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Study to Evaluate the Efficacy of Response-adapted Strategy in Follicular Lymphoma

Primary Purpose

Follicular Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
R-CHOP or R-bendamustine
Observation
Maintenance weekly x4
Ibritumomab Tiuxetan + Maintenance
Standard Maintenance
Sponsored by
Fondazione Italiana Linfomi - ETS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Histological diagnosis of B-Cell CD20+ Follicular Lymphoma (FL), grade I, II, IIIa according to the WHO 2008 classification
  • ECOG performance status 0-2
  • Age ≥ 18 years
  • Ann Arbor stage II-IV
  • FLIPI2>0
  • Presence of evaluable/measurable disease after diagnostic biopsy

  • At least one of the following criteria for defining active disease:

    • systemic symptoms
    • cytopenia due to bone marrow involvement
    • LDH> upper normal value
    • any nodal or extranodal tumor mass with a diameter >7cm
    • involvement of ≥ 3 nodal sites, each with a diameter of ≥ 3cm
    • extranodal disease
    • rapidly progressive disease
  • Life expectancy > 6 months
  • Left ventricular ejection fraction (LVEF) ³ 50%
  • Serum negativity for HIV
  • Serum negativity for HBsAg; HBcAb positive but HBV-DNA negative patients are allowed with mandatory Lamivudine prophylaxis.
  • Serum negativity for HCV, except for those patients without signs of active viral replication assessed by HCV-RNA copies
  • Serum creatinine < 2mg/dl , serum bilirubin < 1.5mg/dl, aspartate amino-transferase (AST/GOT) £ 2.5xUNV, alanine amino-transferase (ALT/GPT) £ 2.5xUNV, and alkaline phosphatase £ 4 times the upper limit of normal (unless the increase is attributed directly to the presence of tumour by the Investigator)
  • Patients with no previous treatment for the lymphoma with the exception of locoregional radiotherapy (IFRT)
  • Adequate measure adoption to avoid pregnancy
  • Written informed consent given at time of registration
  • Patient must be accessible for treatment and follow up.

Exclusion Criteria:

  • Histological diagnosis of :

    • any lymphoma other than follicular lymphoma and all CD20 negative B-cell lymphomas
    • grade III b follicular lymphoma
    • evidence of transformation to high grade lymphoma
  • Ann Arbor stage I
  • Suspect or clinical evidence of CNS involvement by lymphoma
  • History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer, low grade, early stage localized prostate cancer treated surgically with curative intent, good prognosis DCIS of the breast treated with lumpectomy alone with curative intent
  • Evidence of any severe active acute or chronic infection
  • Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy
  • Severe chronic obstructive pulmonary disease with hypoxemia
  • Severe diabetes mellitus difficult to control with adequate insulin therapy
  • Myocardial infarction within 6 months before study entry
  • Clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension, (resting diastolic blood pressure >115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV
  • HbsAg-positive, HIV-positive, or HCVAb-positive patients
  • Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
  • Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
  • Follicular lymphoma, showing a negative baseline PET scan.

