Shortened vs standard chemotherapy combined with immunotherapy for the initial treatment of patients with high tumor burden Follicular Lymphoma A randomized, open label, phase III study by Fondazione Italiana Linfomi.

Start 1 Dec 2021 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 54 sites · Protocol FIL_FOLL19

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruitment ended

Participants planned 602

Countries 1

Sites 54

Follicular Lymphoma

To demonstrate that, in patients with newly diagnosed, advanced stage Follicular Lymphoma (FL) with high tumor burden according to the 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 d…

Key facts

Sponsor: Fondazione Italiana Linfomi Ets
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
Trial duration: 1 Dec 2021 → ongoing
Decision date (initial): 2024-11-27
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-511636-27-00
EudraCT number: 2020-003277-22
ClinicalTrials.gov: NCT05058404

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

Secondary objectives 11

to compare the response rates between the Standard and Experimental treatment;
to compare the rate of adverse events between the Standard and Experimental treatment
to compare a shortened vs full dose program in terms of change in quality of life (QoL) measured through the Patients Reported Outcomes (PROs) by means of the FACT-Lym questionnaire;
to recognized patients’ characteristics and biomarkers that help in identifying patients suitable for shortened chemotherapy treatment;
to assess the role of minimal residual disease (MRD) in predicting patient outcome;
to assess the role of cell-free tumor DNA (cfDNA) analysis in predicting patient outcome;
to assess whether cfDNA analysis could be used to monitor residual disease;
to correlate response and survival with clinical and biologic prognostic factors;
to assess long-term outcome of the patients;
to complement heterogeneity information provided through radiomics analysis to total metabolic tumor value (TMTV) to correlate it to the prognosis and evaluate the correlation of TMTV/radiomics at baseline with response;
to evaluate and to compare Lugano classification and TMTV/radiomics analysis results obtained from PET studies reconstructed both with ordered subset expectation maximization (OSEM) - w/wo point spread function (PSF) - and regularized reconstruction (RR) algorithm.

Conditions and MedDRA coding

Follicular Lymphoma

Version	Level	Code	Term	System organ class
24.0	LLT	10067070	Follicular B-cell non-Hodgkin´s lymphoma	10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

Histologically documented diagnosis of grade 1-2 or 3a follicular lymphona or classic follicular lymphoma, as defined in the 4 th and 5 th editions of the World Health Organization (WHO) classification respectively;
Age ≥ 18 years
ECOG performance status 0-2
No previous immunochemotherapy for the lymphoma (localized radiotherapy or rituximab monotherapy with max of 4 doses are allowed);
Ann Arbor stage II-IV
High tumor burden as per 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; - ECOG-PS > 1; - LDH > upper limit of normality (ULN); - β2-microglobulin > 3 mg/L. In the absence of at least one of the GELF criteria, the presence of extranodal disease applies provided that the bone marrow is not the only extranodal site
At least one site of measurable nodal disease at baseline ≥ 1.5 cm in the longest transverse diameter as determined by CT scan (MRI is allowed if CT scan cannot be performed); or evaluable disease at baseline FDG-PET scan (at least one metabolic active site of disease)
Adequate hematological counts (unless due to bone marrow involvement by lymphoma) defined as follows: a. Absolute Neutrophil count (ANC) > 1.5 x 109 /L; b. Platelet count ≥ 80 x 109 /L ; c. Hemoglobin ≥ 10 g/dL
Adequate renal function defined as creatinine ≤ 2 mg/dL, unless secondary to lymphoma;
Adequate hepatic function defined as bilirubin ≤ 2 mg/dL, unless secondary to lymphoma or Gilbert syndrome
LVEF > 50% at bidimensional echocardiogram (mandatory only for patients receiving R/G-CHOP);
Life expectancy ≥ 6 months;
Subject understands and voluntarily signs an informed consent form approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures;
Subject must be able to adhere to the study visit schedule and other protocol requirements
Women of childbearing potential (WOCBP) and men must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and 12 months after last rituximab dose or 18 months after last obinutuzumab dose. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control (failure rate of less than 1%) e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner. The use of condoms by male patients is required (even if surgically sterilized, i.e., status post vasectomy) unless the female partner is permanently sterile. Full sexual abstinence is admitted when this is in line with the preferred and usual lifestyle of the subject, for the same time period planned for other methods of birth control (see above). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods for the female partner) and withdrawal are not acceptable methods of contraception)

Exclusion criteria 9

Histological diagnosis different from grade 1-3a or cFL, as defined in the WHO classification (4 th and 5 th editions);
Suspect or clinical evidence of 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 SARSCoV-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 PCR negative for HCV-RNA
HIV seropositivity;
Women who are pregnant or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Progression-free survival (PFS).

