Diffuse Large B Cell Non-Hodgkin LymphomaPhase 2FIL_RICCONCT06835530
A Combination of Rituximab and CC-99282 as Front-line Therapy for Older Frail Patients With Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated With a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL)
A Phase 2 study testing Rituximab + Golcadomide (CC-99282) in people with Diffuse Large B Cell Non-Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 20 sites in Italy.
Trial summary
Prospective, multicenter, single arm, phase II study, to evaluate the efficacy of the combination rituximab-golcadomide as a chemo free approach in a population of older patients with new diagnosis of DLBCL, defined as frail according to a sGA evaluation and not candidate for the standard R-CHOP (or R-CHOP like)… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Diffuse Large B Cell Non-Hodgkin Lymphoma
- What is being tested?
- Rituximab + Golcadomide (CC-99282)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 20 sitesItaly
- Study dates
- 9 Apr 2025to Apr 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Able to provide written informed consent form approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study- specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.
- Histologically documented diagnosis of DLBCL as defined in the 5th edition of the World Health Organization (WHO) classification (2022)
- Previously untreated
- Frail patients defined as follows (Appendix A-D): Age ≥ 80 years: activity of daily living (ADL) < 6 residual functions and/or Instrumental activity of daily living (IADL) < 8 residual functions and/or cumulative illness rating scale (CIRS) > 5 comorbidities of grade 2 and/or one or more comorbidities of grade 3-4
- Patient not eligible to anthracycline-based chemotherapy
- Ann Arbor Stage I - IV (Appendix E)
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- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3 (Appendix F)
- At least one site of measurable nodal disease at baseline [≥ 1.5 cm] in the longest transverse diameter as determined by CT scan
- Adequate hematological counts defined as follows:
- WBC > 2.5 x 109/L with ANC > 1.0 x 109/L unless due to bone marrow involvement by lymphoma
- Platelet count ≥ 75 x 109/L unless due to bone marrow involvement by lymphoma
- Hemoglobin ≥ 10 g/dL unless anemia related to active lymphoma
- Adequate renal function defined as creatinine clearance ≥ 30 mL/min (Appendix G). The same CrCl cutoff applies in case of documented renal involvement by lymphoma
- Adequate hepatic function per local laboratory reference range, unless secondary to lymphoma, as follows:
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 x ULN
- Bilirubin ≤ 2 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, i.e. mild and chronic hemolysis)
- Subject must be able to adhere to the study visit schedule and other protocol requirements
- Subject must be able to swallow capsules or tablets
- Life expectancy ≥ 3 months
- Male subjects must practice complete abstinence when this is in line with the usual lifestyle (periodic abstinence is not permitted) or agree to use specified contraceptive methods (barrier contraception: condom) during sexual contact with a female of childbearing potential while participating in the study, for at least 28 days following investigational product discontinuation, even if he has undergone a successful vasectomy. Furthermore, they do not have to donate sperm during the study and for at least 28 days after receiving the last dose of study drug. If applicable, male subjects must receive study specific Pregnancy Prevention Plan (PPP).
Who cannot join
- Histological diagnosis different from DLBCL
- Central nervous system (CNS) involvement with lymphoma
- Severe heart failure (NYHA grado III-IV and/or LVEF < 45%), liver disease Child Pugh C, history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, or pulse oximetry of < 92% while breathing room air, or any other clinical condition that would preclude participation in the study or compromise ability to give informed consent
- Any history of other active malignancies within 5 years prior to study entry, except for adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent
- Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy) or any other malabsorption condition
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
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- Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2
- Chronic or acute hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV i.e. hepatitis B surface (HBs) antigen (Ag) negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative, may participate; patients with positive anti-HBc antibody from previous infection or inactive carriers are eligible only with HBV-DNA negative and with concomitant treatment with Lamivudine or Tenofovir
- Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA
- Human immunodeficiency virus (HIV) seropositivity
- Absence of caregivers in non-autonomous patients
- Allergy or intolerance to the active or inactive ingredients of study drugs
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
Italy20 sites, 20 recruiting
- Recruiting
AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria - SCDU Ematologia
Alessandria, Alessandria, 15121
Manuela Zanni, Dr., +390131206156, manuela.zanni@ospedale.al.it
Manuela Zanni, Dr.
