Mantle Cell LymphomaPhase 2NCT04402138
Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma
A Phase 2 study testing Acalabrutinib in people with Mantle Cell Lymphoma, run by SCRI Development Innovations, LLC at 4 sites in United States.
Trial summary
This is a phase II study to evaluate efficacy of Acalabrutinib as a maintenance therapy following blood or marrow transplant (BMT) in patients who have been diagnosed with mantle cell lymphoma. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Aug 2020to 5 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must meet all of the following criteria in order to be included in this research study:
- Written informed consent, according to local guidelines, signed by the subject or by a legal guardian prior to the performance of any study-related screening procedures.
- Men and women ≥18 years-of-age at the time of signature of the informed consent form (ICF).
- A diagnosis of MCL confirmed by one of the following:
- t(11;14) detected by fluorescence in situ hybridization (FISH), conventional cytogenetics, or other molecular evaluation
- expression of cyclin D1 confirmed by immunohistochemistry.
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- Subject must have completed induction chemotherapy and plan to and be eligible to receive their first BMT per standard of care.
- Availability of an archival paraffin-embedded tumor block for MRD testing.
- The Investigator anticipates that the subject will meet the appropriate lab requirements listed in Screening #2 by Day 100.
- Patients who received prior therapy with a BTK inhibitor are eligible to enroll.
- Inclusion Criteria Post-BMT, Prior to Day 100 (Screening #2):
- Adequate organ system function defined as:
- Absolute neutrophil count (ANC) ≥1,000/mm3.
- Total bilirubin ≤1.5 x the upper limit of normal (ULN) (except for previously documented Gilbert's syndrome)
- Platelet count ≥75,000/mm3. Platelet infusions to meet eligibility criteria are not allowed within 3 days of study enrollment.
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 x ULN
- Calculated creatinine clearance (CrCl) ≥30 mL/min as calculated by the CockcroftGault method. Estimated CrCl (glomerular filtration rate [GFR]) = (140-age [years]) x (weight [kg]) x Fa /(72 x serum creatinine [mg/dL]) a where F = 0.85 for females and F = 1 for males
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Subjects who did not receive an anti-cancer therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) during the time between their transplant and the start of study therapy. Subjects must have recovered (e.g., Grade ≤1 or baseline) from AEs associated with prior cancer therapy. Note: Subjects with Grade ≤2 neuropathy or Grade ≤2 alopecia are an exception to the latter criterion and may qualify for the study.
- Woman of childbearing potential (WoCBP) who are sexually active with male partners must use highly effective methods of contraception during treatment and for 2 days after the last dose of acalabrutinib. For male subjects with a pregnant or non-pregnant WoCBP partner, no contraception measures are required. A WoCBP must have a negative pregnancy test (urine or serum) at the time of screening and 72 hours before starting the study drug or have evidence of non-childbearing potential by fulfilling one of the following criteria:
- Post-menopausal women, defined as either women aged >50 years and amenorrheic for ≥12 months following cessation of all exogenous hormonal treatments or women <50 years old who have been amenorrheic for ≥12 months following the cessation of exogenous hormonal treatments, and have serum follicle- stimulating hormone (FSH) and luteinizing hormone (LH) levels in the post- menopausal range for the institution.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation
- Medically confirmed, irreversible premature ovarian failure.
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules 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 (PHI).
Who cannot join
- Patients who meet any of the following criteria will be excluded from study entry:
- Subjects who have relapsed or progressed at any time prior to BM
- Subjects with known mutations that confer resistance to a BTK inhibitor.
- Confirmed clinical PD since the time of BMT
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥2 years or that will not limit survival to <2 years. The exceptions are:
- Subjects treated with curative intent >2 years prior to enrollment and have a low probability of recurrence.
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- 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.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
- Known history of infection with human immunodeficiency virus (HIV) or any uncontrolled active systemic bacterial, fungal, parasitic or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection progression are present.
- Known history of drug-specific hypersensitivity or anaphylaxis to study drug (including active product or excipient components).
- Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura.
- Requires treatment with a strong CYP3A4 inhibitor/inducer
- Requires or is receiving anticoagulation treatment with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of study drug.
- Prothrombin time (PT)/ international normalized ratio (INR) or activated partial thromboplastin time (aPTT) >2 x ULN (in the absence of lupus anticoagulant).
- Requires treatment with proton-pump inhibitors (e.g., 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 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 first dose of study drug.
- Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HbsAg) negative will need to have a negative PCR result. Those who are 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.
- Breastfeeding or pregnant.
- Concurrent participation in another therapeutic clinical trial.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
- The inability to swallow capsules.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Colorado Blood Cancer Institute
Denver, Colorado, 80218
HCA Midwest
Kansas City, Missouri, 64132
Tennessee Oncology
Nashville, Tennessee, 37203
Tulane University, Office of Clinical Research
New Orleans, Louisiana, 70112
About this study
Official title: Single Arm, Phase II Study of Acalabrutinib as Post-Autologous Blood or Marrow Transplant (BMT) Maintenance Therapy in Subjects With Mantle Cell Lymphoma
This is a phase II study to evaluate efficacy of Acalabrutinib as a maintenance therapy following blood or marrow transplant (BMT) in patients who have been diagnosed with mantle cell lymphoma.
