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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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 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) (NCT06835530) is a Phase 2 interventional studying Diffuse Large B Cell Non-Hodgkin Lymphoma, sponsored by Fondazione Italiana Linfomi - ETS. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Diffuse Large B Cell Non-Hodgkin Lymphoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 47 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able to provide written willing to sign a consent form 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. 2. Histologically documented diagnosis of DLBCL as defined in the 5th edition of the World Health Organization (WHO) classification (2022) 3. Previously untreated 4. 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 5. Patient not eligible to anthracycline-based chemotherapy 6. Ann Arbor Stage I - IV (Appendix E) 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3 (Appendix F) 8. At least one site of measurable nodal disease at baseline \[≥ 1.5 cm\] in the longest transverse diameter as determined by CT scan 9. 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 - blood count (hemoglobin) at least 10 g/dL unless anemia related to active lymphoma 10. Adequate renal function defined as kidney function (creatinine clearance) at least 30 mL/min (Appendix G). The same CrCl cutoff applies in case of documented renal involvement by lymphoma 11. 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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. 2. Histologically documented diagnosis of DLBCL as defined in the 5th edition of the World Health Organization (WHO) classification (2022) 3. Previously untreated 4. 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 5. Patient not eligible to anthracycline-based chemotherapy 6. Ann Arbor Stage I - IV (Appendix E) 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3 (Appendix F) 8. At least one site of measurable nodal disease at baseline \[≥ 1.5 cm\] in the longest transverse diameter as determined by CT scan 9. 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 10. 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 11. 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) 12. Subject must be able to adhere to the study visit schedule and other protocol requirements 13. Subject must be able to swallow capsules or tablets 14. Life expectancy ≥ 3 months 15. 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). Exclusion Criteria: 1. Histological diagnosis different from DLBCL 2. Central nervous system (CNS) involvement with lymphoma 3. 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 4. 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 5. Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy) or any other malabsorption condition 6. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: 1. Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2 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 3. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA 7. Human immunodeficiency virus (HIV) seropositivity 8. Absence of caregivers in non-autonomous patients 9. Allergy or intolerance to the active or inactive ingredients of study drugs

Treatments Being Tested

DRUG

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).

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria - SCDU Ematologia
Alessandria, Italy
AOU Ospedali Riuniti - Clinica di Ematologia
Ancona, Italy
Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e trapianto emopoietico
Avellino, Italy
Ospedale IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuno-correlati
Aviano, Italy
ASST Spedali Civili di Brescia - Ematologia
Brescia, Italy
Azienda Ospedaliera Universitaria Careggi -Unità Funzionale di Ematologia
Florence, Italy
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori -Ematologia
Monza, Italy
I.R.C.C.S. Istituto Oncologico Veneto -Oncologia 1
Padova, Italy
Policlinico Giaccone - Ematologia
Palermo, Italy
Azienda Sanitaria Locale di Pescara- Presidio Ospedaliero Santo Spirito - U.O.C. Ematologia
Pescara, Italy
Azienda USL Piacenza - UOC Ematologia e Centro Trapianti,
Piacenza, Italy
Ospedale delle Croci - Ematologia
Ravenna, Italy
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia, Italy
Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapie Cellulari, Policlinico Universitario Campus Bio-Medico
Roma, Italy
AOU Senese - U.O.C. Ematologia
Siena, Italy
A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, Italy
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Torino, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - S.C. Ematologia
Trieste, Italy
AOU Integrata di Verona - U.O. Ematologia
Verona, Italy

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06835530), the sponsor (Fondazione Italiana Linfomi - ETS), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06835530 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06835530?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06835530?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06835530. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06835530. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.