- Recruiting
AOU Ospedali Riuniti - Clinica di Ematologia
Ancona
Guido Gini, Dr., +390715964562, guido.gini@ospedaliriuniti.marche.it
Guido Gini, Dr.
- Recruiting
Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e trapianto emopoietico
Avellino
Sonya De Lorenzo, Dr., +390825203281, sonya.delorenzo@tin.it
Sonya De Lorenzo, Dr.
- Recruiting
Ospedale IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuno-correlati
Aviano
Michele Spina, Dr., +390434659730, mspina@cro.it
Michele Spina, Dr.
- Recruiting
ASST Spedali Civili di Brescia - Ematologia
Brescia
Alessandra Tucci, Dr., +390303995438, alessandra.tucci@asst-spedalicivili.it
Alessandra Tucci, Dr.
- Recruiting
Azienda Ospedaliera Universitaria Careggi -Unità Funzionale di Ematologia
Florence
Benedetta Puccini, Dr., +390557945296, puccinib@aou-careggi.toscana.it
Benedetta Puccini, Dr.
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan
Vittorio Zilioli, Dr., +393494921317, vittorioruggero.zilioli@ospedaleniguarda.it
Vittorio Zilioli, Dr.
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori -Ematologia
Monza
Ivana Casaroli, Dr., +393396804439, ivanarita.casaroli@irccs-sangerardo.it
Ivana Casaroli, Dr.
- Recruiting
I.R.C.C.S. Istituto Oncologico Veneto -Oncologia 1
Padova
Dario Marino, Dr., +393396804439, ivanarita.casaroli@irccs-sangerardo.it
Dario Marino, Dr.
- Not yet recruiting
Policlinico Giaccone - Ematologia
Palermo
Salvatrice Mancuso, Dr., +390916554505, salvatrice.mancuso@unipa.it
Salvatrice Mancuso, Dr.
- Not yet recruiting
Azienda Sanitaria Locale di Pescara- Presidio Ospedaliero Santo Spirito - U.O.C. Ematologia
Pescara, Pescara, 65128
Elsa Pennese, MD, +390854252838, elsa.pennese@asl.pe.it
Elsa Pennese, MD
- Recruiting
Azienda USL Piacenza - UOC Ematologia e Centro Trapianti,
Piacenza
Annalisa Arcari, Dr., +390523303724, a.arcari@ausl.pc.it
Annalisa Arcari, Dr.
- Recruiting
Ospedale delle Croci - Ematologia
Ravenna
Monica Tani, Dr., +390544285330, monica.tani@auslromagna.it
Monica Tani, Dr.
- Recruiting
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia
Maria Elena Nizzoli, Dr., +390522296623, mariaelena.nizzoli@ausl.re.it
Maria Elena Nizzoli, Dr.
- Recruiting
Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapie Cellulari, Policlinico Universitario Campus Bio-Medico
Roma
Luigi Rigacci, Dr., +3906225411129, l.rigacci@policlinicocampus.it
Luigi Rigacci, Dr.
- Recruiting
AOU Senese - U.O.C. Ematologia
Siena
Alberto Fabbri, Dr., +390577586798, fabbri7@unisi.it
Alberto Fabbri, Dr.
- Recruiting
A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria
Torino
Federica Cavallo, Dr., +390116334264, f.cavallo@unito.it
Federica Cavallo, Dr.
- Recruiting
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Torino
Mattia Novo, Dr., +390116334553, mnovo@cittadellasalute.to.it
Mattia Novo, Dr.
- Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - S.C. Ematologia
Trieste
Elisa Lucchini, Dr., +390403992677, elisa.lucchini@asugi.sanita.fvg.it
Elisa Lucchini, Dr.