Sites / Locations

  • Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Sede Di Meldola (Fc)
  • ASUR 8
  • Irccs Istituto Clinico Humanitas
  • Fondazione IRCCS Milano INT
  • Azienda Ospedaliera S. Gerardo Di Monza
  • Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
  • P.O. Umberto I
  • Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo
  • A.O. S. Maria di Terni
  • Ospedale Civile Ss. Antonio E Biagio Di Alessandria - Alessandria (Al)
  • A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona _
  • A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
  • A.O. Ospedale Degli Infermi
  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
  • Pres.Ospedal.Spedali Civili Brescia
  • Stabilimento "Perrino" - Brindisi -
  • Ospedale Armando Businco - Cagliari
  • A.O. Universitaria Ospedale Vittorio Emanuele Di Catania
  • Azienda Ospedaliera S. Croce E Carle Di Cuneo
  • A.O. Universitaria Careggi Di Firenze
  • A.O. Universitaria S. Martino Di Genova
  • Ematologia Ospedale Vito Fazzi
  • Presidio Ospedaliero - Matera -
  • Azienda Ospedaliera Papardo
  • Irccs Ospedale Maggiore Policlinico Di Milano
  • Ospedale Ca' Granda-Niguarda
  • A.O. Universitaria Policlinico Di Modena
  • Irccs Istituto Nazionale Tumori Fondazione Pascale
  • A.O. Universitaria Maggiore Della Carita' Di Novara
  • Ospedale San Francesco
  • A.O. Universitaria Policlinico Giaccone Di Palermo
  • A.O. "V. Cervello"
  • A O Universitaria di Parma
  • IRCCS Policlinico S. Matteo
  • Azienda Ospedaliera Di Perugia - Ospedale S. Maria Della Misericordia -
  • Ospedale Civile Spirito Santo
  • Ausl Di Piacenza
  • A.O. Universitaria Pisana
  • Ospedale Bianchi - Melacrino - Morelli
  • Ausl Di Rimini
  • Universita' Degli Studi Di Roma 'La Sapienza'
  • Casa sollievo della Sofferenza
  • A.O. Universitaria Senese
  • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino
  • Ospedale Ca Foncello
  • A.O.Cardinale Panico Ematologia e centro trapianti
  • A.O. Universitaria S. Maria Della Misericordia Di Udine
  • Ospedale Di Circolo E Fondazione Macchi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Experimental

Arm Label

GROUP 1 - STANDARD

GROUP 2

GROUP 1a

GROUP 1b

Arm Description

R-CHOP or R-bendamustine + Standard Maintenance

FDG-PET POSITIVE (score 4-5) patients (High risk) R-CHOP or R-bendamustine + Ibritumomab Tiuxetan + Maintenance

FDG-PET NEGATIVE (score 1-3) AND MRD NEGATIVE R-CHOP or R-bendamustine + Observation

FDG-PET NEGATIVE (score 1-3) AND MRD POSITIVE R-CHOP or R-bendamustine + Maintenance weekly x4

Outcomes

Primary Outcome Measures

PFS
To evaluate whether a FDG-PET and MRD response-based maintenance therapy is more effective in terms of Progression-Free Survival (PFS) than a standard maintenance therapy with Rituximab in patients with untreated, advanced, follicular lymphoma. Progression Free Survival (PFS) PFS will be measured from the date of randomization to the date of documented first occurrence of disease progression or relapse or to the date of death from any cause. Responding patients and patients who are lost to follow up will be censored at their last assessment date.

Secondary Outcome Measures

CRR
Complete Response Rate (CRR) is defined as the number of CR after the completion of the study treatment. Patients without a response assessment (due to any reasons) will be considered as non-responders.
ORR
Overall Response Rate (ORR) after the completion of the treatment, defined as the sum of Complete Response and Partial Response. Patients without a response assessment (due to any reasons) will be considered as non-responders.
DR
Duration of Response (DR) is from the time when criteria for response (ie, CR or PR) are met, to the first documentation of relapse or progression.
EFS
Event Free Survival (EFS) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death).
OS
Overall survival (OS) is defined as the time from the first day of study treatment until the date of death irrespective of cause. Patients who have not died at the time of end of the whole study , and patients who are lost to follow up , will be censored at the date of the last contact.
Molecular response analysis
Rate of molecular remission will be defined as the proportion of patients polymerase chain reaction (PCR) negative for Bcl2/IgH at different time-points including those achieving continuous MR in two or more consecutive time-points. Patients without a response assessment (due to any reasons) will be excluded from the analysis. Rate of conversion will be defined as the proportion of patients from baseline PCR-positivity to PCR-negativity. Patients without a response assessment (due to any reasons) will be excluded from the analysis. Rate of molecular relapse will be defined as the proportion of patients from PCR-negativity to PCR-positivity. Patients without a response assessment (due to any reasons) will be excluded from the analysis.

