Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma (NCT04566887) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma
Canada105 participantsStarted 2021-03-01
Plain-language summary
This is a multicenter, open-label, non-randomized, phase II clinical trial conducted in Canada. The purpose of the study is to determine the remission rate of acalabrutinib in combination with R-CHOP in patients with previously untreated mantle cell lymphoma prior to autologous stem cell transplantation. This study is composed of 2 cohorts, A and B. In Cohort A all patients will receive six cycles of R-CHOP chemotherapy together with continuous acalabrutinib at the standard dose twice per day orally. All patients will undergo response assessment at the end of six cycles of R-CHOP + acalabrutinib with CT scan, PET/CT scan, and bone marrow biopsy. Responding patients will proceed with stem cell mobilization, apheresis, and processing. Following ASCT, patients will receive standard maintenance rituximab every 3 months for 2 years. Enrollment for Cohort A component of the study has been completed. Cohort B, involves using acalabrutinib with R-CHOP (same as Group A) but without an autologous stem cell transplant (ASCT) as part of the regimen. The study doctors hope to evaluate how participants respond to the treatment in terms of the time between treatment initiation and time when stable disease is achieved. The enrollment for cohort B is currently ongoing.
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
. Men and women greater than or equal to 18 years of age deemed eligible for treatment with Full dose RCHOP and ASCT by the qualified investigator.
. Histologic diagnosis of MCL according to the World Health Organization classification \[Swerdlow, Blood 2016\].
. Previously untreated MCL with the following exceptions: (a) prior radiotherapy for localized disease, (b) up to 7 days of corticosteroids (prednisone 100mg/day equivalent), (c) up to one dose of single-agent chemotherapy (for example, cyclophosphamide), (d) up to one cycle of R-CHOP if last R-CHOP is between 21 days and 2 months from start of RCHOP+acalabrutinib or up to one cycle ofbendamustine-rituximab (BR) if BR is between 28 days and 2 months from start of RCHOP+acalabrutinib. Patients with exceptions (c) and (d) are eligible as long as all other eligibility criteria are met AND at least a CT scan and bone marrow biopsy were performed prior to chemotherapy.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 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 combines acalabrutinib with R-CHOP chemotherapy — how does adding a BTK inhibitor like acalabrutinib to standard R-CHOP change the side effect profile I should be prepared for compared to R-CHOP alone?
2The trial is in Phase 2, which means it's still building evidence on how well this combination works — given that, how does the current evidence for this approach compare to what's already known about standard R-CHOP or other established treatments for mantle cell lymphoma in my situation?
3Since this trial is no longer actively recruiting, is there any chance I could still be considered for enrollment, or would my doctor recommend a similar approach through a different open study or standard care?
4Cohort B involves two full years of maintenance therapy with acalabrutinib and rituximab after the initial treatment — given my work schedule, health, and support at home, is that kind of long-term commitment realistic for my situation?
5The trial measures success partly through PET/CT scans using the Lugano Classification — how often would I need those scans during and after treatment, and what would the findings mean for decisions about continuing or changing my care?
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.
What they're measuring
1
Complete response (CR) rate by PET/CT scan using Lugano Classification for Malignant Lymphoma - Cohort A
Timeframe: 1-2 weeks after completing six cycles (21 days) of R-CHOP + acalabrutinib.
2
To evaluate FFS in patients receiving acalabrutinib + R-CHOP followed by 2 years of maintenance acalabrutinib + rituximab - Cohort B
Timeframe: 2-year failure-free survival (FFS), defined as time from treatment initiation to stable disease after at least 4 cycles of induction, relapse/progression at any time, or death from any cause
. Presence of at least one radiologically measurable nodal or extranodal mass. A measurable nodal mass must have a longest diameter ≥1.5 cm. A measurable extranodal mass should have a longest diameter ≥1.0 cm.\[Cheson, JCO 2014\]
. Women of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and up to 12 months after the last dose of rituximab or R-CHOP, or 2 days after the last dose of acalabrutinib, whichever is last administered. Examples of highly effective contraceptive methods include an agreement to remain abstinent (ie, refrain from heterosexual intercourse), bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Men who are sexually active must use highly effective methods of contraception during treatment and up to 6 months after the last dose of rituximab or R-CHOP, or 2 days after the last dose of acalabrutinib, whichever is last administered. Men require an agreement to remain abstinent (ie, refrain from heterosexual intercourse) or use a condom, and an agreement to refrain from donating sperm. Periodic abstinence and withdrawal are not acceptable methods of contraception. Fertility preservation options should be discussed.
. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information.
Exclusion criteria
. Secondary central nervous system involvement.
. Prior exposure to a BCR inhibitor (eg, BTK inhibitors, phosphoinositide-3 kinase (PI3K), or Syk inhibitors) or BCL-2 inhibitor.
. Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or prostate cancer, or other cancer from which the subject has been disease free for ≥ 3 years or which will not limit survival to \< 5 years. Subjects receiving adjuvant hormonal therapy for early breast or prostate cancer are eligible.
. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study.
. Difficulty with or unable to swallow oral medication, or conditions significantly affecting gastrointestinal function that would limit absorption of oral medication.
. Known history of infection with HIV or any significant active infection (eg, bacterial, viral or fungal), including suspected or confirmed progressive multifocal leukoencephalopathy.
. Known history of drug-specific hypersensitivity or anaphylaxis to study drugs (acalabrutinib and individual components of R-CHOP), including active product or excipient components.
. Active bleeding or history of bleeding diathesis (eg, hemophilia or von Willebrand disease).