Ireland
--:--IST
Recruiting Phase 2

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

NCT05952024 · tracked via the Priya Life Science Taiwan tracker
Phase
Phase 2
Started
2024-07-16
Last updated
2026-10-30

Condition(s) studied

Diffuse Large B-Cell Lymphoma

Investigational drug(s) / intervention(s)

Acalabrutinib →Rituximab →

Acalabrutinib: Patients will receive acalabrutinib orally with dosing schedule of X.

Rituximab: Patients will receive rituximab via IV infusion on Cycle 1 Day 15 and via SC injection on Day 1 of Cycle 2 through Cycle 8.

Study summary

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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs) — Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) through End of treatment EoT [30 days of discontinuation] (Up to 3.5 Years)

Trial sites (57)

FacilityCityRegionStatus
Research Site Berkeley California Withdrawn
Research Site La Jolla California Completed
Research Site Orange California Withdrawn
Research Site Stamford Connecticut Withdrawn
Research Site Jacksonville Florida Recruiting
Research Site Des Moines Iowa Recruiting
Research Site Lexington Kentucky Withdrawn
Research Site Beltsville Maryland Recruiting
Research Site Towson Maryland Recruiting
Research Site Detroit Michigan Recruiting
Research Site Sioux Falls South Dakota Withdrawn
Research Site Lubbock Texas Recruiting
Research Site Olympia Washington Recruiting
Research Site Tacoma Washington Recruiting
Research Site Barretos Brazil Recruiting
Research Site Belo Horizonte Brazil Recruiting
Research Site Brasília Brazil Recruiting
Research Site Brasília Brazil Recruiting
Research Site Brasília Brazil Recruiting
Research Site Campinas Brazil Recruiting
Research Site Curitiba Brazil Recruiting
Research Site Florianópolis Brazil Recruiting
Research Site Florianópolis Brazil Recruiting
Research Site Goiânia Brazil Recruiting
Research Site Natal Brazil Recruiting
Research Site Porto Alegre Brazil Recruiting
Research Site Porto Alegre Brazil Recruiting
Research Site Recife Brazil Recruiting
Research Site Ribeirão Preto Brazil Recruiting
Research Site Rio de Janeiro Brazil Recruiting
Research Site São José do Rio Preto Brazil Recruiting
Research Site São Luís Brazil Recruiting
Research Site São Paulo Brazil Recruiting
Research Site São Paulo Brazil Recruiting
Research Site São Paulo Brazil Recruiting
Research Site São Paulo Brazil Completed
Research Site São Paulo Brazil Recruiting
Research Site Sorocaba Brazil Recruiting
Research Site San Juan Puerto Rico Recruiting
Research Site Busan South Korea Recruiting

+ 17 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05952024 on ClinicalTrials.gov ↗ ← All trials in Taiwan