Full Information

First Posted
November 21, 2013
Last Updated
June 16, 2022
Sponsor
Fondazione Italiana Linfomi - ETS
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1. Study Identification

Unique Protocol Identification Number
NCT02063685
Brief Title
Study to Evaluate the Efficacy of Response-adapted Strategy in Follicular Lymphoma
Official Title
A Multicenter, Phase III, Randomized Study to Evaluate the Efficacy of Response-adapted Strategy to Define Maintenance After Standard Chemoimmunotherapy in Patients With Advanced-stage Follicular Lymphoma.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Recently, the availability of R has substantially changed therapeutic approach to FL patients, since its combination with chemotherapy has improved response rates, progression free survival (PFS) and overall survival (OS). Based on the results of recently completed randomized studies the standard treatment for patients with FL should consist of an initial therapy with R-CHOP combination followed by two-year maintenance with R. Although results of randomized trials confirmed that this approach results in an improved patients' outcome and made a step forward in the management of patients with FL, one important question that can be raised is if this approach is really needed for all patients with FL or if some of them could benefit from a reduced intensity treatment achieving the same results in terms of outcome and survival . This question is of particular interest for newly diagnosed patients for whom maintenance does not affect OS. More recent data demonstrated that the outcome of patients with FL can be further predicted by evaluating the quality of response to therapy studying minimal residual disease (MRD). This project addresses the objective of evaluating if combining clinical response assessed on FDG-PET scan and molecular response measured through MRD detection could permit to single out groups of patients at different risk of progression and to consequently modulate maintenance therapies, with the aim to provide clinicians a more rational use of the available diagnostic and therapeutic resources.
Detailed Description
This is a multicenter, randomized, phase III, superiority study comparing standard vs response driven approach to maintenance. Adult patients (age ≥ 18 years) with naïve, untreated follicular lymphoma, stage II-IV, Follicular Lymphoma International Prognostic Index 2 (FLIPI2) >0 requiring a therapeutic intervention will be recruited and randomly assigned in a 1:1 ratio to either standard or experimental arm. All patients will receive the same induction therapy with 6 cycles of R-CHOP or R-bendamustine and 2 additional doses of Rituximab. At baseline patients will be assessed for molecular status and staged by means of CT scan. A baselineFluorine-18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) scan should also be performed. At the end of chemoimmunotherapy all patients will be assessed for disease response by common clinical and laboratory examination, CT scan and FDG-PET. An intermediate assessment of response with CT scan and FDG-PET (optional) will also be performed after the first four courses of R-chemoimmunotherapy. At the end of induction therapy the status of minimal residual disease will be also evaluated. After induction treatment all responding patients in the standard arm will receive standard maintenance therapy with Rituximab (every 2 months for 2 years), while patients in the experimental arm will be subdivided into two risk groups and assigned to different post induction treatments based on FDG-PET and MRD results. In both arms, patients with stable or progressive disease (PET positive and less than PR on CT scan) will be addressed to salvage treatment chosen at physician discretion. In the experimental arm, risk group allocation will be performed primarily on the basis of FDG-PET results: Group 1 (low risk): negative FDG-PET Group 2 (high risk): positive FDG-PET Patients at low risk (FDG-PET negative) will received maintenance therapy according to their MRD status,particularly: Group 1a (MRD negative): observation Group 1b (MRD positive): pre-emptive Rituximab therapy Patient at high risk (FDG-PET positive) will receive maintenance regardless of their MRD status: · Group 2: intensified maintenance ((90)Y Ibritumomab Tiuxetan + Rituximab maintenance )