- Recruiting
AOU Integrata di Verona - U.O. Ematologia
Verona
Cinzia Sissa, Dr., +390458126634, cinzia.sissa@aovr.veneto.it
Cinzia Sissa, Dr.
About this study
Prospective, multicenter, single arm, phase II study, to evaluate the efficacy of the combination rituximab-golcadomide as a chemo free approach in a population of older patients with new diagnosis of DLBCL, defined as frail according to a sGA evaluation and not candidate for the standard R-CHOP (or R-CHOP like) treatments.
Read the detailed description
This is a prospective, multicenter, phase II study, in older patients affected by DLBCL defined as frail according to sGA and previously untreated.
All patients will receive an induction phase with a combination of golcadomide, rituximab and only at cycle 1 dexamethasone, for a maximum number of 6 cycles of 28 days.
Response assessment is planned after 4 and after 6 cycles for identification of non-responding patients. Patients achieving at least a PR at the interim restaging and after 6th cycle will complete therapy as planned, while patients with stable and progressive disease will discontinue protocol treatment and will be addressed to an alternative regimen.
At the end of the 6th cycle of induction (EOI), involved site radiotherapy is allowed on PET positive sites.
At EOI (end of induction), if the patient reached at least a partial response (≥PR), a consolidation phase was planned with golcadomide, for a maximum of 6 cycles of 28 days.
During consolidation phase, an interim check for response will be performed after the completion of 3 cycles in order to early identify progressive disease. Patients with progressive disease will stop protocol treatment and will be treated at physician discretion.
End of treatment response will be evaluated within 4-6 weeks after the last cycle of consolidation (or the last study medication administration).
All patients will be monitored during follow up for 24 months, every 3 months for the first year and every 6 months for the second year.
Patients experimenting progression at any time will be considered as treatment failures and will be followed-up for survival until the end of the study.
Baseline and EOT 18FDG PET/CT or CT scan including pre-contrast phase (only if PET/CT is not performed) will be evaluated for sarcopenia assessment.
Quality of life (QoL) evaluation is planned at study entry and at established timepoints during and after treatment and follow-up.
- Being tested
- Rituximab + Golcadomide (CC-99282)
- Keywords
- diffuse large B-cell non-Hodgkin lymphoma, simplified geriatric assessment (sGA), rituximab, older frail patients, Golcadomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab + Golcadomide (CC-99282)Drug
A combination of Rituximab and CC-99282 as front-line therapy for older frail patients with Diffuse Large B-cells non-Hodgkin Lymphoma evaluated with a simplified Geriatric Assessment (sGA).
| Study group | Role | What they receive |
|---|---|---|
| Rituximab in combination with Golcadomide (CC-99282) | Experimental | Induction Phase (6 cycles every 28 days): Cycle 1 (Rituximab 375 mg/mq i.v. on days 1, 8, 15; Golcadomide 0,3 mg/day p.o. days 1-14; Dexamethasone 5 mg p.o. on days 1, 8, 15, 22). Cycles 2-6 (Rituximab 375 mg/mq i.v. on day 1; Golcadomide 0,4 mg/day p.o. days 1-14).
Consolidation phase (for patients achieving at least a partial response at the end of induction (≥PR), the consolidation phase will start within 6-8 weeks from Cycle 6 Day1 and will be continued up to 6 cycles every 28 days): golcadomide 0.2 mg / day p.o. days 1-14.
Consolidation radiotherapy: involved site radiotherapy (ISR) is allowed at the end of induction phase on PET positive sites, according to the available guidelines (Illidge et al., 2014). ISR should be concomitant to consolidation phase. Receives: Drug: Rituximab + Golcadomide (CC-99282) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) at 24 months
PFS defined as the time between the start of prephase and the first documentation of recurrence, progression or death from any cause.
