Mantle Cell LymphomaPhase 2NCT04566887
Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma
A Phase 2 study testing Acalabrutinib and R-CHOP chemotherapy in people with Mantle Cell Lymphoma, run by University Health Network, Toronto at 5 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Acalabrutinib and R-CHOP chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Mar 2021to 30 Apr 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible subjects will be considered for inclusion in Cohort B of this study if they meet all of the following criteria:
- Men and women 18-70 years of age deemed eligible for treatment with full dose RCHOP by the qualified investigator.
- Histologic diagnosis of MCL according to the World Health Organization classification [Swerdlow, Blood 2016].
- Previously untreated MCL with the following exceptions: (a) prior radiotherapy for localized disease, (b) up to 7 days of corticosteroids (prednisone 100mg/day equivalent), (c) up to one dose of single-agent chemotherapy (for example, cyclophosphamide), (d) up to one cycle of R-CHOP if last R-CHOP is between 21 days and 2 months from start of R-CHOP+acalabrutinib. Other chemotherapy regimens (for example, bendamustine and rituximab) are not allowed. Patients with exceptions (c) and (d) are eligible as long as all other eligibility criteria are met AND at least a CT scan and bone marrow biopsy were performed prior to chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Presence of at least one radiologically measurable nodal or extranodal mass. A measurable nodal mass must have a longest diameter ≥1.5 cm. A measurable extranodal mass should have a longest diameter ≥1.0 cm.[Cheson, JCO 2014]
Show all 9Show fewer
- Women of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and up to 12 months after the last dose of rituximab or R-CHOP, or 2 days after the last dose of acalabrutinib, whichever is last administered. Examples of highly effective contraceptive methods include an agreement to remain abstinent (ie, refrain from heterosexual intercourse), bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Men who are sexually active must use highly effective methods of contraception during treatment and up to 6 months after the last dose of rituximab or R-CHOP, or 2 days after the last dose of acalabrutinib, whichever is last administered. Men require an agreement to remain abstinent (ie, refrain from heterosexual intercourse) or use a condom, and an agreement to refrain from donating sperm. Periodic abstinence and withdrawal are not acceptable methods of contraception. Fertility preservation options should be discussed.
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules or 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
Who cannot join
- Subjects will be ineligible for Cohort A of this study if they meet any of the following criteria:
- Secondary central nervous system involvement.
- Prior exposure to a BCR inhibitor (eg, BTK inhibitors, phosphoinositide-3 kinase (PI3K), or Syk inhibitors) or BCL-2 inhibitor.
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or prostate cancer, or other cancer from which the subject has been disease free for ≥ 3 years or which will not limit survival to < 5 years. Subjects receiving adjuvant hormonal therapy for early breast or prostate cancer are eligible.
- Clinically significant cardiovascular disease such as uncontrolled or 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. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study.
- Difficulty with or unable to swallow oral medication, or conditions significantly affecting gastrointestinal function that would limit absorption of oral medication.
Show all 54Show fewer
- Known history of infection with HIV or any significant active infection (eg, bacterial, viral or fungal), including suspected or confirmed progressive multifocal leukoencephalopathy.
- Known history of drug-specific hypersensitivity or anaphylaxis to study drugs (acalabrutinib and individual components of R-CHOP), including active product or excipient components.
- Active bleeding or history of bleeding diathesis (eg, hemophilia or von Willebrand disease).
- Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).
- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer which cannot be modified as described in Sections 3.8.2 and 3.9.2, and/or the dose of acalabrutinib cannot be modified as described in these sections.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, warfarin).
- Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.
- History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug.
- Major surgical procedure within 4 weeks 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.
- Received a live virus vaccination within 28 days of first dose of R-CHOP + acalabrutinib.
- Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (antiHBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result before enrolment and must be willing to undergo PCR testing during the study. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded.Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.
