Actively Recruiting
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
Eligibility Criteria
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
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
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
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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