BridgeMD
New treatment option for Mantle Cell Lymphoma
Official title Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT04626791
What this study is testing
What is Acalabrutinib?
Acalabrutinib is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for mantle cell lymphoma.
Also referred to as ACP-196, Bruton Tyrosine Kinase Inhibitor ACP-196.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- Prior systemic treatment for mantle cell lymphoma. Short course of steroids (=\< 7 days) for symptom management or localized radiation is...
- 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)
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- Concurrent participation in another therapeutic clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- New Orleans, Louisiana, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Seattle, Washington, United States
- Wauwatosa, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Orleans, Louisiana, United States; Minneapolis, Minnesota, United States; New York, New York, United States; Charlotte, North Carolina, United States; Seattle, Washington, United States; Wauwatosa, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.