NCT04626791Active, not recruitingPhase 2
Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma
A Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
This phase II trial investigates how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma. Modified VR-CAP is a combination of drugs used as standard first line treatment for mantle cell lymphoma. Chemotherapy drugs, such as bortezomib, cyclophosphamide, doxorubicin hydrochloride, and cytarabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that binds and depletes malignant B cells, by inducing immune responses and direct toxicity. Acalabrutinib blocks a key enzyme which is needed for malignant cell growth in mantle cell lymphoma. Combining modified VR-CAP and acalabrutinib as first line therapy may be more useful against mantle cell lymphoma compared to the usual treatment.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 3 Nov 2020
- Start date
- 3 Aug 2021
- Primary completion date
- 3 Aug 2025
- Lead sponsor
- Academic and Community Cancer Research United
- Diseases
- Mantle cell lymphoma
- NCT number
- NCT04626791
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 41
- From 3 Aug 2021 to the primary completion date, 3 Aug 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic treatment for mantle cell lymphoma. Short course of steroids (=\< 7 days) for symptom management or localized radiation is permissible, as long as measurable disease outside of the radiation field exists
- Prior exposure to bortezomib or a BTK inhibitor
- Prior anthracycline exposure unless cumulative prior exposure is under 150 mg per square meter
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer
- Requiring treatment with a proton pump inhibitor. Examples include: dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, or therapeutic class equivalents
- Note: H2-receptor agonists are not exclusionary
- Active or chronic uncontrolled hepatitis B or hepatitis C infection. Patients with positive hepatitis B core antibody positive require negative polymerase chain reaction (PCR) prior to enrollment. Hepatitis B surface antigen positive or PCR positive patients will be excluded. Patients with hepatitis C must have negative hepatitis C virus (HCV) ribonucleic acid (RNA) for inclusion
- Co-morbid systemic illnesses or other severe concurrent disease (including major surgery within 2 weeks) which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening. unless directly due to MCL Involvement by endoscopic or histologic evaluation
- Major surgical procedure within 28 days of first dose of study drug. NOTE: 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
- Concurrent participation in another therapeutic clinical trial
Other illness
- Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura)
- Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease)
- History of allergic reactions attributed to acalabrutinib, cytarabine, bortezomib, boron, or any of the other agents administered as part of the therapeutic regimen in this study
- Active systemic fungal, bacterial, viral, or other infection that is worsening (defined as increasing signs/symptoms of infection during screening) or, requires intravenous antibiotic therapy
- Known to be human immunodeficiency virus (HIV) positive since antiretroviral therapy has a potential for drug interactions with acalabrutinib
- Has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication
Lab values
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure or low cardiac ejection fraction (New York Heart Association \[NYHA\] class 3-4 or ejection fraction \[EF\] \< 45%), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Age
- Other active malignancy =\< 2 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer localized prostate cancer, or carcinoma-in-situ of the breast or cervix. NOTE: If there is a history or prior malignancy, patients must not be receiving other specific treatment for their cancer
Other
- Peripheral neuropathy or neuropathic pain of grade 2 or worse as assessed by the investigator
- Requiring anticoagulation with warfarin or equivalent vitamin k antagonist
- Pregnant and/or breastfeeding
Who the study is looking for
- Age 18-75 years
- No prior therapy for mantle cell lymphoma (MCL)
- MCL in need of systemic therapy, and potentially eligible for ASCT as assessed by the treating physician
- Documented histological confirmation of MCL by local institutional review
- Documented, fludeoxyglucose F-18 (FDG)-avid measurable disease (at least 1 lesion \>= 1.5 cm in diameter) as detected by positron emission tomography (PET)/computed tomography (CT) and as defined and includes measurable nodal and extranodal disease sites, or splenomegaly measuring more than 13 cm in vertical length
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
- Absolute neutrophil count (ANC) \>= 1000/mm\^3 or \>= 500/mm\^3 if due to lymphomatous marrow or spleen involvement (obtained =\< 30 days prior to registration)
- Platelet count \>= 100,000/mm\^3 or \>= 75,000/mm\^3 if due to lymphomatous marrow or spleen involvement (obtained =\< 30 days prior to registration)
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which total bilirubin =\< 3 x upper limit of normal \[ULN\] is permitted) (obtained =\< 30 days prior to registration)
- Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 30 days prior to registration)
- Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) =\< 2 x ULN, unless elevated due to a lupus anticoagulant (obtained =\< 30 days prior to registration)
- Calculated creatinine clearance must be \>= 30 ml/min using the Cockcroft-Gault formula (obtained =\< 30 days prior to registration)
- Negative pregnancy test done within =\< 14 days prior to registration for women of childbearing potential only
- For women of childbearing potential (WOCBP, defined as premenopausal women capable of becoming pregnant): Must agree to use of highly effective method of birth control during study therapy and until 12 months after last dose of study therapy. NOTE: 'Acceptable' methods are not adequate. Highly effective methods are defined by Clinical Trials Facilitation and Coordination Group \[CTFG\] as having a failure rate of \< 1% per year
- Men must agree to use barrier contraception starting with the first dose of study therapy and through 180 days after completion of study therapy
- Provide informed written consent
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
- Hematologic labs must be obtained within =\< 14 days of registration
- Willing and able to participate in all required evaluations and procedures in this study protocol
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Carolinas Medical Center/Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Washington Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.