Status:
ACTIVE_NOT_RECRUITING
Acalabrutinib and Rituximab in Elderly Patients With Untreated Mantle Cell Lymphoma
Lead Sponsor:
Nordic Lymphoma Group
Collaborating Sponsors:
AstraZeneca
Conditions:
MCL
Mantle Cell Lymphoma
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
This is a phase II trial, with the aim of developing a chemotherapy-free regimen for untreated patients with mantle cell lymphoma (MCL). Acalabrutinib (ACP-196) is a next generation bruton tyrosine k...
Eligibility Criteria
Inclusion
- Age ≥60 years
- Pathologically confirmed MCL (according to the 2016 WHO classification), with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1
- Stage II-IV, measurable by imaging and requiring treatment in the opinion of the treating clinician
- No previous treatment for MCL (other than localised radiotherapy or 7-day pulse of steroids for symptom control)
- ECOG performance status 0 - 2
- Absolute neutrophil count (ANC) \> 1.0 x 109 and platelet count \>100 x 109, unless related to lymphoma - in this situation, the threshold for inclusion is ANC \> 0.5 x 109 and platelet count \> 50 x 109
- Creatinine clearance \> 30 ml/min (Cockcroft-Gault)
- AST and/or ALT \<3xULN and/or total bilirubin \<3xULN
- Able to give voluntary written informed consent
- Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for 2 days after the last dose of acalabrutinib or for 12 months after last dose of rituximab, whichever is longer
Exclusion
- Patients considered fit enough to undergo autologous or allogeneic stem cell transplant for MCL
- Major surgery within two weeks prior to day 1 of cycle 1
- Patients who are unable to swallow capsules, or who have disease significantly affecting gastrointestinal function that would limit oral absorption of medication
- Known serological positivity for HBV, HCV, HIV. Patients who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Patients who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded
- Diagnosed with or treated for any other malignancy than MCL within 2 years prior to day 1 of cycle 1 (except basal cell carcinoma, cutaneous squamous cell carcinoma or any other in situ malignancy)
- Active infection requiring treatment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Concurrent treatment with another investigational agent outside of this protocol
- Known history of drug-specific hypersensitivity or anaphylaxis to rituximab or acalabrutinib (including active product or excipient components).
- Active bleeding, history of bleeding diathesis (eg, hemophilia or von Willebrand disease)
- Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura)
- The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug
- Prothrombin time/INR or aPTT (in the absence of Lupus anticoagulant) \> 2x ULN
- Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Patients receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study
- History of significant cerebrovascular disease or event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug
- Breastfeeding or pregnant women
- Concurrent participation in another therapeutic clinical trial
- History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)
- Significant cardiovascular disease such as 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 at Screening. Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study
- Received a live virus vaccination within 28 days of first dose of study drug
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT05214183
Start Date
December 15 2021
End Date
January 1 2027
Last Update
February 12 2024
Active Locations (20)
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1
Department of Hematology X, Odense University Hospital
Odense, Denmark
2
Department of Hematology, Zeeland University Hospital Roskilde
Roskilde, Denmark
3
Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center
Helsinki, Finland
4
Oulu University Hospital
Oulu, Finland