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
807 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP 1 - STANDARD
Arm Type
Other
Arm Description
R-CHOP or R-bendamustine + Standard Maintenance
Arm Title
GROUP 2
Arm Type
Experimental
Arm Description
FDG-PET POSITIVE (score 4-5) patients (High risk) R-CHOP or R-bendamustine + Ibritumomab Tiuxetan + Maintenance
Arm Title
GROUP 1a
Arm Type
Experimental
Arm Description
FDG-PET NEGATIVE (score 1-3) AND MRD NEGATIVE R-CHOP or R-bendamustine + Observation
Arm Title
GROUP 1b
Arm Type
Experimental
Arm Description
FDG-PET NEGATIVE (score 1-3) AND MRD POSITIVE R-CHOP or R-bendamustine + Maintenance weekly x4
Intervention Type
Drug
Intervention Name(s)
R-CHOP or R-bendamustine
Other Intervention Name(s)
Rituximab, Cyclophosphamide,, Hydroxydaunorubicin, Oncovin, Prednisone, Bendamustine
Intervention Description
As induction therapy all patients will receive 6 courses of: Rituximab: 375 mg/m² day 1 iv Cyclophosphamide: 750 mg/m² day 1 iv Doxorubicin: 50 mg/m² day 1 iv Vincristine: 1.4 mg/m² day 1 iv (max dose 2mg) Prednisone: 100 mg day 1-5 os To allow administration of all drugs on the same day, Rituximab rapid infusion is permitted starting from cycle 2. Cycles are to be repeated every 21 days. or 6 courses of: Rituximab: 375 mg/m² day 1 iv Bendamustine: 90 mg/m² day 1 and 2 iv. To allow administration of all drugs on the same day, Rituximab rapid infusion is permitted starting from cycle 2. Cycles are to be repeated every 28 days.
Intervention Type
Drug
Intervention Name(s)
Observation
Intervention Description
not maintenance therapy and followed-up with MRD monitoring.
Intervention Type
Drug
Intervention Name(s)
Maintenance weekly x4
Other Intervention Name(s)
Rituximab
Intervention Description
Four weekly doses of Rituximab (375 mg/m²). Rituximab could be repeated for MRD positive for a maximum of three courses
Intervention Type
Drug
Intervention Name(s)
Ibritumomab Tiuxetan + Maintenance
Other Intervention Name(s)
Ibritumomab Tiuxetan
Intervention Description
single dose of (90)Y Ibritumomab Tiuxetan (0.4 mCi/kg). Following RIT patients will continue maintenance with Rituximab (375 mg/m² every 2 months) for a total of 11 infusions.
Intervention Type
Drug
Intervention Name(s)
Standard Maintenance
Other Intervention Name(s)
Rituximab
Intervention Description
Rituximab 375 mg/m² every 2 months for 2 years. Maintenance will have to be started no more than 12 weeks after the last induction chemoimmunotherapy infusion.
Primary Outcome Measure Information:
Title
PFS
Description
To evaluate whether a FDG-PET and MRD response-based maintenance therapy is more effective in terms of Progression-Free Survival (PFS) than a standard maintenance therapy with Rituximab in patients with untreated, advanced, follicular lymphoma. Progression Free Survival (PFS) PFS will be measured from the date of randomization to the date of documented first occurrence of disease progression or relapse or to the date of death from any cause. Responding patients and patients who are lost to follow up will be censored at their last assessment date.
Time Frame
12/31/2019
Secondary Outcome Measure Information:
Title
CRR
Description
Complete Response Rate (CRR) is defined as the number of CR after the completion of the study treatment. Patients without a response assessment (due to any reasons) will be considered as non-responders.
Time Frame
12/31/2019
Title
ORR
Description
Overall Response Rate (ORR) after the completion of the treatment, defined as the sum of Complete Response and Partial Response. Patients without a response assessment (due to any reasons) will be considered as non-responders.
Time Frame
12/31/2019
Title
DR
Description
Duration of Response (DR) is from the time when criteria for response (ie, CR or PR) are met, to the first documentation of relapse or progression.
Time Frame
12/31/2019
Title
EFS
Description
Event Free Survival (EFS) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death).
Time Frame
12/31/2019
Title
OS
Description
Overall survival (OS) is defined as the time from the first day of study treatment until the date of death irrespective of cause. Patients who have not died at the time of end of the whole study , and patients who are lost to follow up , will be censored at the date of the last contact.
Time Frame
12/31/2019
Title
Molecular response analysis
Description
Rate of molecular remission will be defined as the proportion of patients polymerase chain reaction (PCR) negative for Bcl2/IgH at different time-points including those achieving continuous MR in two or more consecutive time-points. Patients without a response assessment (due to any reasons) will be excluded from the analysis. Rate of conversion will be defined as the proportion of patients from baseline PCR-positivity to PCR-negativity. Patients without a response assessment (due to any reasons) will be excluded from the analysis. Rate of molecular relapse will be defined as the proportion of patients from PCR-negativity to PCR-positivity. Patients without a response assessment (due to any reasons) will be excluded from the analysis.
Time Frame
12/31/2019