Read the detailed description
Mantle cell lymphoma (MCL) is one of approximately 100 different types of non-Hodgkin's lymphoma (NHL). Due to the aggressive and heterogeneous nature of MCL, majority of patients are diagnosed with advanced stage disease that requires immediate, diverse and aggressive courses of therapy to improve the outcome of the disease. The addition of blood or bone marrow transplantation (BMT) to the chemotherapy regimens is a critical factor to prolong duration of response in patients, however, the benefit of combination chemotherapy followed by BMT is often temporary as patients experience disease progression and mortality and this underscores the need for novel therapies as well as additional maintenance therapy strategies to prevent relapse post-BMT.
Acalabrutinib, a selective, irreversible small molecule inhibitor of Bruton's tyrosine kinase (BTK) is approved for the treatment of adult patients with MCL who have received at least 1 prior therapy
This study is a single arm, multi-center, phase 2 study of participants who will receive acalabrutinib as maintenance therapy post-BMT. Participants will undergo a standard of care BMT with conditioning regimen determined by the treating physician per institutional guidelines.The BMT procedure is not considered part of this study. Following completion of the BMT, maintenance therapy with acalabrutinib will begin on Day 100 in 28-day cycles. Participants will self-administer 129 mg acalabrutinib twice daily (BID) until they reach 2 years post-BMT (approximately 22 cycles). Participants will be followed for up to 5 years post-BMT for Progression Free Survival.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Acalabrutinib
- Keywords
- Acalabrutinib, Non Hodgkin's lymphoma, Blood or Marrow transplant, BMT, Maintenance therapy, Bruton's Tyrosine Kinase Inhibitor
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcalabrutinibDrug
Also called Calquence
Acalabrutinib 129 mg will be self-administered orally twice daily (BID) starting from 100 day (+/- 7 days) Post-BMT on a 28-day schedule, with or without food, until the patient has reached approximately 2 years post-BMT.
| Study group | Role | What they receive |
|---|---|---|
| Acalabrutinib | Experimental | Acalabrutinib will be self-administered orally for up to approximately 2 years post-BMT. Receives: Drug: Acalabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival Rate (PFS) at 2 Years Post-Blood or Marrow Transplant (BMT)
Progression Free Survival Rate is defined as the Kaplan-Meier estimate of the percentage of participants who are alive and free of disease progression according to Response Evaluation Criteria in Lymphoma (RECIL 2017) for up to 2 years post-BMT.
According to RECIL, disease progression is defined as following criteria: >20% increase in sum of longest diameters of target lesions, for small lymph nodes measuring <15 mm post therapy, a minimum absolute increase of 5 mm and the longest diameter should exceed 15mm, or appearance of new lesions.
Measured: 2 years after date of BMT procedure for each patient
Secondary outcomes (3)
Conversion Rate From Minimal Residual Disease Positive (MRD+) to Minimal Residual Disease Negative (MRD-)
Percentage of participants whose whole blood or bone marrow results transition from MRD positive before study treatment to MRD negative at 2 years post-BMT. An MRD negative status will be defined as all results from whole blood and bone marrow that are negative for the presence of residual clonal cells (with assay sensitivity of 10^-6) per Adaptive Biotechnologies' reporting methods.
Measured: Assessed at day 100 post-BMT procedure (prior to beginning maintenance treatment with study drug) and 2 years post-BMT
Minimal Residual Disease (MRD) Correlation With Progression Free Survival (PFS)
To compare the Kaplan-Meier estimated PFS rate for MRD negative population with MRD positive population. Progression-free survival is defined as the time from date of BMT procedure (day 0) until the date of objective radiological PD according to Response Evaluation Criteria in Lymphoma (RECIL 2017) or death. According to RECIL, disease progression is defined as following criteria: >20% increase in sum of longest diameters of target lesions, for small lymph nodes measuring <15 mm post therapy, a minimum absolute increase of 5 mm and the longest diameter should exceed 15mm, or appearance of new lesions. An MRD negative status will be defined as all results from whole blood and bone marrow that are negative for the presence of residual clonal cells (with assay sensitivity of 10^-6) per Adaptive Biotechnologies' reporting methods.
