Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma (NCT04002947) | Clinical Trial Compass
RecruitingPhase 2
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
United States132 participantsStarted 2019-08-05
Plain-language summary
Background:
Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Most people with this cancer can be cured. But those who are not cured have a poor prognosis. Researchers want to add another drug to standard treatment see if it can improve the cure rate.
Objective:
To see if the drug acalabrutinib given with rituximab and standard combination chemotherapy can improve the cure rate of aggressive B-cell lymphomas such as diffuse large B-cell lymphoma.
Eligibility:
People ages 18 and older with an aggressive B-cell lymphomas that have not been treated
Design:
Participants will be screened with:
Blood and urine tests
Physical exam
Medical history
Tumor biopsy
Bone marrow biopsy: A needle will remove marrow from the participant s hipbone.
Lumbar puncture: If necessary, a needle will remove fluid from the participant s spinal canal.
Imaging scans
Participants will take the study drug for up to 14 days. It is a pill taken 2 times a day. Then they will have more scans. They will get rituximab and chemotherapy. They may get these drugs through a needle in an arm vein. Or they may them through a tube placed in a vein in their chest or in their neck. They might also keep taking the study drug. Each treatment cycle lasts 21 days. They will have up to 6 cycles.
Participants may have 4 doses of another drug injected into their spinal fluid.
Participants will have repeats of the screening tests throughout the study.
Participants will have a follow-up visit 30 days after their last treatment, then every 3 months for 2 years, then every 6 months for 3 years, and then yearly.
...
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. A formalin-fixed tissue block or 15 slide of tumor sample (archival or fresh) must be available for performance of correlative studies.
. Measurable lymph nodes or masses of at least 1.5 centimeters (cm) on baseline CT or MRI
. Stage II, III, or IV disease as classified by the Ann Arbor Classification
. Age greater than or equal to 18 years
. ECOG performance status less than or equal to 2.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing acalabrutinib added to either DA-EPOCH-R or R-CHOP for untreated DLBCL — can you help me understand why adding acalabrutinib to these standard chemotherapy regimens might be beneficial for my specific type of DLBCL, and whether my subtype is one this combination is intended to target?
2Since this is a Phase 2 trial, the main goal is measuring response rate rather than confirming long-term survival benefit — what does that mean for what we currently know about safety and effectiveness compared to just doing standard R-CHOP on its own?
3The trial uses two different chemotherapy backbones, DA-EPOCH-R and R-CHOP — would you be able to tell me which one I'd likely receive, and how does the intensity difference between those two regimens factor into the risks I'd be taking on?
4Acalabrutinib is a BTK inhibitor that can have its own side effects like bleeding, heart rhythm changes, or infections on top of chemotherapy — given my overall health, are there specific risks from combining it with these regimens that I should be especially aware of?
5Since this trial is still actively recruiting and I have newly diagnosed DLBCL, would it make more sense to start with a proven standard-of-care regimen first, or is there a reason you'd recommend considering this trial now before beginning any treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Adequate organ and marrow function as defined below unless dysfunction is felt to be secondary to lymphoma involvement as determined by the treating investigator:
Creatinine clearance \>=40 mL/min/1.73 m2 for patients with creatinine levels above 2 mg/dL
Exclusion criteria
. Patients who meet histologic criteria for the following subtypes are excluded:
. Patients who, at the discretion of the investigator, need immediate cytoreductive chemotherapy such as patients with evidence of spontaneous tumor lysis or impending organ compromise are not eligible.
. Current or prior anti-cancer treatment for DLBCL prior to enrollment. Short course of corticosteroids (\<7 days) for acute issues prior to study enrollment are permitted.
. Major surgical procedure within 30 days of first dose of study drug. If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug
. Requires treatment with moderate or strong CYP3A inhibitors or inducers
. Known lymphomatous involvement of the CNS
. Pregnant individuals, or individuals who intend to become pregnant during the study are excluded from this study because of potential teratogenic effects associated with acalabrutinib, R-CHOP, and/or DA-EPOCH-R
. The potential for all study treatments to be excreted in the milk of nursing mothers is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with acalabrutinib, nursing must be discontinued.