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New drug combo offers hope for elderly lymphoma patients too frail for chemo

NCT ID NCT05952024

Disease control Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 6 times

Summary

This study tests a combination of two drugs, acalabrutinib and rituximab, in elderly or frail patients with untreated diffuse large B-cell lymphoma who cannot receive standard chemotherapy. About 80 participants will receive the drugs orally and by injection. The main goal is to see how safe and tolerable the combination is, and whether it can control the cancer.

What this could mean

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

Active substance
acalabrutinib and rituximab
What this could lead to
If it works, this could offer a gentler, effective treatment option for older or 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 without a comparison group, so results may not be definitive. The combination may still cause significant side effects or fail to control the cancer 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 80 people

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

Started

Jul 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

65 to 99 years

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: * ≥ 80 years of age at the time of screening, or * ≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy * Histologically documented DLBCL * No prior treatment for DLBCL * Stage II, III, or IV disease by the Ann Arbor Classification . * Eastern Cooperative Oncology Group performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of the first dosing except when due to underlying lymphoma. * At least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography or magnetic resonance imaging and is suitable for accurate repeated measurements. * Adequate organ and marrow function independent of growth factor or transfusion support within 1 week of Screening. Exclusion Criteria: * Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active bleeding diseases), that would make the study undesirable for the patient or that would impact compliance with the protocol. * History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results. * Serologic status reflecting active hepatitis B or C infection. * Serological positivity or known infection with HIV. * Active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression. * Any comorbidity or organ system impairment rated with a single Cumulative Illness Rating Scale-Geriatric score (CIRS-G) of 4 or a total CIRS-G score of \> 17. * History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy. * Known active significant infection. * History of stroke or intracranial haemorrhage within 6 months before the first dose of study drug. * History of bleeding diathesis (eg, haemophilia, von Willebrand disease). * Major surgical procedure within 30 days of first dose of study intervention or anticipated major surgery during the study timeframe. * Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists. * Received a live virus vaccination within 28 days of the first dose of study drug.

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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 lymphoma

How to take part

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

  1. The places running it

    6 sites in 3 countries. 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

  • Research Site

    WITHDRAWN

    Berkeley, California, 94704, United States

  • Research Site

    COMPLETED

    La Jolla, California, 92093, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Orange, California, 92868, United States

  • Research Site

    WITHDRAWN

    Stamford, Connecticut, 06902, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Jacksonville, Florida, 32256, United States

  • Research Site

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • Research Site

    WITHDRAWN

    Lexington, Kentucky, 40536, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Beltsville, Maryland, 20705, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Towson, Maryland, 21204, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48202, United States

  • Research Site

    WITHDRAWN

    Sioux Falls, South Dakota, 57104, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Lubbock, Texas, 79410, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Olympia, Washington, 98506, United States

  • Research Site

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Barretos, 14784-400, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Belo Horizonte, 30150-221, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Brasília, 70200-730, Brazil

  • Research Site

    RECRUITING

    Brasília, 70390-700, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Brasília, 70840-901, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Campinas, 13060-803, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Curitiba, 81520-060, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Florianópolis, 88020-210, Brazil

  • Research Site

    RECRUITING

    Florianópolis, 88034-000, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Goiânia, 74605-020, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Natal, 59075-740, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Porto Alegre, 90035-003, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Porto Alegre, 90880-480, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Recife, 50070-480, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Ribeirão Preto, 14048-900, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Rio de Janeiro, 20231-050, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    São José do Rio Preto, 15090-000, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    São Luís, 65060-645, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    São Paulo, 01229-010, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    São Paulo, 01409-02, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    São Paulo, 05652-900, Brazil

  • Research Site

    COMPLETED

    São Paulo, 08270-070, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    São Paulo, 1323000, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    Sorocaba, 18030-005, Brazil

  • Research Site

    ACTIVE_NOT_RECRUITING

    San Juan, 00917, Puerto Rico

  • Research Site

    RECRUITING

    Busan, 47392, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Busan, 49241, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Daegu, 42601, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Gyeongsangnam-do, 52727, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Incheon, 405-760, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Jeonju, 54907, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Seogu, 49201, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Seoul, 05505, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Seoul, 06591, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Seoul, 07985, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Suwon, 16499, South Korea

  • Research Site

    ACTIVE_NOT_RECRUITING

    Ulsan, 44033, South Korea

  • Research Site

    WITHDRAWN

    Kaohsiung City, 80756, Taiwan

  • Research Site

    WITHDRAWN

    Kaohsiung City, 833, Taiwan

  • Research Site

    WITHDRAWN

    Tainan, 736, Taiwan

  • Research Site

    WITHDRAWN

    Taipei, 100, Taiwan

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