Measured: 2 years after date of BMT procedure for each patient
Incidence of Grade 3 or Greater Treatment-Related Adverse Events
Number of participants with grade 3 or higher CTCAE Version 5.0 Adverse Events that are considered related to study drug
Measured: Safety assessment will be done every cycle up to 2 years post-BMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start7 Aug 2020
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Acerta Pharma, LLC
- Responsible party
- Sponsor
- Investigators
- Michael Tees, MD, Study chair, Colorado Blood Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402138
- Sponsor's protocol ID
- LYM 155
- Status last verified
- May 2025
- First submitted
- 15 May 2020
- Last updated
- 13 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm, Phase II Study of Acalabrutinib as Post-Autologous Blood or Marrow Transplant (BMT) Maintenance Therapy in Subjects With Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04402138
- Acronym / sponsor ID
- LYM 155
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Acalabrutinib, Non Hodgkin's lymphoma, Blood or Marrow transplant, BMT, Maintenance therapy, Bruton's Tyrosine Kinase Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Acerta Pharma, LLC
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Posted 13 May 2025
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 phase II study to evaluate efficacy of Acalabrutinib as a maintenance therapy following blood or marrow transplant (BMT) in patients who have been diagnosed with mantle cell lymphoma.
Detailed description
Mantle cell lymphoma (MCL) is one of approximately 100 different types of non-Hodgkin's lymphoma (NHL). Due to the aggressive and heterogeneous nature of MCL, majority of patients are diagnosed with advanced stage disease that requires immediate, diverse and aggressive courses of therapy to improve the outcome of the disease. The addition of blood or bone marrow transplantation (BMT) to the chemotherapy regimens is a critical factor to prolong duration of response in patients, however, the benefit of combination chemotherapy followed by BMT is often temporary as patients experience disease progression and mortality and this underscores the need for novel therapies as well as additional maintenance therapy strategies to prevent relapse post-BMT.
Acalabrutinib, a selective, irreversible small molecule inhibitor of Bruton's tyrosine kinase (BTK) is approved for the treatment of adult patients with MCL who have received at least 1 prior therapy
This study is a single arm, multi-center, phase 2 study of participants who will receive acalabrutinib as maintenance therapy post-BMT. Participants will undergo a standard of care BMT with conditioning regimen determined by the treating physician per institutional guidelines.The BMT procedure is not considered part of this study. Following completion of the BMT, maintenance therapy with acalabrutinib will begin on Day 100 in 28-day cycles. Participants will self-administer 129 mg acalabrutinib twice daily (BID) until they reach 2 years post-BMT (approximately 22 cycles). Participants will be followed for up to 5 years post-BMT for Progression Free Survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acalabrutinib | Experimental | Drug: AcalabrutinibAcalabrutinib will be self-administered orally for up to approximately 2 years post-BMT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patients must meet all of the following criteria in order to be included in this research study:
- Written informed consent, according to local guidelines, signed by the subject or by a legal guardian prior to the performance of any study-related screening procedures.
- Men and women ≥18 years-of-age at the time of signature of the informed consent form (ICF).
- A diagnosis of MCL confirmed by one of the following:
- Subject must have completed induction chemotherapy and plan to and be eligible to receive their first BMT per standard of care.
Key exclusion criteria (23 listed)
- Subjects who have relapsed or progressed at any time prior to BM
- Subjects with known mutations that confer resistance to a BTK inhibitor.
- Confirmed clinical PD since the time of BMT
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥2 years or that will not limit survival to <2 years. The exceptions are:
- 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.
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 |
|---|---|---|
| AcalabrutinibAlso: CalquenceAcalabrutinib 129 mg will be self-administered orally twice daily (BID) starting from 100 day (+/- 7 days) Post-BMT on a 28-day schedule, with or without food, until the patient has reached approximately 2 years post-BMT. | Drug | Acalabrutinib |
Primary outcome
Progression Free Survival Rate (PFS) at 2 Years Post-Blood or Marrow Transplant (BMT)
Time frame: 2 years after date of BMT procedure for each patient
Progression Free Survival Rate is defined as the Kaplan-Meier estimate of the percentage of participants who are alive and free of disease progression according to Response Evaluation Criteria in Lymphoma (RECIL 2017) for up to 2 years post-BMT. According to RECIL, disease progression is defined as following criteria: >20% increase in sum of longest diameters of target lesions, for small lymph nodes measuring <15 mm post therapy, a minimum absolute increase of 5 mm and the longest diameter should exceed 15mm, or appearance of new lesions.
3 secondary outcomes
Conversion Rate From Minimal Residual Disease Positive (MRD+) to Minimal Residual Disease Negative (MRD-)
Time frame: Assessed at day 100 post-BMT procedure (prior to beginning maintenance treatment with study drug) and 2 years post-BMT
Minimal Residual Disease (MRD) Correlation With Progression Free Survival (PFS)
Time frame: 2 years after date of BMT procedure for each patient
Incidence of Grade 3 or Greater Treatment-Related Adverse Events
Time frame: Safety assessment will be done every cycle up to 2 years post-BMT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
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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.
Michael Tees, MD study chair
Colorado Blood Cancer Institute
4 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 in people with Mantle Cell Lymphoma, run by SCRI Development Innovations, LLC at 4 sites in United States.
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 25 inclusion and 23 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: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival Rate (PFS) at 2 Years Post-Blood or Marrow Transplant (BMT) (time frame: 2 years after date of BMT procedure for each patient). 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 13 May 2025.