Treatment for elderly patients with untreated diffuse large B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerability, and efficacy of acalabrutinib combined with rituximab in elderly and/or frail patients who have not received prior treatment for diffuse large B-cell lymphoma (DLBCL). The trial focuses on patients who are unsuitable for standard chemoimmunotherapy, aiming to provide an alternative treatment option. Participants will undergo treatment for up to 104 weeks, with assessments of their response to the therapy throughout the study duration.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Jacksonville, Florida, United States Recruiting
• Research Site
  Des Moines, Iowa, United States Recruiting
• Research Site
  Beltsville, Maryland, United States Recruiting
• Research Site
  Towson, Maryland, United States Recruiting
• Research Site
  Detroit, Michigan, United States Recruiting
• Research Site
  Lubbock, Texas, United States Recruiting

+7 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining Acalabrutinib with R-miniCHOP for older adults with untreated diffuse large B-cell lymphoma

  This study tests if adding Acalabrutinib to the usual treatment for older adults with untreated diffuse large B-cell lymphoma can help them live longer without their cancer getting worse.

  Recruiting at 9 sites Phase 3 Universität des Saarlandes · Homburg, Saarland and 16 other locations · NCT05820841

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL

  This study tests whether glofitamab with chemotherapy (JS203-GemOx) helps patients with relapsed or refractory DLBCL more than rituximab with chemotherapy.

  Recruiting Phase 3 Shanghai Junshi Bioscience Co., Ltd. · Beijing, Beijing Municipality · NCT07808827

• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

  This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.

  Recruiting Phase 1 Case Comprehensive Cancer Center · Cleveland, Ohio and 1 other locations · NCT07225439

• Combining pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin for elderly diffuse large B‑cell lymphoma

  This tests whether adding polatuzumab vedotin to a pomalidomide, rituximab and orelabrutinib regimen helps patients aged 70 and older with newly diagnosed diffuse large B‑cell lymphoma.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07072208

• Pola‑R‑GemOx chemotherapy for relapsed/refractory DLBCL in patients who cannot have an autologous transplant

  This trial will test whether adding polatuzumab vedotin to rituximab, gemcitabine, and oxaliplatin helps people with relapsed or refractory DLBCL who are not eligible for autologous stem‑cell transplant.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT07001540

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.