Trial Title:
Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
NCT ID:
NCT05952024
Condition:
Diffuse Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Rituximab
Acalabrutinib
Conditions: Keywords:
Chemoimmunotherapy treatments
Treatment-naïve elderly patients
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Acalabrutinib
Description:
Patients will receive acalabrutinib orally with dosing schedule of X.
Arm group label:
Acalabrutinib and Rituximab
Other name:
CALQUENCE®
Intervention type:
Biological
Intervention name:
Rituximab
Description:
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.
Arm group label:
Acalabrutinib and Rituximab
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.
Detailed description:
Treatment-naïve elderly and/or frail patients with DLBCL will be treated with
acalabrutinib in combination with rituximab in a single arm.
Study details include the following:
- The study duration will be up to 108 weeks for each patient, including up to 28 days
for screening and 104 weeks of treatment and follow-up.
- The treatment duration will be up to 8 cycles for rituximab and 28 cycles for
acalabrutinib both beginning at cycle 1.
Criteria for eligibility:
Criteria:
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.
- Known to have tested positive for 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 > 6.
- History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.
- Known history of infection with HIV or any 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).
- Any concurrent anticancer treatment.
- 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.
Gender:
All
Minimum age:
65 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Stamford
Zip:
06902
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Beltsville
Zip:
20705
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Towson
Zip:
21204
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sioux Falls
Zip:
57104
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Lubbock
Zip:
79410
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Olympia
Zip:
98506
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Belo Horizonte
Zip:
30150-221
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Brasilia
Zip:
70200-730
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Brasilia
Zip:
70390-700
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Brasilia
Zip:
70840-901
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Campinas
Zip:
13060-803
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Florianópolis
Zip:
88020-210
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Florianópolis
Zip:
88034-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Goiania
Zip:
74605-020
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Natal
Zip:
59075-740
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Porto Alegre
Zip:
90035-003
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Porto Alegre
Zip:
90880-480
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Recife
Zip:
50070-480
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ribeirão Preto
Zip:
14048-900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rio de Janeiro
Zip:
20231-050
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sao Luis
Zip:
65060-645
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Zip:
05652-900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Zip:
1323000
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sorocaba
Zip:
18030-005
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
São José do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
São Paulo
Zip:
01229-010
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
São Paulo
Zip:
01409-02
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
São Paulo
Zip:
04502-001
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
São Paulo
Zip:
08270-070
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Busan
Zip:
47392
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Busan
Zip:
49241
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Daegu
Zip:
42601
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gyeongsangnam-do
Zip:
52727
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Incheon
Zip:
405-760
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Jeonju-si
Zip:
54907
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seo-gu
Zip:
49201
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
07985
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Suwon-si
Zip:
16499
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ulsan
Zip:
44033
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
San Juan
Zip:
00917
Country:
Puerto Rico
Status:
Recruiting
Start date:
July 16, 2024
Completion date:
August 24, 2027
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05952024
