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Promising combo targets tough lymphoma in seniors

NCT ID NCT03567876

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding the targeted drug venetoclax to standard chemotherapy (R-BAC) helps older patients with high-risk mantle cell lymphoma. 141 patients received the combination, aiming to improve how long they stay cancer-free. The approach is designed for those who cannot tolerate intensive treatments like stem cell transplants.

What this could mean

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

Active substance
Venetoclax (a targeted drug) combined with rituximab, bendamustine, and cytarabine (chemotherapy)
What this could lead to
If successful, this combination could help older patients with high-risk mantle cell lymphoma live longer without their cancer progressing.
What could go wrong
This is a phase 2 trial with 141 patients, so results are still preliminary. The added drug may increase side effects without guaranteeing better outcomes.

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

141 people

The number who actually took part.

Started

Sep 2018

Finished

Oct 2025

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

18 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. Previously untreated patients with MCL aged ≥65 years if they are FIT according to the geriatric CGA assessment. 2. age ≤64 years not eliglible to high-dose chemotherapy plus transplantation at physician's judgement (details for non eligibility to be recorded by means of the CIRS, Cumulative Illness rating Scale). 3. Measurable nodal or extranodal disease ≥ 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions. 4. ECOG performance status ≤2. 5. Positivity for cyclin D1 and/or SOX11 \[the latter being mandatory in cases lacking cyclin D1- or t(11;14)-negative\]. 6. Adequate renal function (Creatinine clearance \>50 mL/min), with preserved diuresis. 7. Adequate liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \<2.5 x upper limit of normal (ULN) value, total bilirubin \<1.5 x ULN, unless directly attributable to the patient's tumor or to congenital causes. 8. Hepatitis B core antibody (HBcAb) positive/HBsAg negative/HBV-DNA negative patients may be enrolled if correct antiviral prophylaxis is administered at least 2 weeks before initiating protocol treatment. 9. Written informed consent. Exclusion Criteria: 1. Human immunodeficiency virus (HIV) positive. 2. Previous treatment for lymphoma. 3. Disease confined to the bone marrow/peripheral blood/spleen, without any other nodal or extranodal involvement. 4. In-situ MCL. 5. Medical conditions or organ injuries that could interfere with administration of therapy. 6. Active bacterial, viral, or fungal infection requiring systemic therapy. 7. Seizure disorders requiring anticonvulsant therapy. 8. Severe chronic obstructive pulmonary disease with hypoxiemia. 9. History of severe cardiac disease: New York Heart Association (NYHA) functional class III-IV, myocardial infarction within 6 months, ventricular tachyarrhythmias, dilatative cardiomyopathy, or unstable angina. 10. Uncontrolled diabetes mellitus. 11. Active secondary malignancy. 12. Known hypersensitivity or anaphylactic reactions to murine antibodies and proteins, to Bendamustine or mannitol. 13. Major surgery within 4 weeks of study Day 1. 14. HBsAg+ 15. HCVAb+ patients with active viral replication (HCV-RNA+ with AST\>2 x normal limit) 16. Any co-existing medical or psychological condition that would preclude participation in the study or compromise the patient's ability to give informed consent, or that may affect the interpretation of the results, or render the patient at high risk from treatment complications. 17. CNS involvement 18. Chronic treatment with strong or moderate CYP3A inhibitors (e.g. ketoconazole, ritonavir, clarithromycin, itraconazole, voriconazole)

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Conditions

The condition(s) this trial relates to.

mantle cell lymphoma

As listed by the trial registrant

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

Lymphoma, mantle cell

Contacts and locations

Locations

  • A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia

    Palermo, Italy

  • A.O. SS. Antonio e Biagio e Cesare Arrigo, SC Ematologia

    Alessandria, Italy

  • A.O.U. Città della Salute e della Scienza di Torino, SC Ematologia

    Torino, Italy

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

    Torino, Italy

  • AOU Maggiore della Carità di Novara, SCDU Ematologia

    Novara, Italy

  • ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia

    Milan, Italy

  • ASST Spedali Civili, Ematologia

    Brescia, Italy

  • Azienda Ospedaliera C. Panico, UOC Ematologia e Trapianto

    Tricase, Italy

  • Azienda Ospedaliera S. Croce e Carle, SC Ematologia

    Cuneo, Italy

  • Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia

    Florence, Italy

  • Azienda Ospedaliera Universitaria Integrata di Verona, UO Ematologia

    Verona, Italy

  • Azienda Ospedaliera Universitaria di Padova, Ematologia

    Padova, Italy

  • Azienda Sanitaria Universitaria Integrata di Udine, Clinica Ematologica

    Udine, Italy

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

    Reggio Emilia, Italy

  • Centro Riferimento Oncologico, S.O.C. Oncologia Medica A

    Aviano, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia

    Milan, Italy

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Ematologia

    Reggio Calabria, Italy

  • IRCCS Istituto Tumori Giovanni Paolo II, UOC Ematologia

    Bari, Italy

  • IRCCS Policlinico S. Matteo, Divisione di Ematologia

    Pavia, Italy

  • Istituto Clinico Humanitas, UO Ematologia

    Rozzano, Italy

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Ematologia

    Meldola, Italy

  • Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia

    Milan, Italy

  • Ospedale Businco, Ematologia

    Cagliari, Italy

  • Ospedale Ca' Foncello, SC Ematologia

    Treviso, Italy

  • Ospedale Guglielmo Da Saliceto, UO Ematologia

    Piacenza, Italy

  • Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda, Ematologia

    Milan, Italy

  • Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Clinica Ematologica

    Genova, Italy

  • Ospedale San Bortolo, Divisione di Ematologia

    Vicenza, Italy

  • Ospedale degli Infermi, UO Ematologia

    Rimini, Italy

  • Ospedale delle Croci, Ematologia

    Ravenna, Italy

  • Ospedale di Circolo, UOC Ematologia

    Varese, Italy

  • Policlinico S. Orsola-Malpighi, Istituto di Ematologia "Seragnoli"

    Bologna, Italy

  • Policlinico Umberto I - Università "La Sapienza", Istituto Ematologia -Dipartimento di Biotecnologie Cellulari ed Ematologia

    Roma, Italy

  • Università Cattolica S. Cuore, Ematologia

    Roma, Italy

  • Università Politecnica delle Marche, Clinica di Ematologia

    Ancona, Italy

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