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New hope for frail elderly lymphoma patients: Chemo-Free combo trial launches

NCT ID NCT06835530

Disease control Sponsor: Fondazione Italiana Linfomi - ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This phase 2 trial is testing a combination of two drugs, rituximab and golcadomide, as a first treatment for older frail patients with diffuse large B-cell lymphoma who cannot have standard chemotherapy. The study aims to see if this chemo-free approach can control the cancer and improve survival. About 47 participants will be enrolled across multiple centers in Italy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rituximab and golcadomide (CC-99282)
What this could lead to
If this works, it could offer a gentler, chemo-free treatment option for older frail patients with diffuse large B-cell lymphoma who cannot tolerate standard chemotherapy.
What could go wrong
This is a small, early-phase (phase 2) study with only 47 participants, so results may not apply broadly. The combination may still cause side effects or fail to control the disease long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 47 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

80 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B cell non-Hodgkin lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria

    RECRUITING

    Torino, Italy

  • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia

    RECRUITING

    Torino, Italy

  • AOU Integrata di Verona - U.O. Ematologia

    RECRUITING

    Verona, Italy

  • AOU Ospedali Riuniti - Clinica di Ematologia

    RECRUITING

    Ancona, Italy

  • AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria - SCDU Ematologia

    RECRUITING

    Alessandria, Alessandria, 15121, Italy

  • AOU Senese - U.O.C. Ematologia

    RECRUITING

    Siena, Italy

  • ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

    RECRUITING

    Milan, Italy

  • ASST Spedali Civili di Brescia - Ematologia

    RECRUITING

    Brescia, Italy

  • Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e trapianto emopoietico

    RECRUITING

    Avellino, Italy

  • Azienda Ospedaliera Universitaria Careggi -Unità Funzionale di Ematologia

    RECRUITING

    Florence, Italy

  • Azienda Sanitaria Locale di Pescara- Presidio Ospedaliero Santo Spirito - U.O.C. Ematologia

    NOT_YET_RECRUITING

    Pescara, Pescara, 65128, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - S.C. Ematologia

    RECRUITING

    Trieste, Italy

  • Azienda USL Piacenza - UOC Ematologia e Centro Trapianti,

    RECRUITING

    Piacenza, Italy

  • Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia

    RECRUITING

    Reggio Emilia, Italy

  • Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapie Cellulari, Policlinico Universitario Campus Bio-Medico

    RECRUITING

    Roma, Italy

  • Fondazione IRCCS San Gerardo dei Tintori -Ematologia

    RECRUITING

    Monza, Italy

  • I.R.C.C.S. Istituto Oncologico Veneto -Oncologia 1

    RECRUITING

    Padova, Italy

  • Ospedale IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuno-correlati

    RECRUITING

    Aviano, Italy

  • Ospedale delle Croci - Ematologia

    RECRUITING

    Ravenna, Italy

  • Policlinico Giaccone - Ematologia

    NOT_YET_RECRUITING

    Palermo, Italy

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