- ANC <1.0 x109/L (subjects with bone marrow involvement by lymphoma are eligible regardless of ANC)
- Platelets <50 x109/L (subjects with bone marrow involvement by lymphoma are eligible regardless of platelet count)
- Total serum bilirubin ≥1.5 times the upper limit of normal, unless directly attributable to Gilbert's syndrome (or >3 times for documented hepatic involvement by lymphoma), AST and ALT >3 times the upper limit of normal (or >5 times for documented hepatic involvement by lymphoma)
- Creatinine clearance <30 mL/min.
- PT/INR >2 times the upper limit of normal in the absence of anticoagulants and/or PTT >2 times the upper limit of normal in the absence of anticoagulants.
- Breastfeeding or pregnant. WOCBP must have a serum and/or urine pregnancy test done a maximum of 7 days prior to treatment initiation and a negative result must be documented prior to recruitment.
- Concurrent participation in another therapeutic clinical trial.
- Evidence of disease (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension and renal transplant) that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol.
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
- Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk.
- Cohort B:
- Subjects will be ineligible for Cohort B of this study if they meet any of the following criteria:
- Secondary central nervous system involvement.
- Prior exposure to a BCR inhibitor (eg, BTK inhibitors, phosphoinositide-3 kinase (PI3K), or Syk inhibitors) or BCL-2 inhibitor.
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or prostate cancer, or other cancer from which the subject has been disease free for ≥ 3 years or which will not limit survival to < 5 years. Subjects receiving adjuvant hormonal therapy for early breast or prostate cancer are eligible.
- Clinically significant cardiovascular disease such as uncontrolled or 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. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study.
- Difficulty with or unable to swallow oral medication, or conditions significantly affecting gastrointestinal function that would limit absorption of oral medication.
- Known history of infection with HIV or any significant active infection (eg, bacterial, viral or fungal), including suspected or confirmed progressive multifocal leukoencephalopathy.
- Known history of drug-specific hypersensitivity or anaphylaxis to study drugs (acalabrutinib and individual components of R-CHOP), including active product or excipient components.
- Active bleeding or history of bleeding diathesis (eg, hemophilia or von Willebrand disease).
- Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).
- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer which cannot be modified as described in Sections 3.8.2 and 3.9.2, and/or the dose of acalabrutinib cannot be modified as described in these sections.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, warfarin).
- History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug.
- Major surgical procedure within 4 weeks 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.
- Received a live virus vaccination within 28 days of first dose of R-CHOP + acalabrutinib.
- Hepatitis B or C serologic status: subjects 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 before enrolment and must be willing to undergo PCR testing during the study. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.
- ANC <1.0 x109/L (subjects with bone marrow involvement by lymphoma are eligible regardless of ANC)
- Platelets <50 x109/L (subjects with bone marrow involvement by lymphoma are eligible regardless of platelet count)
- Total serum bilirubin ≥1.5 times the upper limit of normal, unless directly attributable to Gilbert's syndrome (or >3 times for documented hepatic involvement by lymphoma), AST and ALT >3 times the upper limit of normal (or >5 times for documented hepatic involvement by lymphoma)
- Creatinine clearance <30 mL/min.
- PT/INR >2 times the upper limit of normal in the absence of anticoagulants and/or PTT >2 times the upper limit of normal in the absence of anticoagulants.
- Breastfeeding or pregnant. WOCBP must have a serum and/or urine pregnancy test done a maximum of 7 days prior to treatment initiation and a negative result must be documented prior to recruitment.
- Concurrent participation in another therapeutic clinical trial.
- Evidence of disease (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension and renal transplant) that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol.
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
- Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Centre Hospitalier Universitaire de Québec
Québec, Quebec, G1J 1Z4
Princess Margaret Cancer Centre
Toronto, Ontario
Sunnybrook Research Institute
Toronto, Ontario
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase II Study of Acalabrutinib in Combination With R-CHOP Chemotherapy in Previously Untreated Mantle Cell Lymphoma
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
- Mantle Cell Lymphoma
- Being tested
- Acalabrutinib, R-CHOP chemotherapy
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcalabrutinibDrug
Administered as 100mg tablets.