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Histological diagnosis of B-Cell CD20+ Follicular Lymphoma (FL), grade I, II, IIIa according to the WHO 2008 classification ECOG performance status 0-2 Age ≥ 18 years Ann Arbor stage II-IV FLIPI2>0 Presence of evaluable/measurable disease after diagnostic biopsy At least one of the following criteria for defining active disease: systemic symptoms cytopenia due to bone marrow involvement LDH> upper normal value any nodal or extranodal tumor mass with a diameter >7cm involvement of ≥ 3 nodal sites, each with a diameter of ≥ 3cm extranodal disease rapidly progressive disease Life expectancy > 6 months Left ventricular ejection fraction (LVEF) ³ 50% Serum negativity for HIV Serum negativity for HBsAg; HBcAb positive but HBV-DNA negative patients are allowed with mandatory Lamivudine prophylaxis. Serum negativity for HCV, except for those patients without signs of active viral replication assessed by HCV-RNA copies Serum creatinine < 2mg/dl , serum bilirubin < 1.5mg/dl, aspartate amino-transferase (AST/GOT) £ 2.5xUNV, alanine amino-transferase (ALT/GPT) £ 2.5xUNV, and alkaline phosphatase £ 4 times the upper limit of normal (unless the increase is attributed directly to the presence of tumour by the Investigator) Patients with no previous treatment for the lymphoma with the exception of locoregional radiotherapy (IFRT) Adequate measure adoption to avoid pregnancy Written informed consent given at time of registration Patient must be accessible for treatment and follow up. Exclusion Criteria: Histological diagnosis of : any lymphoma other than follicular lymphoma and all CD20 negative B-cell lymphomas grade III b follicular lymphoma evidence of transformation to high grade lymphoma Ann Arbor stage I Suspect or clinical evidence of CNS involvement by lymphoma History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer, low grade, early stage localized prostate cancer treated surgically with curative intent, good prognosis DCIS of the breast treated with lumpectomy alone with curative intent Evidence of any severe active acute or chronic infection Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy Severe chronic obstructive pulmonary disease with hypoxemia Severe diabetes mellitus difficult to control with adequate insulin therapy Myocardial infarction within 6 months before study entry Clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension, (resting diastolic blood pressure >115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV HbsAg-positive, HIV-positive, or HCVAb-positive patients Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent Follicular lymphoma, showing a negative baseline PET scan.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donato Mannina, MD
Organizational Affiliation
Hematology, Azienda Ospedali Riuniti Papardo-Piemonte, Messina, Italy.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Massimo Federico, MD
Organizational Affiliation
Department of Diagnostic Medicine, Clinical Medicine and Public Health, University of Modena and Reggio Emilia, Modena , Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Sede Di Meldola (Fc)
City
Meldola
State/Province
Forlì Cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
ASUR 8
City
Civitanova Marche
State/Province
Macerata
ZIP/Postal Code
62012
Country
Italy
Facility Name
Irccs Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione IRCCS Milano INT
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliera S. Gerardo Di Monza
City
Monza
State/Province
Monza Brianza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
City
Rionero in Vulture
State/Province
Potenza
ZIP/Postal Code
85028
Country
Italy
Facility Name
P.O. Umberto I
City
Nocera Inferiore
State/Province
Salerno
ZIP/Postal Code
84014
Country
Italy
Facility Name
Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
A.O. S. Maria di Terni
City
Terni
State/Province
TR
ZIP/Postal Code
05100
Country
Italy
Facility Name