Measured: from enrollment to 24 month
Secondary outcomes (9)
ORR Overall response rate (partial response, PR + complete response, CR) and CR after the 4th and 6th cycle
ORR Overall response rate (partial response, PR + complete response, CR) and CR after the 4th and 6th cycle
Measured: From the start of treatment to approximately 4 months and 6 months
Overall survival (OS)
OS defined as the time between the start of prephase and death from any cause
Measured: from enrollment to 60 month
Rate of treatment discontinuation due to AE or treatment intolerance
Rate of treatment discontinuation due to AE or treatment intolerance
Measured: From the start of treatment to 60 months
QoL (quality of life) scores at baseline - EORTC-QLQ-C30
Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30) questionnaire
Measured: The endpoint wil be evaluated at the baseline
QoL (quality of life) scores variations at 6 months - EORTC-QLQ-C30
Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30) questionnaire
Measured: The endpoint will be evaluated from the beginning of the study to 6 months
QoL (quality of life) scores variations at 12 months - EORTC-QLQ-C30
Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30) questionnaire
Measured: The endpoint will be evaluated from the beginning of the study to 12 months
QoL (quality of life) scores at baseline - FACT-Lym-LymS
Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms)
Measured: The endpoint wil be evaluated at the baseline
QoL (quality of life) scores variations at 6 months - FACT-Lym-LymS
Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire)
Measured: The endpoint will be evaluated from the beginning of the study to 6 months
QoL (quality of life) scores variations after 12 months - FACT-Lym-LymS
Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms)
Measured: The endpoint will be evaluated from the beginning of the study to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start9 Apr 2025
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandra Tucci, Dr.ssa, Principal investigator, UO Ematologia, ASST Spedali Civili di Brescia, Piazzale Spedali Civili, 1, 25123 Brescia, Italia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835530
- Sponsor's protocol ID
- FIL_RICCO
- Other IDs
- 2023-506206-38-00, 2023
- Acronym
- FIL_RICCO
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of Rituximab and CC-99282 as Front-line Therapy for Older Frail Patients With Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated With a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL)
- ClinicalTrials.gov ID
- NCT06835530
- Acronym / sponsor ID
- FIL_RICCO / FIL_RICCO
- Keywords
- diffuse large B-cell non-Hodgkin lymphoma, simplified geriatric assessment (sGA), rituximab, older frail patients, Golcadomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, single arm, phase II study, to evaluate the efficacy of the combination rituximab-golcadomide as a chemo free approach in a population of older patients with new diagnosis of DLBCL, defined as frail according to a sGA evaluation and not candidate for the standard R-CHOP (or R-CHOP like) treatments.
Detailed description
This is a prospective, multicenter, phase II study, in older patients affected by DLBCL defined as frail according to sGA and previously untreated.
All patients will receive an induction phase with a combination of golcadomide, rituximab and only at cycle 1 dexamethasone, for a maximum number of 6 cycles of 28 days.
Response assessment is planned after 4 and after 6 cycles for identification of non-responding patients. Patients achieving at least a PR at the interim restaging and after 6th cycle will complete therapy as planned, while patients with stable and progressive disease will discontinue protocol treatment and will be addressed to an alternative regimen.
At the end of the 6th cycle of induction (EOI), involved site radiotherapy is allowed on PET positive sites.
At EOI (end of induction), if the patient reached at least a partial response (≥PR), a consolidation phase was planned with golcadomide, for a maximum of 6 cycles of 28 days.
During consolidation phase, an interim check for response will be performed after the completion of 3 cycles in order to early identify progressive disease. Patients with progressive disease will stop protocol treatment and will be treated at physician discretion.
End of treatment response will be evaluated within 4-6 weeks after the last cycle of consolidation (or the last study medication administration).
All patients will be monitored during follow up for 24 months, every 3 months for the first year and every 6 months for the second year.
Patients experimenting progression at any time will be considered as treatment failures and will be followed-up for survival until the end of the study.
Baseline and EOT 18FDG PET/CT or CT scan including pre-contrast phase (only if PET/CT is not performed) will be evaluated for sarcopenia assessment.
