RECRUITING

Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL

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Conditions

Diffuse Large B-Cell LymphomaChemoimmunotherapy treatmentsTreatment-naïve elderly patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will measure the safety, tolerability, and efficacy with acalabrutinib in combination with rituximab in treatment-naïve elderly and/or frail patients with diffuse large B-cell lymphoma (DLBCL), who are otherwise unsuitable for standard front line chemoimmunotherapy treatments.

Official Title

A Prospective, Open-Label, Single-Arm, Phase II Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With Diffuse Large B-Cell Lymphoma (ACRUE)

Quick Facts

Study Start:2024-07-16
Study Completion:2027-08-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05952024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 80 years of age at the time of screening, or
  2. * ≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy
  3. * Histologically documented DLBCL
  4. * No prior treatment for DLBCL
  5. * Stage II, III, or IV disease by the Ann Arbor Classification .
  6. * 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.
  7. * 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.
  8. * Adequate organ and marrow function independent of growth factor or transfusion support within 1 week of Screening.
  1. * 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.
  2. * History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results.
  3. * Serologic status reflecting active hepatitis B or C infection.
  4. * Serological positivity or known infection with HIV.
  5. * Active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression.
  6. * 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.
  7. * History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.
  8. * Known active significant infection.
  9. * History of stroke or intracranial haemorrhage within 6 months before the first dose of study drug.
  10. * History of bleeding diathesis (eg, haemophilia, von Willebrand disease).
  11. * Major surgical procedure within 30 days of first dose of study intervention or anticipated major surgery during the study timeframe.
  12. * Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
  13. * Received a live virus vaccination within 28 days of the first dose of study drug.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
La Jolla, California, 92093
United States
Research Site
Orange, California, 92868
United States
Research Site
Stamford, Connecticut, 06902
United States
Research Site
Jacksonville, Florida, 32256
United States
Research Site
Des Moines, Iowa, 50309
United States
Research Site
Lexington, Kentucky, 40536
United States
Research Site
Beltsville, Maryland, 20705
United States
Research Site
Towson, Maryland, 21204
United States
Research Site
Detroit, Michigan, 48202
United States
Research Site
Sioux Falls, South Dakota, 57104
United States
Research Site
Lubbock, Texas, 79410
United States
Research Site
Olympia, Washington, 98506
United States
Research Site
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-16
Study Completion Date2027-08-24

Study Record Updates

Study Start Date2024-07-16
Study Completion Date2027-08-24

Terms related to this study

Keywords Provided by Researchers

  • Chemoimmunotherapy treatments
  • Treatment-naïve elderly patients

Additional Relevant MeSH Terms

  • Diffuse Large B-Cell Lymphoma