Secondary endpoints 6

Overall Survival (OS);
Event Free Survival (EFS)
Response rate (overall [ORR] and complete [CRR], according to Cheson 2014);
Molecular response evaluated by polymerase chain reaction (PCR) assessment of Bcl2/IgH rearrangement;
Safety of the treatment according to the current version of the CTCAE
Quality of life evaluated through the Patient reported outcomes (PROs) by means of the FACT-Lym questionnaire

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 8

Cyclophosphamide

SCP106382672 · ATC

Active substance: Cyclophosphamide
Route of administration: INTRAVENOUS
Max daily dose: 750 mg/m2 milligram(s)/square meter
Max total dose: 3000 mg/m2 milligram(s)/square meter
Max treatment duration: 12 Week(s)
Authorisation status: Authorised
ATC code: L01AA01 — CYCLOPHOSPHAMIDE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Obinutuzumab

SCP276011 · ATC

Active substance: Obinutuzumab
Substance synonyms: RO5072759, AFUTUZUMAB, RO-5072759, RG-7159, GA-101, RO 5072759
Route of administration: INTRAVENOUS
Max daily dose: 1000 mg milligram(s)
Max total dose: 22000 mg milligram(s)
Max treatment duration: 30 Month(s)
Authorisation status: Authorised
ATC code: L01XC15 — OBINUTUZUMAB
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/12/1054
Modified vs. Marketing Authorisation: No

Doxorubicin Hydrochloride

SCP138158 · ATC

Active substance: Doxorubicin Hydrochloride
Route of administration: INTRAVENOUS
Max daily dose: 50 mg/m2 milligram(s)/square meter
Max total dose: 200 mg/m2 milligram(s)/square meter
Max treatment duration: 12 Week(s)
Authorisation status: Authorised
ATC code: L01DB01 — DOXORUBICIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/06/410
Modified vs. Marketing Authorisation: No

Bendamustine Hydrochloride

SCP20211730 · ATC

Active substance: Bendamustine Hydrochloride
Route of administration: INTRAVENOUS
Max daily dose: 90 mg/m2 milligram(s)/square meter
Max total dose: 720 mg/m2 milligram(s)/square meter
Max treatment duration: 16 Week(s)
Authorisation status: Authorised
ATC code: L01AA09 — BENDAMUSTINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prednisolone

SCP107216203 · ATC

Active substance: Prednisolone
Substance synonyms: (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
Route of administration: ORAL
Max daily dose: 40 mg/m2 milligram(s)/square meter
Max total dose: 800 mg/m2 milligram(s)/square meter
Max treatment duration: 12 Week(s)
Authorisation status: Authorised
ATC code: H02AB07 — PREDNISONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vinorelbine

SCP1137788 · ATC

Active substance: Vinorelbine
Route of administration: INTRAVENOUS
Max daily dose: 2 mg/m2 milligram(s)/square meter
Max total dose: 8 mg/m2 milligram(s)/square meter
Max treatment duration: 12 Week(s)
Authorisation status: Authorised
ATC code: L01CA02 — VINCRISTINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rituximab

SCP24437829 · ATC

Active substance: Rituximab
Substance synonyms: CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Route of administration: INTRAVENOUS
Max daily dose: 375 mg/m2 milligram(s)/square meter
Max total dose: 7500 mg/m2 milligram(s)/square meter
Max treatment duration: 32 Month(s)
Authorisation status: Authorised
ATC code: L01XC02 — RITUXIMAB
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/23/2816
Modified vs. Marketing Authorisation: No