Quality of life (QoL) evaluation is planned at study entry and at established timepoints during and after treatment and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab in combination with Golcadomide (CC-99282) | Experimental | Drug: Rituximab + Golcadomide (CC-99282)Induction Phase (6 cycles every 28 days): Cycle 1 (Rituximab 375 mg/mq i.v. on days 1, 8, 15; Golcadomide 0,3 mg/day p.o. days 1-14; Dexamethasone 5 mg p.o. on days 1, 8, 15, 22). Cycles 2-6 (Rituximab 375 mg/mq i.v. on day 1; Golcadomide 0,4 mg/day p.o. days 1-14). Consolidation phase (for patients achieving at least a partial response at the end of induction (≥PR), the consolidation phase will start within 6-8 weeks from Cycle 6 Day1 and will be continued up to 6 cycles every 28 days): golcadomide 0.2 mg / day p.o. days 1-14. Consolidation radiotherapy: involved site radiotherapy (ISR) is allowed at the end of induction phase on PET positive sites, according to the available guidelines (Illidge et al., 2014). ISR should be concomitant to consolidation phase. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (20 listed)
- Able to provide written informed consent form approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study- specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.
- Histologically documented diagnosis of DLBCL as defined in the 5th edition of the World Health Organization (WHO) classification (2022)
- Previously untreated
- Frail patients defined as follows (Appendix A-D): Age ≥ 80 years: activity of daily living (ADL) < 6 residual functions and/or Instrumental activity of daily living (IADL) < 8 residual functions and/or cumulative illness rating scale (CIRS) > 5 comorbidities of grade 2 and/or one or more comorbidities of grade 3-4
- Patient not eligible to anthracycline-based chemotherapy
Key exclusion criteria (12 listed)
- Histological diagnosis different from DLBCL
- Central nervous system (CNS) involvement with lymphoma
- Severe heart failure (NYHA grado III-IV and/or LVEF < 45%), liver disease Child Pugh C, history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, or pulse oximetry of < 92% while breathing room air, or any other clinical condition that would preclude participation in the study or compromise ability to give informed consent
- Any history of other active malignancies within 5 years prior to study entry, except for adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent
- Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy) or any other malabsorption condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab + Golcadomide (CC-99282)A combination of Rituximab and CC-99282 as front-line therapy for older frail patients with Diffuse Large B-cells non-Hodgkin Lymphoma evaluated with a simplified Geriatric Assessment (sGA). | Drug | Rituximab in combination with Golcadomide (CC-99282) |
Primary outcome
Progression free survival (PFS) at 24 months
Time frame: from enrollment to 24 month
PFS defined as the time between the start of prephase and the first documentation of recurrence, progression or death from any cause.
9 secondary outcomes
ORR Overall response rate (partial response, PR + complete response, CR) and CR after the 4th and 6th cycle
Time frame: From the start of treatment to approximately 4 months and 6 months
Overall survival (OS)
Time frame: from enrollment to 60 month
Rate of treatment discontinuation due to AE or treatment intolerance
Time frame: From the start of treatment to 60 months
QoL (quality of life) scores at baseline - EORTC-QLQ-C30
Time frame: The endpoint wil be evaluated at the baseline
QoL (quality of life) scores variations at 6 months - EORTC-QLQ-C30
Time frame: The endpoint will be evaluated from the beginning of the study to 6 months
QoL (quality of life) scores variations at 12 months - EORTC-QLQ-C30
Time frame: The endpoint will be evaluated from the beginning of the study to 12 months
QoL (quality of life) scores at baseline - FACT-Lym-LymS
Time frame: The endpoint wil be evaluated at the baseline
QoL (quality of life) scores variations at 6 months - FACT-Lym-LymS
Time frame: The endpoint will be evaluated from the beginning of the study to 6 months
QoL (quality of life) scores variations after 12 months - FACT-Lym-LymS
Time frame: The endpoint will be evaluated from the beginning of the study to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandra Tucci, Dr.ssa principal investigator
UO Ematologia, ASST Spedali Civili di Brescia, Piazzale Spedali Civili, 1, 25123 Brescia, Italia
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab + Golcadomide (CC-99282) in people with Diffuse Large B Cell Non-Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) at 24 months (time frame: from enrollment to 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.