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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + Chemotherapy for Non-Hodgkin's Lymphoma
Phase 2
Recruiting
Led By Mark J Roschewski, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a confirmed histologic diagnosis of an aggressive B-cell lymphoma with morphologic appearance of DLBCL or high-grade B-cell lymphoma (HGBL) confirmed by the Laboratory of Pathology, NCI, with no prior treatment for DLBCL or HGBL. The following subtypes are included: DLBCL, NOS, Activated B-cell type (ABC), DLBCL, NOS, Germinal center B-cell type (GCB), T-cell/histiocyte-rich large B-cell lymphoma, Primary cutaneous DLBCL, leg-type, EBV+ DLBCL, NOS, DLBCL associated with chronic inflammation, ALK+ large B-cell lymphoma, High-grade B-cell lymphoma, NOS, High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements. Presence of concomitant indolent lymphomas such as follicular lymphoma, marginal zone lymphomas, monoclonal B-cell lymphocytosis or chronic lymphocytic leukemia/small lymphocytic lymphoma that are best categorized as composite or transformed lymphomas are allowed.
Age greater than or equal to 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initiation of study drug until 30 days after last dose
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can improve the cure rate of aggressive B-cell lymphomas.
Who is the study for?
Adults aged 18+ with untreated aggressive B-cell lymphomas, specifically diffuse large B-cell lymphoma or high-grade B-cell lymphoma. Participants must have measurable disease, adequate organ and marrow function, and be willing to use effective contraception. Pregnant women, those with CNS involvement by the cancer or certain other health conditions are excluded.Check my eligibility
What is being tested?
The trial is testing if adding acalabrutinib (a pill) to standard chemotherapy regimens (DA-EPOCH-R or R-CHOP) along with rituximab improves cure rates in aggressive B-cell lymphomas like diffuse large B-cell lymphoma. The treatment includes up to six cycles of therapy lasting 21 days each.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response, bleeding risks due to blood disorders, possible liver enzyme changes indicating liver issues, fatigue from anemia or general drug effects, and infection risk due to lowered white blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an aggressive type of B-cell lymphoma and have not been treated for it.
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I am 18 years old or older.
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My condition is classified as Stage II, III, or IV by the Ann Arbor system.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ initiation of study drug until 30 days after last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initiation of study drug until 30 days after last dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
Complete response rate
Event-free survival
Overall survival
+2 moreSide effects data
From 2020 Phase 2 trial • 177 Patients • NCT043461992%
Headache
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment4 Interventions
Acalabrutinib 100 mg orally twice a day for 14 days; Following window: patients with > or = to 25% tumor reduction, treat with DA-EPOCH-R or R-CHOP + acalabrutinib 100mg orally twice a day for the first 10 days, for 6 cycles; whereas, patients with <25% tumor reduction, treat with DA-EPOCH-R or R-CHOP alone for 6 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
CHOP
2012
Completed Phase 3
~1460
Acalabrutinib
2020
Completed Phase 2
~2050
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,667 Previous Clinical Trials
40,926,000 Total Patients Enrolled
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,032 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active hepatitis B infection or a positive hepatitis B PCR test.I do not have any other cancer requiring ongoing treatment.My lymphoma has spread to my brain or spinal cord.If your doctor believes that you need urgent chemotherapy to reduce the size of your tumor or prevent organ damage, you cannot participate in the trial.I have received treatment for DLBCL before joining this study.I am not breastfeeding as it may harm my nursing infant due to treatment.I am not pregnant nor planning to become pregnant during the study.I cannot swallow pills or have a condition that affects how my body absorbs them.My lymphoma is not one of the excluded types like PCNSL or PMBL.I have or might have Progressive Multifocal Leukoencephalopathy.I have an uncontrolled immune system disorder that destroys my red blood cells.I have not had major surgery in the last 30 days or have fully recovered if I did.I have an aggressive type of B-cell lymphoma and have not been treated for it.I can provide a tumor sample for study, or I'm willing to have a biopsy if needed.I am 18 years old or older.I do not have an active hepatitis C infection.I do not have serious heart problems or recent heart attacks.I need medication for stomach acid, like omeprazole.My blood counts and organ functions are within the required ranges for the trial.I do not have active bleeding or a history of bleeding disorders like hemophilia.My condition is classified as Stage II, III, or IV by the Ann Arbor system.I have not had a bleeding stroke or brain bleed in the last 6 months.I can take care of myself and am up and about more than half of my waking hours.I do not have an ongoing serious infection.I need medication to prevent blood clots that is similar to warfarin.I need medication that affects how my body processes drugs.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this trial currently underway?
"As reflected on clinicaltrials.gov, this medical experiment is currently in the recruitment stage. It was first advertised on August 5th 2019 and revised most recently on October 20th 2022."
Answered by AI
What is the sample size of this clinical investigation?
"Indeed. The records present on clinicaltrials.gov show that this experiment is currently recruiting volunteers, having first been published on August 5th 2019 and recently updated on October 20th 2022. 132 participants need to be sourced from a single site."
Answered by AI
Does Acalabrutinib pose any serious risks to consumers?
"The safety of acalabrutinib was rated as a 2, reflecting the fact that there is preliminary evidence for its security yet no studies have evaluated it efficacy."
Answered by AI
What affect has Acalabrutinib been observed to have on patients?
"Acalabrutinib is commonly prescribed to treat Diffuse Large B-Cell Lymphoma (DLBCL). Additionally, it has been demonstrated as a successful treatment option for b-cell lymphomas, polyangium, and pemphigus vulgaris."
Answered by AI
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