Rituximab

SUB12570MIG · Substance

Active substance: Rituximab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 1400 mg milligram(s)
Max total dose: 26600 mg milligram(s)
Max treatment duration: 32 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/23/2816
Modified vs. Marketing Authorisation: No

Comparator 8

Prednisone

SUB10020MIG · Substance

Active substance: Prednisone
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 40 mg/m2 milligram(s)/square meter
Max total dose: 1200 mg/m2 milligram(s)/square meter
Max treatment duration: 18 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cyclophosphamide

SUB06859MIG · Substance

Active substance: Cyclophosphamide
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 750 mg/m2 milligram(s)/square meter
Max total dose: 4500 mg/m2 milligram(s)/square meter
Max treatment duration: 18 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Obinutuzumab

SUB32751 · Substance

Active substance: Obinutuzumab
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 1000 mg milligram(s)
Max total dose: 22000 mg milligram(s)
Max treatment duration: 30 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/12/1054
Modified vs. Marketing Authorisation: No

Bendamustine

SUB05707MIG · Substance

Active substance: Bendamustine
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 90 mg/m2 milligram(s)/square meter
Max total dose: 1080 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rituximab

SUB12570MIG · Substance

Active substance: Rituximab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 375 mg/m2 milligram(s)/square meter
Max total dose: 7500 mg/m2 milligram(s)/square meter
Max treatment duration: 32 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/23/2816
Modified vs. Marketing Authorisation: No

Vincristine

SUB00059MIG · Substance

Active substance: Vincristine
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 2 mg milligram(s)
Max total dose: 12 mg milligram(s)
Max treatment duration: 18 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rituximab

SUB12570MIG · Substance

Active substance: Rituximab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Max daily dose: 1400 mg milligram(s)
Max total dose: 26600 mg milligram(s)
Max treatment duration: 32 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/23/2816
Modified vs. Marketing Authorisation: No

Doxorubicin

SUB06391MIG · Substance

Active substance: Doxorubicin
Pharmaceutical form: INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 50 mg/m2 milligram(s)/square meter
Max total dose: 300 mg/m2 milligram(s)/square meter
Max treatment duration: 18 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/06/410
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione Italiana Linfomi Ets

Sponsor organisation: Fondazione Italiana Linfomi Ets
Address: Piazza Filippo Turati 5
City: Alexandria
Postcode: 15121
Country: Italy

Scientific contact point

Organisation: Fondazione Italiana Linfomi Ets
Contact name: Stefano Luminari, MD

Public contact point

Organisation: Fondazione Italiana Linfomi Ets
Contact name: Uffici Studi FIL

Locations

1 EU/EEA country · 54 investigational sites

By country

Country	MS status	Planned subjects	Sites
Italy	Ongoing, recruitment ended	602	54
Rest of world	—	0	—

Investigational sites

Italy

54 sites · Ongoing, recruitment ended

Careggi University Hospital

Unità funzionale di Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence

Azienda Ospedaliera Papardo

S.C. Ematologia, Viale Ferdinando Stagno D'Alcontres Contrada Papardo, 98158, Messina

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione, Viale Del Policlinico 155, 00161, Rome

Azienda Ospedaliera Santa Croce E Carle

S.C. di Ematologia e Trapianto di Midollo Osseo, Via Michele Coppino 26, 12100, Cuneo

