Actively Recruiting

Phase 2
Age: 65Years - 99Years
All Genders
NCT05952024

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

Led by AstraZeneca · Updated on 2026-05-05

80

Participants Needed

57

Research Sites

244 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 80 years of age or older at screening, or 65 to 79 years of age and not eligible for chemoimmunotherapy
  • Histologically confirmed diffuse large B-cell lymphoma (DLBCL)
  • No prior treatment for DLBCL
  • Stage II, III, or IV disease based on Ann Arbor Classification
  • Eastern Cooperative Oncology Group performance status of 0, 1, or 2 without recent deterioration except due to lymphoma
  • At least one measurable lesion of 10 mm or larger on CT or MRI suitable for repeated measurement
  • Adequate organ and bone marrow function within 1 week of screening, independent of growth factor or transfusion support
Not Eligible

You will not qualify if you...

  • Severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, or active bleeding diseases
  • History of prior or current malignancy affecting study compliance or result interpretation
  • Active hepatitis B or C infection
  • Known HIV infection or positive serologic status
  • Active central nervous system lymphoma involvement, leptomeningeal disease, or spinal cord compression
  • Comorbidities with a CIRS-G score of 4 in any organ or total score above 17
  • History or ongoing progressive multifocal leukoencephalopathy
  • Known active significant infections
  • Stroke or intracranial hemorrhage within 6 months before first study drug dose
  • History of bleeding disorders such as hemophilia or von Willebrand disease
  • Major surgery within 30 days before first study drug dose or planned major surgery during study
  • Requirement for or use of warfarin or similar vitamin K antagonists
  • Live virus vaccination within 28 days before first study drug dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 57 locations

1

Research Site

Berkeley, California, United States, 94704

Withdrawn

2

Research Site

La Jolla, California, United States, 92093

Completed

3

Research Site

Orange, California, United States, 92868

Actively Recruiting

4

Research Site

Stamford, Connecticut, United States, 06902

Withdrawn

5

Research Site

Jacksonville, Florida, United States, 32256

Active, Not Recruiting

6

Research Site

Des Moines, Iowa, United States, 50309

Actively Recruiting

7

Research Site

Lexington, Kentucky, United States, 40536

Withdrawn

8

Research Site

Beltsville, Maryland, United States, 20705

Active, Not Recruiting

9

Research Site

Towson, Maryland, United States, 21204

Active, Not Recruiting

10

Research Site

Detroit, Michigan, United States, 48202

Active, Not Recruiting

11

Research Site

Sioux Falls, South Dakota, United States, 57104

Withdrawn

12

Research Site

Lubbock, Texas, United States, 79410

Active, Not Recruiting

13

Research Site

Olympia, Washington, United States, 98506

Active, Not Recruiting

14

Research Site

Tacoma, Washington, United States, 98405

Actively Recruiting

15

Research Site

Barretos, Brazil, 14784-400

Active, Not Recruiting

16

Research Site

Belo Horizonte, Brazil, 30150-221

Active, Not Recruiting

17

Research Site

Brasília, Brazil, 70200-730

Active, Not Recruiting

18

Research Site

Brasília, Brazil, 70390-700

Actively Recruiting

19

Research Site

Brasília, Brazil, 70840-901

Active, Not Recruiting

20

Research Site

Campinas, Brazil, 13060-803

Active, Not Recruiting

21

Research Site

Curitiba, Brazil, 81520-060

Active, Not Recruiting

22

Research Site

Florianópolis, Brazil, 88020-210

Active, Not Recruiting

23

Research Site

Florianópolis, Brazil, 88034-000

Actively Recruiting

24

Research Site

Goiânia, Brazil, 74605-020

Active, Not Recruiting

25

Research Site

Natal, Brazil, 59075-740

Active, Not Recruiting

26

Research Site

Porto Alegre, Brazil, 90035-003

Active, Not Recruiting

27

Research Site

Porto Alegre, Brazil, 90880-480

Active, Not Recruiting

28

Research Site

Recife, Brazil, 50070-480

Active, Not Recruiting

29

Research Site

Ribeirão Preto, Brazil, 14048-900

Active, Not Recruiting

30

Research Site

Rio de Janeiro, Brazil, 20231-050

Active, Not Recruiting

31

Research Site

São José do Rio Preto, Brazil, 15090-000

Actively Recruiting

32

Research Site

São Luís, Brazil, 65060-645

Active, Not Recruiting

33

Research Site

São Paulo, Brazil, 01229-010

Active, Not Recruiting

34

Research Site

São Paulo, Brazil, 01409-02

Active, Not Recruiting

35

Research Site

São Paulo, Brazil, 05652-900

Active, Not Recruiting

36

Research Site

São Paulo, Brazil, 08270-070

Completed

37

Research Site

São Paulo, Brazil, 1323000

Active, Not Recruiting

38

Research Site

Sorocaba, Brazil, 18030-005

Active, Not Recruiting

39

Research Site

San Juan, Puerto Rico, 00917

Active, Not Recruiting

40

Research Site

Busan, South Korea, 47392

Actively Recruiting

41

Research Site

Busan, South Korea, 49241

Active, Not Recruiting

42

Research Site

Daegu, South Korea, 42601

Active, Not Recruiting

43

Research Site

Gyeongsangnam-do, South Korea, 52727

Active, Not Recruiting

44

Research Site

Incheon, South Korea, 405-760

Active, Not Recruiting

45

Research Site

Jeonju, South Korea, 54907

Active, Not Recruiting

46

Research Site

Seogu, South Korea, 49201

Active, Not Recruiting

47

Research Site

Seoul, South Korea, 03722

Active, Not Recruiting

48

Research Site

Seoul, South Korea, 05505

Active, Not Recruiting

49

Research Site

Seoul, South Korea, 06351

Active, Not Recruiting

50

Research Site

Seoul, South Korea, 06591

Actively Recruiting

51

Research Site

Seoul, South Korea, 07985

Active, Not Recruiting

52

Research Site

Suwon, South Korea, 16499

Active, Not Recruiting

53

Research Site

Ulsan, South Korea, 44033

Active, Not Recruiting

54

Research Site

Kaohsiung City, Taiwan, 80756

Withdrawn

55

Research Site

Kaohsiung City, Taiwan, 833

Withdrawn

56

Research Site

Tainan, Taiwan, 736

Withdrawn

57

Research Site

Taipei, Taiwan, 100

Withdrawn

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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