Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma.
Mark Roschewski, David M Kurtz, Jason R Westin...
https://pubmed.ncbi.nlm.nih.gov/40802906Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04002947
A Phase 2 Study of Acalabrutinib With DA-EPOCH-R or R-CHOP for Patients With Untreated Diffuse Large B-cell Lymphoma
Led by National Cancer Institute (NCI) · Updated on 2026-06-03
132
Participants Needed
1
Research Sites
200 weeks
Total Duration
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AI-Summary
What this Trial Is About
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma, and while many patients can be cured, those who are not cured face a poor prognosis. Researchers are studying whether adding the drug acalabrutinib to standard treatments like rituximab combined with chemotherapy regimens DA-EPOCH-R or R-CHOP can improve cure rates in people with untreated aggressive B-cell lymphomas, including molecular subtypes of DLBCL. Participants first receive acalabrutinib pills twice daily for 14 days during an initial treatment window. Based on tumor response measured by scans, those with significant tumor reduction continue treatment with acalabrutinib plus chemoimmunotherapy (either DA-EPOCH-R or R-CHOP) for up to six 21-day cycles, while others receive chemoimmunotherapy alone. Some may also receive additional doses of medication injected into spinal fluid. Treatment administration can be through vein injections or central lines. Throughout the study, participants undergo various tests including blood and urine tests, physical exams, tumor and bone marrow biopsies, lumbar punctures if needed, and imaging scans at regular intervals. Follow-up visits occur 30 days after treatment ends, then every three months for two years, every six months for three years, and yearly thereafter. Researchers will measure response rates, safety, survival outcomes, and treatment tolerability over time.
CONDITIONS
Brief Title
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of aggressive B-cell lymphoma including DLBCL subtypes or high-grade B-cell lymphoma with no prior treatment
- Available tumor tissue sample for studies or willingness to have a biopsy
- Measurable lymph nodes or masses at least 1.5 cm on scans
- Stage II, III, or IV disease
- Age 18 years or older
- ECOG performance status 0 to 2
- Adequate organ and marrow function as defined by blood counts and chemistry
- Negative pregnancy test if of childbearing potential and use of highly effective contraception
- Willingness and ability to sign informed consent
- HIV status confirmed (positive or negative)
You will not qualify if you...
- Histologic subtypes such as primary CNS lymphoma, primary mediastinal B-cell lymphoma, plasmablastic lymphoma, intravascular large B-cell lymphoma, or unclassifiable B-cell lymphoma with Hodgkin features
- Need for immediate cytoreductive chemotherapy due to tumor lysis or organ compromise
- Prior anti-cancer treatment for DLBCL (except short corticosteroids under 7 days)
- Major surgery within 30 days before study drug
- Use of moderate or strong CYP3A inhibitors or inducers
- Known CNS lymphoma involvement
- Pregnancy or intention to become pregnant during study
- Nursing mothers
- Uncontrolled infections or serious illnesses including active hepatitis B or C, bleeding disorders, recent stroke, significant heart disease, autoimmune hemolytic anemia
- Inability to swallow oral medication or conditions affecting absorption
- Mental or physical illness interfering with study participation
- Concurrent participation in another therapeutic clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Run-in Period
Duration - 14 days
Participants receive acalabrutinib orally twice daily for 14 days to assess initial tumor response.
1 to 2 visits for tumor assessment
Treatment
Duration - 6 cycles of 21 days each
Participants receive chemoimmunotherapy with either DA-EPOCH-R or R-CHOP, with or without acalabrutinib based on tumor response during the run-in period.
6 treatment cycles with acalabrutinib given twice daily on days 1-10 of each cycle for those with sufficient tumor reduction
Follow-up
Duration - up to 5 years with assessments every 3-6 months, then yearly
Participants are monitored for safety, progression-free survival, overall survival, and event-free survival after treatment completion.
regular follow-up visits every 3-6 months for 5 years, then yearly visits
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
N
NCI Medical Oncology Referral Office
C
Christopher J Melani, M.D.
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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