Istituto Oncologico Veneto

SC Ematologia, Via Dei Carpani 16/z, 31033, Castelfranco Veneto

ASL di Salerno - PO A. Tortora

U.O. Onco-ematologia, Via Alcide de Gasperi, Italy

Azienda Socio Sanitaria Territoriale Della Valle Olona

S.C. Ematologia, Via Arnaldo Da Brescia 1, 21052, Busto Arsizio

Azienda Ospedaliera S Maria Di Terni

SC Oncoematologia, Viale Tristano Di Joannuccio 1, 05100, Terni

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

U.O. Ematologia con Trapianto, Piazza Giulio Cesare 11, Italy, Bari

Azienda Ospedaliero Universitaria Parma

UO Ematologia e CTMO, Viale Antonio Gramsci 14, 43126, Parma

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

Ematologia, Via Piero Maroncelli 40, 47014, Meldola

Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania

Ematologia, Via Santa Sofia 78, 95123, Catania

Azienda Ospedaliera Universitaria Senese

U.O.C. Ematologia, Strada Delle Scotte 14, 53100, Siena

Azienda Ospedaliero Universitaria Pisana

U.O. Ematologia, Via Roma 67, 56126, Pisa

Azienda Ospedaliera Universitaria di Ferrara

Ematologia e fisiopatologia della coagulazione, Via Aldo Moro 8, Cona, Ferrara

Azienda Sanitaria Locale Roma 2

UOC Ematologia, Piazzale Dell' Umanesimo 10, 00144, Rome

Azienda Ospedaliero Universitaria Delle Marche

Clinica di Ematologia, Via Conca 71, 60126, Ancona

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Ematologia, Largo Francesco Vito 1, 00168, Rome

Azienda Ospedaliera Regionale San Carlo

U.O. Ematologia, Via Potito Petrone, 85100, Potenza

Azienda Ulss n.3 Serenissima – Ospedale di Mirano

UOC di Oncologia ed Ematologia Oncologica, Via Don Giacobbe Sartor, 4, Mirano

Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS

Ematologia, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo

IRCCS Ospedale Policlinico San Martino

Ematologia, Largo Rosanna Benzi 10, 16132, Genoa

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

SC Ematologia, Corso Bramante 88, 10126, Turin

Azienda USL IRCCS Di Reggio Emilia

Ematologia, Viale Risorgimento 80, 42123, Reggio Emilia

AORN San Giuseppe Moscati Avellino

S.C. Ematologia e Trapianto emopoietico, Contrada Amoretta, 83100, Avellino

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

Ematologia Universitaria, Corso Bramante 88, 10126, Turin

Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria

SCDU Ematologia, Via Venezia 16, 15121, Alexandria

Fondazione IRCCS Policlinico San Matteo

Div. di Ematologia, Viale Camillo Golgi 19, 27100, Pavia

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Ematologia, Via Francesco Sforza 28, 20122, Milan

Azienda Sanitaria Territoriale Di Ascoli Piceno

UOC Ematologia, Via Degli Iris 1, 63100, Ascoli Piceno

Azienda Ospedaliero-Universitaria Maggiore Della Carita

SCDU Ematologia, Corso Giuseppe Mazzini 18, 28100, Novara

Azienda Unita Locale Socio Sanitaria N. 1 Dolomiti

UOC Oncologia, Viale Europa 22, 32100, Belluno

Azienda USL Toscana Centro

SOS Oncoematologia, Via Suor Niccolina Infermiera 20/22, 59100, Prato

Fondazione IRCCS San Gerardo Dei Tintori

Ematologia, Via Giovanni Battista Pergolesi 33, 20900, Monza

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Ematologia, Via Del Vespro 129, 90127, Palermo

Azienda Unita Sanitaria Locale Di Piacenza

U.O. Ematologia, Via Giuseppe Taverna 49, 29121, Piacenza

Ospedale Di Sassuolo S.p.A.

Day Hospital Oncologico, Via Francesco Ruini 2, 41049, Sassuolo

Azienda Ospedaliera di Padova

Ematologia, Via Nicolo' Giustiniani 2, 35128, Padova

Azienda Socio Sanitaria Territoriale Ovest Milanese

U.O.C. Ematologia, Via Papa Giovanni Paolo II, 20025, Legnano

Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona

U.O. Ematologia, Largo Citta' D'ippocrate 1, 84131, Salerno

Istituto Oncologico Veneto

Oncologia 1, Via Gattamelata 64, 35128, Padova

Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario

Medicina Interna, Via Stelvio N 25, 23100, Sondrio

Centro Di Riferimento Oncologico Di Aviano

Divisione di Oncologia e dei Tumori immuno-correlati, Via Franco Gallini 2, 33081, Aviano

Ospedale San Raffaele S.r.l.