R-CHOP chemotherapyDrug
R-CHOP chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Acalabrutinib 100mg twice per day orally with standard of care R-CHOP chemotherapy by IV every 21 days for a maximum of six cycles. After 6 cycle of R-CHOP and study drug eligible participants will undergo ASCT. Receives: Drug: Acalabrutinib; Drug: R-CHOP chemotherapy |
| Cohort B | Experimental | Acalabrutinib 100mg twice per day orally with standard of care R-CHOP chemotherapy by IV every 21 days for a maximum of six cycles. Receives: Drug: Acalabrutinib; Drug: R-CHOP chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) rate by PET/CT scan using Lugano Classification for Malignant Lymphoma - Cohort A
Measured: 1-2 weeks after completing six cycles (21 days) of R-CHOP + acalabrutinib.
To evaluate FFS in patients receiving acalabrutinib + R-CHOP followed by 2 years of maintenance acalabrutinib + rituximab - Cohort B
Measured: 2-year failure-free survival (FFS), defined as time from treatment initiation to stable disease after at least 4 cycles of induction, relapse/progression at any time, or death from any cause
Secondary outcomes (9)
Adverse events of acalabrutinib and R-CHOP by using CTCAE version 5.0
Measured: Baseline through end of study treatment (up to 18 weeks)
Measures of efficacy by using the RECIL 2017 criteria.
Measured: Baseline to end of study (up to 2 years)
Rate of minimal residual disease negativity (MRD) prior to transplant by flow cytometry
Measured: Up to 18 weeks
Event-free in patients who discontinue acalabrutinib at the point of MRD negativity prior to transplant by flow cytometry
Measured: Baseline to end of study (up to 2 years)
Changes in scores of partient reported outcomes (PRO) as measured by FACT-Lym
Composed of the FACT-G plus the 15-item Lymphoma Subscale (LymS).
Measured: Baseline to end of study (up to 2 years)
Overall survival in patients who discontinue acalabrutinib at the point of MRD negativity
Measured: Baseline to end of study (up to 2 years)
Changes in scores of partient reported outcomes (PRO) as measured by FACT-Cog
Participants rated their cognitive function on a scale of 0 to 4 where 0 was never and 4 was several times a day.
Measured: Baseline to end of study (up to 2 years)
Changes in scores of partient reported outcomes (PRO) as measured by EORTC QLQ-C30
Participants rated their quality of life on a scale of 1 to 4 where 1 was not at all and 4 was very much.
Measured: Baseline to end of study (up to 2 years)
To evaluate event-free and overall survival in patients who achieve MRD negativity
Measured: Baseline to end of study (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Mar 2021
- Primary completionSep 2028 (estimated)
- Study completion30 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566887
- Sponsor's protocol ID
- OZM-109
- Other IDs
- 20-5858
- Status last verified
- Jun 2026
- First submitted
- 15 Sep 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Acalabrutinib in Combination With R-CHOP Chemotherapy in Previously Untreated Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04566887
- Acronym / sponsor ID
- OZM-109
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- 30 Apr 2032 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Acalabrutinib, Drug: R-CHOP chemotherapyAcalabrutinib 100mg twice per day orally with standard of care R-CHOP chemotherapy by IV every 21 days for a maximum of six cycles. After 6 cycle of R-CHOP and study drug eligible participants will undergo ASCT. |
| Cohort B | Experimental | Drug: Acalabrutinib, Drug: R-CHOP chemotherapyAcalabrutinib 100mg twice per day orally with standard of care R-CHOP chemotherapy by IV every 21 days for a maximum of six cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eligible subjects will be considered for inclusion in Cohort B of this study if they meet all of the following criteria:
- Men and women 18-70 years of age deemed eligible for treatment with full dose RCHOP by the qualified investigator.
- Histologic diagnosis of MCL according to the World Health Organization classification [Swerdlow, Blood 2016].