Ospedale Civile Ss. Antonio E Biagio Di Alessandria - Alessandria (Al)
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
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
A.O. Ospedale Degli Infermi
City
Biella
ZIP/Postal Code
13900
Country
Italy
Facility Name
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Pres.Ospedal.Spedali Civili Brescia
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Facility Name
Stabilimento "Perrino" - Brindisi -
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
Ospedale Armando Businco - Cagliari
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
Facility Name
A.O. Universitaria Ospedale Vittorio Emanuele Di Catania
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Azienda Ospedaliera S. Croce E Carle Di Cuneo
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
A.O. Universitaria Careggi Di Firenze
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
A.O. Universitaria S. Martino Di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ematologia Ospedale Vito Fazzi
City
Lecce
Country
Italy
Facility Name
Presidio Ospedaliero - Matera -
City
Matera
ZIP/Postal Code
75100
Country
Italy
Facility Name
Azienda Ospedaliera Papardo
City
Messina
ZIP/Postal Code
98158
Country
Italy
Facility Name
Irccs Ospedale Maggiore Policlinico Di Milano
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale Ca' Granda-Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
A.O. Universitaria Policlinico Di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Irccs Istituto Nazionale Tumori Fondazione Pascale
City
Napoli
Country
Italy
Facility Name
A.O. Universitaria Maggiore Della Carita' Di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Ospedale San Francesco
City
Nuoro
ZIP/Postal Code
08100
Country
Italy
Facility Name
A.O. Universitaria Policlinico Giaccone Di Palermo
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
A.O. "V. Cervello"
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
A O Universitaria di Parma
City
Parma
Country
Italy
Facility Name
IRCCS Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera Di Perugia - Ospedale S. Maria Della Misericordia -
City
Perugia
ZIP/Postal Code
06134
Country
Italy
Facility Name
Ospedale Civile Spirito Santo
City
Pescara
ZIP/Postal Code
65124
Country
Italy
Facility Name
Ausl Di Piacenza
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Facility Name
A.O. Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ospedale Bianchi - Melacrino - Morelli
City
Reggio Calabria
ZIP/Postal Code
89123
Country
Italy
Facility Name
Ausl Di Rimini
City
Rimini
ZIP/Postal Code
47924
Country
Italy
Facility Name
Universita' Degli Studi Di Roma 'La Sapienza'
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
Casa sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
A.O. Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Ca Foncello
City
Treviso
Country
Italy
Facility Name
A.O.Cardinale Panico Ematologia e centro trapianti
City
Tricase (LE)
Country
Italy
Facility Name
A.O. Universitaria S. Maria Della Misericordia Di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Ospedale Di Circolo E Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
34709880
Citation
Luminari S, Manni M, Galimberti S, Versari A, Tucci A, Boccomini C, Farina L, Olivieri J, Marcheselli L, Guerra L, Ferrero S, Arcaini L, Cavallo F, Kovalchuk S, Skrypets T, Del Giudice I, Chauvie S, Patti C, Stelitano C, Ricci F, Pinto A, Margiotta Casaluci G, Zilioli VR, Merli A, Ladetto M, Bolis S, Pavone V, Chiarenza A, Arcari A, Anastasia A, Dondi A, Mannina D, Federico M; Fondazione Italiana Linfomi. Response-Adapted Postinduction Strategy in Patients With Advanced-Stage Follicular Lymphoma: The FOLL12 Study. J Clin Oncol. 2022 Mar 1;40(7):729-739. doi: 10.1200/JCO.21.01234. Epub 2021 Oct 28.
Results Reference
derived

Learn more about this trial

Study to Evaluate the Efficacy of Response-adapted Strategy in Follicular Lymphoma

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