Unità Linfomi - Dipartimento Oncoematologia, Via Olgettina 60, 20132, Milan

ASST Grande Ospedale Metropolitano Niguarda

SC Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan

Azienda Unita Sanitaria Locale Della Romagna

U.O. di Ematologia, Viale Luigi Settembrini 2, 47923, Rimini

Azienda Sanitaria Locale Br

U.O. Ematologia e Trapianti di Midollo, Via Napoli 8, 72100, Brindisi

Azienda Unita Sanitaria Locale Della Romagna

Ematologia, Via Alcide De Gasperi 8, 48121, Ravenna

Azienda Sanitaria Locale Di Pescara

UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi, Via Renato Paolini 47, 65124, Pescara

Azienda Sanitaria Universitaria Giuliano Isontina

SC Ematologia, Via Costantino Costantinides 2, 34128, Trieste

Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo

Oncoematologia, Via Antonio Di Rudini' 8, 20142, Milan

Azienda USL Toscana Centro

SOS Ematologia clinica e oncoematologia, Piazza Di Santa Maria Nuova 1, 50122, Florence

Azienda Sanitaria Locale Della Provincia Di Biella

SSD Ematologia, Via Dei Ponderanesi 2, 13875, Ponderano

Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana

S.C di Ematologia, Piazzale Ospedale 1, 31100, Treviso

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Italy	2021-12-01		2021-12-01	2025-08-05

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 26 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_FIL_FOLL19_Protocol_2024-511636-27-00_redacted	2.0
Recruitment arrangements (for publication)	Declaration of minimum requirements	1.0
Recruitment arrangements (for publication)	K1_FIL_FOLL19_informed consent_patient recruitment procedure	1
Subject information and informed consent form (for publication)	L1_FIL_FOLL19_Letter to General Practitioner	2.0
Subject information and informed consent form (for publication)	L1_FIL_FOLL19_Patient consent form	2.0
Subject information and informed consent form (for publication)	L1_FIL_FOLL19_Patient consent form_biological study	1.0
Subject information and informed consent form (for publication)	L1_FIL_FOLL19_Patient Information sheet_biological study_redacted	1.0
Subject information and informed consent form (for publication)	L1_FIL_FOLL19_Patient Information sheet_redacted	2.0
Subject information and informed consent form (for publication)	L1_FIL_FOLL19_Privacy Information and consent form for patient_redacted	2.0
Subject information and informed consent form (for publication)	L1_FIL_FOLL19_Privacy Information and consent form for pregnancy_redacted	2.0
Summary of Product Characteristics (SmPC) (for publication)	Document non required under CTD	1
Summary of Product Characteristics (SmPC) (for publication)	Document non required under CTD	1
Summary of Product Characteristics (SmPC) (for publication)	Document non required under CTD	1
Summary of Product Characteristics (SmPC) (for publication)	Document non required under CTD	1
Summary of Product Characteristics (SmPC) (for publication)	Document non required under CTD	1
Summary of Product Characteristics (SmPC) (for publication)	Document non required under CTD	1
Summary of Product Characteristics (SmPC) (for publication)	Document non required under CTD	1.0
Summary of Product Characteristics (SmPC) (for publication)	Document non required under CTD	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Bendamustine_it	1.0
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Ciclofosfamide_it	1.0
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Doxorubicina_it	1.0
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Obinutuzumab_it	1.0
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Prednisone_it	1.0
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Rituximab_it	1.0
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Rituximab_it	1.0
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Vincristina_it	1.0

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-11-06	Italy	Acceptable 2024-11-22	2024-11-27
2	SUBSTANTIAL MODIFICATION	SM-1	2026-01-14	Italy	Acceptable	2026-02-16
3	SUBSTANTIAL MODIFICATION	SM-2	2026-03-06	Italy	Acceptable	2026-03-24

Shortened vs standard chemotherapy combined with immunotherapy for the initial treatment of patients with high tumor burden Follicular Lymphoma A randomized, open label, phase III study by Fondazione Italiana Linfomi.

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 11

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 15

Exclusion criteria 9

Endpoints

Primary endpoints 1

Secondary endpoints 6

Investigational products

Test 8

Comparator 8

Sponsors and contacts

Fondazione Italiana Linfomi Ets

Scientific contact point

Public contact point

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 26 files

Application history

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