A Phase 3 interventional study of Radiotherapy and Radiotherapy plus Obinutuzumab in Follicular Lymphoma, sponsored by Fondazione Italiana Linfomi - ETS. Recruiting at 49 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Fondazione Italiana Linfomi - ETS · Phase 3, Interventional, and Treatment
Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage. Patients will be randomized to receive Radiotherapy or Radiotherapy plus Obinutuzumab.
Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage (I-II non-bulky).
Patients will be randomized to receive:
- Involved-Site Radiation Therapy at standard dose 24Gy - standard arm
OR
- Involved-Site Radiation Therapy at standard dose 24Gy followed by Obinutuzumab 4 infusions weekly + 4 infusions every 3 weeks (8 total doses) - experimental arm
1,891 studies on the registry are indexed under Lymphoma, Follicular; 290 are open to participants now.
This study's planned enrollment of 190 is above the median of 48 across 1,503 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →Fondazione Italiana Linfomi - ETS is the lead sponsor of 91 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate renal function defined as follows:
Adequate hepatic function per local laboratory reference range as follows:
Fertility and pregnancy prevention criteria
Women must be:
Male even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of the following
Exclusion Criteria:
Evidence of other uncontrolled condition(s) including, but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiotherapy alone
Radiation: Radiotherapy
Radiotherapy plus Obinutuzumab
Other: Radiotherapy plus Obinutuzumab
Involved-Site Radiation Therapy 24Gy
Involved-Site Radiation Therapy 24Gy followed by Obinutuzumab 1000mg flat dose 4 doses weekly plus addition 4 doses every 3 weeks
Progression-free survival (PFS)
Time between the randomization to first documentation of recurrence, progression or death from any cause at 2 years
Time frame: From treatment start up to 33 months (9 months treatment period and 24 months of follow-up)
Complete response rate (CRR)
Complete response (CR) rate according to the international criteria (Cheson 2014)
Time frame: From therapy start up to end of treatment (9 months)
Overall response rate (ORR)
ORR will be defined as the proportion of patients who have a partial or complete response at every treatment phase
Time frame: From therapy start up to end of treatment (9 months)
Disease Free Survival (DFS)
Time between the first documentation of Complete Response to any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of a new treatment without documented progression) or death from any cause
Time frame: From post radiotherapy assessment up to 45 months (9 months treatment phase plus 36 months of follow-up)
Event Free Survival (EFS)
Time between the randomization to any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of a new treatment without documented progression) or death from any cause
Time frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Number of patients with Molecular Response at end of treatment
MRD negativity at end of treatment for positive patients at baseline
Time frame: From therapy start up to end of treatment (9 months)
Rate of Adverse Events
Incidence and severity of AEs in both arms according to latest CTCAE criteria
Time frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Prognostic and predictive impact of presence/abscence of t(14;18) rearrangement measured by FISH
Prognostic and predictive impact on PFS in presence or absence of t(14;18) rearrangement measured by FISH
Time frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Prognostic role of Minimal Residual Disease by conventional (BCL2/IGH rearrangement by ddPCR) and ctDNA method
Prognostic role of conventional MRD (BCL2/IGH rearrangement by ddPCR) and of MRD on plasmatic circulating tumour deoxyribonucleic acid (ctDNA) at different time points for PFS and relapse
Time frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Prognostic and predictive value of different threshold of metabolic response expressed as SUVmax, MTV and TLG at baseline (PET-0);
Prognostic and predictive value of different threshold of metabolic response expressed as quantitative PET indexes (QPI) at baseline (PET-0), i.e. SUVmax, MTV and TLG;
Time frame: At baseline (before therapy start)
Prognostic and predictive role of liquid biopsy by DNA sequencing for lymphoma mutations
Prognostic and predictive role of liquid biopsy by DNA sequencing for lymphoma mutations at different time points on PFS and relapse
Time frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Prognostic and predictive value of radiological markers assessed by Machine Learning tools (pyRadiomics)
Prognostic and predictive value of radiomic analysis on PFS, assessed on both CT and PET scans by Machine Learning tools (pyRadiomics);
Time frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Correlation of MRD results with the radiomics results and clinical outcomes
Correlation of MRD results with the radiomics results and clinical outcomes
Time frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Comparison between genotype at diagnosis and at relapse assessed by RNA sequencing (CIBERSORTx)
Comparison between genotype at diagnosis and at relapse assessed by RNA sequencing (CIBERSORTx)
Time frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
Evaluation of liquid biopsy as a tool to identity specific mutations predictive for clonal evolution of lymphoma
Evaluation of liquid biopsy as a tool to identity specific mutations predictive for clonal evolution of lymphoma
Time frame: From therapy start up to 45 months (9 months treatment phase plus 36 months of follow-up)
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Fondazione Italiana Linfomi - ETS