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New treatment option for Mantle-cell Lymphoma
Official title A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain
ClinicalTrials.gov ID: NCT07029737
What this study is testing
What is Acalabrutinib combination with Rituximab?
Acalabrutinib combination with Rituximab is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for mantle-cell lymphoma.
Also referred to as Maintenance Phase.
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 is a single-arm, open-label, multicenter, non-indication seeking phase II trial to describe the efficacy and safety of patients with mantle cell lymphoma (MCL) receiving acalabrutinib in combination with R-CHOP for the front-line treatment of MCL in Spain. Acalabrutinib will be administered until disease progression if medically appropriate, along with R-CHOP based on institutional standards.
- Phase 2: a mid-size study of how well it works
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 130
You may be able to join if
- Adult men or women.
- Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with...
- MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
- Unsuitable for autologous stem cell transplantation.
- Presence of radiologically measurable lymphadenopathy, splenomegaly and/or extranodal lymphoid malignancy.
You likely can't join if
- History of prior malignancy except for the following:
- Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low...
- Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer.
- Adequately treated carcinoma in situ without current evidence of disease.
- people for whom the goal of therapy is tumor debulking before stem cell transplant.
- people who are deemed by the treating physician to be unfit to tolerate the R-CHOP regimen.
See the full eligibility criteria
Who can join
- Adult men or women.
- Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers.
- MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
- Unsuitable for autologous stem cell transplantation.
- Presence of radiologically measurable lymphadenopathy, splenomegaly and/or extranodal lymphoid malignancy.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study treatment and for 12 months after the last dose of rituximab or cyclophosphamide, 6 months...
- Men must agree to refrain from sperm donation during the study treatment and for 12 months after the last dose of rituximab or cyclophosphamide, 6 months after the last dose of doxorubicin, 30 days after the last dose...
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing tablets 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 (in accordance with national and local patient privacy...
- WOCBP who are sexually active must use highly effective methods of contraception during the study treatment and for 12 months after the last dose of rituximab or cyclophosphamide, 6 months after the last dose of...
- Male patients should use barrier contraception from the time of screening until 12 months after the last dose of rituximab or cyclophosphamide, 6 months after the last dose of doxorubicin, 30 days after the last dose of...
What rules you out
- History of prior malignancy except for the following:
- Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low risk for recurrence by treating physician.
- Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer.
- Adequately treated carcinoma in situ without current evidence of disease.
- people for whom the goal of therapy is tumor debulking before stem cell transplant.
- people who are deemed by the treating physician to be unfit to tolerate the R-CHOP regimen.
- Any history of central nervous system (CNS) lymphoma or leptomeningeal disease.
- Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP).
- Major surgical procedure within 28 days before first dose of study drug.
- Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac...
- Absolute neutrophil count (ANC) \<1.0 x 109/L or platelet count \<75 x 109/L; for people with disease involvement in the bone marrow, ANC \<0.75 x 109/L or platelet count \<50 x 109/L. people will only be considered...
- Total bilirubin \>1.5 x upper limit normal (ULN) unless other reason known; or aspartate aminotransferase (AST) or alanine transaminase (ALT) \>2.5 x ULN.
- Estimated creatinine clearance of \<30 mL/min, calculated using the formula of Cockcroft and Gault [(140-age) mass (kg)/(72 creatinine mg/dL) multiply by 0.85 if female].
- Prothrombin time/international normalized ratio (INR) or activated partial thromboplastin time (aPTT) (in the absence of a lupus anticoagulant) \>2.0 x ULN. Exception: people receiving a vitamin K antagonist are...
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease...
- Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other...
- Known history of infection with human immunodeficiency virus (HIV).
- Ongoing immunosuppressive therapy, including systemic corticosteroids within 2 weeks before the first dose of study drug.
- Known history of anaphylaxis or hypersensitivity to any study drug, or any of their components.
- Serologic status reflecting active hepatitis B or C infection.
- people who are anti-HBc positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result before the first dose of study drug. Those who are HbsAg positive or hepatitis B...
- people who are hepatitis C antibody positive will need to have a negative PCR result before the first dose of study drug. Those who are hepatitis C PCR positive will be excluded.
- Received a live virus vaccination within 28 days of first dose of study drug.
- History of stroke or intracranial hemorrhage within 6 months of first dose of study drug.
- History of bleeding diathesis.
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before first dose of study drug.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.
- Requires treatment with a strong CYP3A inhibitor/inducer.
- Concurrent participation in another therapeutic clinical trial.
- Active cytomegalovirus (CMV) infection (active viremia as evidenced by positive PCR result for CMV DNA).
- History of confirmed progressive multifocal leukoencephalopathy (PML).
- Pregnant or breastfeeding women.
The study team makes the final eligibility decision.
Where it's taking place
- A Coruña, Spain
- Alcorcón, Spain
- Badalona, Spain
- Barcelona, Spain
- Burgos, Spain
- Donostia / San Sebastian, Spain
- Gijón, Spain
- Madrid, Spain
- Majadahonda, Spain
- Málaga, Spain
- Palma de Mallorca, Spain
- Salamanca, Spain
- Santa Cruz de Tenerife, Spain
- Santander, Spain
- Seville, Spain
- Valencia, Spain
- Vigo, Spain
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include A Coruña, Spain; Alcorcón, Spain; Badalona, Spain; Barcelona, Spain; Burgos, Spain; Donostia / San Sebastian, Spain and 11 more location(s). 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.