location

IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia

Bari, Italy

Location

Ospedale S. Martino - UOC Oncologia

Belluno, 32100, Italy

Location

A.O.R.N. Gaetano Rummo - DH Ematologico

Benevento, 82100, Italy

Location

Nuovo Ospedale degli Infermi - SSD Ematologia

Biella, 13875, Italy

Location

ASST Spedali Civili di Brescia - Ematologia

Brescia, Italy

Location

Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo

Brindisi, 72100, Italy

Location

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele Presidio Ospedale Ferrarotto - Ematologia

Catania, 95125, Italy

Location

AO Pugliese Ciaccio - SOC Ematologia

Catanzaro, Italy

Location

Azienda Ospedaliera di Cosenza - UOC Ematologia

Cosenza, 87100, Italy

Location

A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo

Cuneo, Italy

Location

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione

Ferrara, 44124, Italy

Location

Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia

Florence, 50141, Italy

Location

Ospedale San Giovanni di Dio - SOS Ematologia clinica e oncoematologia ASL Toscana Centro

Florence, 50143, Italy

Location

Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia - Ematologia

Genova, 16132, Italy

Location

Ospedale Vito Fazzi - Ematologia

Lecce, 73100, Italy

Location

Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia

Messina, 98158, Italy

Location

Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia

Milan, 20132, Italy

Location

ASST Santi Paolo e Carlo - Onco - Ematologia

Milan, 20153, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

Milan, 20162, Italy

Location

Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia

Milan, Italy

Location

AOU Universitа degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia

Napoli, 80131, Italy

Location

AOU Maggiore della Caritа di Novara - SCDU Ematologia

Novara, 28100, Italy

Location

I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1

Padua, 35128, Italy

Location

AOU di Padova - Ematologia

Padua, Italy

Location

AOU Policlinico Giaccone - Ematologia

Palermo, 90127, Italy

Location

A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

Palermo, 90146, Italy

Location

UO Ematologia e CTMO - AOU di Parma

Parma, 43126, Italy

Location

IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia

Pavia, 27100, Italy

Location

P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi

Pescara, 65124, Italy

Location

Ospedale Guglielmo da Saliceto - U.O.Ematologia

Piacenza, 29121, Italy

Location

AOU Pisana - U.O. Ematologia

Pisa, 56126, Italy

Location

A.O.R. "San Carlo" - U.O. Ematologia

Potenza, 85100, Italy

Location

Ospedale S. Stefano - SOS Oncoematologia, ASL Toscana Centro

Prato, 59100, Italy

Location

Ospedale delle Croci - Ematologia

Ravenna, 48121, Italy

Location

Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia

Reggio Calabria, Italy

Location

Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia

Reggio Emilia, 42123, Italy

Location

Ospedale degli Infermi di Rimini - U.O. di Ematologia

Rimini, 47923, Italy

Location

Policlinico Tor Vergata - Ematologia

Roma, 00133, Italy

Location

Ospedale S. Eugenio - UOC Ematologia

Roma, 00144, Italy

Location

Ospedale S. Camillo - Ematologia

Roma, 00152, Italy

Location

Policlinico Umberto I - Universitа "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione

Roma, 00161, Italy

Location

Universitа Cattolica S. Cuore - Ematologia

Roma, 00168, Italy

Location

Ospedale di Rovigo - S.O.S. Oncoematologia

Rovigo, 45100, Italy

Location

Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia

Salerno, 84131, Italy

Location

AOU di Sassari - Ematologia

Sassari, 07100, Italy

Location

AOU Senese - U.O.C. Ematologia

Siena, 53100, Italy

Location

Azienda Ospedaliera della Valtellina e della Valchiavenna P.O. Sondrio - Medicina Interna - Centro Malattie del Sangue P.O. Sondrio

Sondrio, 23100, Italy

Location

A.O. S. Maria di Terni - S.C. Oncoematologia

Terni, 05100, Italy

Location

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

Torino, 10126, Italy

Location

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

Torino, 10126, Italy

Location

San Giovanni Bosco - ASL Cittа di Torino - SSD di Ematologia e Malattie Trombotiche

Torino, 10154, Italy

Location

Ospedale Ca Foncello - S.C di Ematologia

Treviso, 31100, Italy

Location

Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia

Trieste, 34121, Italy

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

R-CHOP protocol

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Stefano Luminari, MD

  Reggio Emilia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, phase III, two arms randomized trial with a non-inferiority design with Progression-Free Survival (PFS) as primary endpoint. Patients who meet all eligibility criteria will be centrally randomized to one of the two treatment arms in a 1:1 ratio, using random sequences blocks of variable size. The web-based allocation process, completely concealed to researchers, will be stratified according Follicular Lymphoma International Prognostic Index 2 (FLIPI2) score (0-2, 3-5), chemotherapy regimen (CHOP, Bendamustine, CVP) and anti-CD20 Monoclonal Antibody (MoAb) (rituximab, obinutuzumab). A non-inferiority design has been adopted to demonstrate that a shortened exposure to chemotherapy in patients responding to the first four cycles of immunochemotherapy is not detrimental in terms of PFS compared to full dose standard treatment. The primary comparison will be done as an Intention To Treat (ITT) analysis including all randomized patients.

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 27, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: September 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (71)