- Previously untreated MCL with the following exceptions: (a) prior radiotherapy for localized disease, (b) up to 7 days of corticosteroids (prednisone 100mg/day equivalent), (c) up to one dose of single-agent chemotherapy (for example, cyclophosphamide), (d) up to one cycle of R-CHOP if last R-CHOP is between 21 days and 2 months from start of R-CHOP+acalabrutinib. Other chemotherapy regimens (for example, bendamustine and rituximab) are not allowed. Patients with exceptions (c) and (d) are eligible as long as all other eligibility criteria are met AND at least a CT scan and bone marrow biopsy were performed prior to chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Key exclusion criteria (54 listed)
- Subjects will be ineligible for Cohort A of this study if they meet any of the following criteria:
- Secondary central nervous system involvement.
- Prior exposure to a BCR inhibitor (eg, BTK inhibitors, phosphoinositide-3 kinase (PI3K), or Syk inhibitors) or BCL-2 inhibitor.
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or prostate cancer, or other cancer from which the subject has been disease free for ≥ 3 years or which will not limit survival to < 5 years. Subjects receiving adjuvant hormonal therapy for early breast or prostate cancer are eligible.
- Clinically significant cardiovascular disease such as uncontrolled or 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. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcalabrutinibAdministered as 100mg tablets. | Drug | Cohort A, Cohort B |
| R-CHOP chemotherapyR-CHOP chemotherapy | Drug | Cohort A, Cohort B |
Primary outcome
Complete response (CR) rate by PET/CT scan using Lugano Classification for Malignant Lymphoma - Cohort A
Time frame: 1-2 weeks after completing six cycles (21 days) of R-CHOP + acalabrutinib.
To evaluate FFS in patients receiving acalabrutinib + R-CHOP followed by 2 years of maintenance acalabrutinib + rituximab - Cohort B
Time frame: 2-year failure-free survival (FFS), defined as time from treatment initiation to stable disease after at least 4 cycles of induction, relapse/progression at any time, or death from any cause
9 secondary outcomes
Adverse events of acalabrutinib and R-CHOP by using CTCAE version 5.0
Time frame: Baseline through end of study treatment (up to 18 weeks)
Measures of efficacy by using the RECIL 2017 criteria.
Time frame: Baseline to end of study (up to 2 years)
Rate of minimal residual disease negativity (MRD) prior to transplant by flow cytometry
Time frame: Up to 18 weeks
Event-free in patients who discontinue acalabrutinib at the point of MRD negativity prior to transplant by flow cytometry
Time frame: Baseline to end of study (up to 2 years)
Changes in scores of partient reported outcomes (PRO) as measured by FACT-Lym
Time frame: Baseline to end of study (up to 2 years)
Overall survival in patients who discontinue acalabrutinib at the point of MRD negativity
Time frame: Baseline to end of study (up to 2 years)
Changes in scores of partient reported outcomes (PRO) as measured by FACT-Cog
Time frame: Baseline to end of study (up to 2 years)
Changes in scores of partient reported outcomes (PRO) as measured by EORTC QLQ-C30
Time frame: Baseline to end of study (up to 2 years)
To evaluate event-free and overall survival in patients who achieve MRD negativity
Time frame: Baseline to end of study (up to 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Mantle Cell Lymphoma
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
RecruitingPhase 3
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Lymphoma
RecruitingPhase 1
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Lymphoma, Non-Hodgkin, B-cell Lymphoma
RecruitingPhase 2
Auto Stem Cell Transplant for Lymphoma Patients
Non-Hodgkin Lymphoma, Hodgkin Lymphoma
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acalabrutinib and R-CHOP chemotherapy in people with Mantle Cell Lymphoma, run by University Health Network, Toronto at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) rate by PET/CT scan using Lugano Classification for Malignant Lymphoma - Cohort A (time frame: 1-2 weeks after completing six cycles (21 days) of R-CHOP + acalabrutinib.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.