Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Peripheral neuropathy or neuropathic pain of grade 2 or worse as assessed by the
investigator
- Prior exposure to bortezomib or a BTK inhibitor
- Prior anthracycline exposure unless cumulative prior exposure is under 150 mg per
square meter
- Requiring anticoagulation with warfarin or equivalent vitamin k antagonist
- 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 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
- 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
- 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
- Known to be human immunodeficiency virus (HIV) positive since antiretroviral therapy
has a potential for drug interactions with acalabrutinib
- 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
- Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm
- 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
- Pregnant and/or breastfeeding
- Has difficulty with or is unable to swallow oral medication, or has significant
gastrointestinal disease that would limit absorption of oral medication
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 8/3/23. Questions regarding updates should be directed to the study team contact.