Actively Recruiting
Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma
Led by University Health Network, Toronto · Updated on 2025-02-18
105
Participants Needed
5
Research Sites
582 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, non-randomized, phase II clinical trial conducted in Canada. The purpose of the study is to determine the remission rate of acalabrutinib in combination with R-CHOP in patients with previously untreated mantle cell lymphoma prior to autologous stem cell transplantation. This study is composed of 2 cohorts, A and B. In Cohort A all patients will receive six cycles of R-CHOP chemotherapy together with continuous acalabrutinib at the standard dose twice per day orally. All patients will undergo response assessment at the end of six cycles of R-CHOP + acalabrutinib with CT scan, PET/CT scan, and bone marrow biopsy. Responding patients will proceed with stem cell mobilization, apheresis, and processing. Following ASCT, patients will receive standard maintenance rituximab every 3 months for 2 years. Enrollment for Cohort A component of the study has been completed. Cohort B, involves using acalabrutinib with R-CHOP (same as Group A) but without an autologous stem cell transplant (ASCT) as part of the regimen. The study doctors hope to evaluate how participants respond to the treatment in terms of the time between treatment initiation and time when stable disease is achieved. The enrollment for cohort B is currently ongoing.
CONDITIONS
Official Title
Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older eligible for full-dose R-CHOP and autologous stem cell transplant (Cohort A) or aged 18 to 70 years eligible for full-dose R-CHOP (Cohort B)
- Histologic diagnosis of mantle cell lymphoma according to WHO classification
- Previously untreated mantle cell lymphoma with exceptions for prior localized radiotherapy, short-term corticosteroids, or limited chemotherapy doses as specified
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Presence of at least one measurable nodal mass (≥1.5 cm) or extranodal mass (≥1.0 cm) by imaging
- Women of childbearing potential must use highly effective contraception during treatment and for specified times after last dose; men must use effective contraception or abstain as specified
- Willing and able to participate in all required evaluations and procedures, including swallowing capsules or tablets
- Ability to understand the study and provide informed consent
You will not qualify if you...
- Secondary central nervous system involvement
- Prior exposure to BCR inhibitors (e.g., BTK inhibitors), BCL-2 inhibitors, or similar
- Prior malignancy requiring active treatment except certain treated skin, cervical, or prostate cancers or those disease-free for 3 or more years
- Clinically significant cardiovascular disease or recent myocardial infarction within 6 months (except controlled atrial fibrillation)
- Difficulty swallowing oral medication or gastrointestinal conditions limiting absorption
- Known HIV infection or significant active infections including progressive multifocal leukoencephalopathy
- Known hypersensitivity or anaphylaxis to study drugs or components
- Active bleeding disorders or uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
- Use of strong CYP3A4 inhibitors/inducers that cannot be modified or inability to adjust acalabrutinib dose
- Use of warfarin or equivalent anticoagulants
- Use of proton pump inhibitors unless switched to alternatives
- Recent significant cerebrovascular disease or major surgery within specified timeframes
- Recent live virus vaccination within 28 days
- Positive hepatitis B or C PCR test results or active infection
- Low blood counts below specified thresholds unless due to lymphoma involvement
- Abnormal liver or kidney function tests beyond specified limits
- Pregnancy or breastfeeding
- Concurrent participation in another therapeutic clinical trial
- Severe or uncontrolled systemic diseases or conditions that could affect study participation or safety
- Recent investigational drug use
- Life-threatening illness or organ dysfunction compromising safety or study risk
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Trial Site Locations
Total: 5 locations
1
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
2
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
3
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Actively Recruiting
4
Sunnybrook Research Institute
Toronto, Ontario, Canada
Active, Not Recruiting
5
Centre Hospitalier Universitaire de Québec
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
Research Team
J
John Kuruvilla, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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