Active, not recruitingNCT04626791Updated Aug 25, 2026Results posted

Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma

A Phase 2 interventional study of Acalabrutinib and Bortezomib in Mantle Cell Lymphoma, sponsored by Academic and Community Cancer Research United. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Academic and Community Cancer Research United · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 41
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study summary

This phase II trial investigates how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma. Modified VR-CAP is a combination of drugs used as standard first line treatment for mantle cell lymphoma. Chemotherapy drugs, such as bortezomib, cyclophosphamide, doxorubicin hydrochloride, and cytarabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that binds and depletes malignant B cells, by inducing immune responses and direct toxicity. Acalabrutinib blocks a key enzyme which is needed for malignant cell growth in mantle cell lymphoma. Combining modified VR-CAP and acalabrutinib as first line therapy may be more useful against mantle cell lymphoma compared to the usual treatment.

Read the detailed description

PRIMARY OBJECTIVE:

I. To determine the proportion of complete metabolic responses according to Lugano criteria at the end of study therapy.

SECONDARY OBJECTIVES:

I. To evaluate the safety of this regimen. II. To determine the proportion of subjects proceeding to autologous stem cell transplant (ASCT).

III. To determine the feasibility and results of stem cell mobilization and successful collection.

IV. To determine the progression-free survival (PFS) and overall survival (OS) (event monitoring phase), assessed up to 2 years after registration.

CORRELATIVE RESEARCH OBJECTIVE:

I. To assess minimal residual disease level after 3 and 6 cycles of therapy using the ClonoSEQ (Adaptive Biotechnologies, Seattle, Washington [WA]), and to explore the relationship between radiographic complete response (CR) rate and baseline features.

OUTLINE:

CYCLES 1, 3, AND 5: Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-21. Patients also receive bortezomib subcutaneously (SC) on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) intravenously (IV), cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5.

CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2.

Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for up to 2 years after registration.

Conditions studied

Mantle Cell Lymphoma

Browse trials for

Lymphoma, Mantle-Cell 783

In context

Lymphoma, Mantle-Cell

783 studies on the registry are indexed under Lymphoma, Mantle-Cell; 146 are open to participants now.

This study's enrollment of 41 is close to the median of 39 across 699 interventional studies indexed under Lymphoma, Mantle-Cell.

Browse Lymphoma, Mantle-Cell studies →

Lead sponsor

Academic and Community Cancer Research United is the lead sponsor of 49 studies on the registry; 5 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age 18-75 years
No prior therapy for mantle cell lymphoma (MCL)
MCL in need of systemic therapy, and potentially eligible for ASCT as assessed by the treating physician
Documented histological confirmation of MCL by local institutional review
Documented, fludeoxyglucose F-18 (FDG)-avid measurable disease (at least 1 lesion >= 1.5 cm in diameter) as detected by positron emission tomography (PET)/computed tomography (CT) and as defined and includes measurable nodal and extranodal disease sites, or splenomegaly measuring more than 13 cm in vertical length
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
Absolute neutrophil count (ANC) >= 1000/mm\^3 or >= 500/mm\^3 if due to lymphomatous marrow or spleen involvement (obtained =\< 30 days prior to registration)
Platelet count >= 100,000/mm\^3 or >= 75,000/mm\^3 if due to lymphomatous marrow or spleen involvement (obtained =\< 30 days prior to registration)
Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which total bilirubin =\< 3 x upper limit of normal [ULN] is permitted) (obtained =\< 30 days prior to registration)
Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 30 days prior to registration)
Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) =\< 2 x ULN, unless elevated due to a lupus anticoagulant (obtained =\< 30 days prior to registration)
Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula (obtained =\< 30 days prior to registration)
Negative pregnancy test done within =\< 14 days prior to registration for women of childbearing potential only
For women of childbearing potential (WOCBP, defined as premenopausal women capable of becoming pregnant): Must agree to use of highly effective method of birth control during study therapy and until 12 months after last dose of study therapy. NOTE: 'Acceptable' methods are not adequate. Highly effective methods are defined by Clinical Trials Facilitation and Coordination Group [CTFG] as having a failure rate of \< 1% per year
Men must agree to use barrier contraception starting with the first dose of study therapy and through 180 days after completion of study therapy
Provide informed written consent
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
Hematologic labs must be obtained within =\< 14 days of registration
Willing and able to participate in all required evaluations and procedures in this study protocol
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information

Exclusion criteria

Exclusion Criteria:

Prior systemic treatment for mantle cell lymphoma. Short course of steroids (=\< 7 days) for symptom management or localized radiation is permissible, as long as measurable disease outside of the radiation field exists
Peripheral neuropathy or neuropathic pain of grade 2 or worse as assessed by the investigator
Prior exposure to bortezomib or a BTK inhibitor
Prior anthracycline exposure unless cumulative prior exposure is under 150 mg per square meter
Requiring anticoagulation with warfarin or equivalent vitamin k antagonist
Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura)
Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease)
History of stroke or intracranial hemorrhage within 6 months prior to enrollment
Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer
Requiring treatment with a proton pump inhibitor. Examples include: dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, or therapeutic class equivalents
- Note: H2-receptor agonists are not exclusionary
History of allergic reactions attributed to acalabrutinib, cytarabine, bortezomib, boron, or any of the other agents administered as part of the therapeutic regimen in this study
Active systemic fungal, bacterial, viral, or other infection that is worsening (defined as increasing signs/symptoms of infection during screening) or, requires intravenous antibiotic therapy
Active or chronic uncontrolled hepatitis B or hepatitis C infection. Patients with positive hepatitis B core antibody positive require negative polymerase chain reaction (PCR) prior to enrollment. Hepatitis B surface antigen positive or PCR positive patients will be excluded. Patients with hepatitis C must have negative hepatitis C virus (HCV) ribonucleic acid (RNA) for inclusion
Co-morbid systemic illnesses or other severe concurrent disease (including major surgery within 2 weeks) which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Known to be human immunodeficiency virus (HIV) positive since antiretroviral therapy has a potential for drug interactions with acalabrutinib
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure or low cardiac ejection fraction (New York Heart Association [NYHA] class 3-4 or ejection fraction [EF] \< 45%), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy =\< 2 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer localized prostate cancer, or carcinoma-in-situ of the breast or cervix. NOTE: If there is a history or prior malignancy, patients must not be receiving other specific treatment for their cancer
Pregnant and/or breastfeeding
Has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication
Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening. unless directly due to MCL Involvement by endoscopic or histologic evaluation
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
Concurrent participation in another therapeutic clinical trial

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 41 participants (actual)

Study arms

Experimental
Treatment (modified VR-CAP, acalabrutinib)
CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Acalabrutinib · Drug: Bortezomib · Drug: Cyclophosphamide · Drug: Cytarabine · Drug: Doxorubicin Hydrochloride · Drug: Prednisone · Biological: Rituximab · Biological: Rituximab and Hyaluronidase Human

Interventions

DrugAcalabrutinib
Given PO
Also known as: ACP-196, Bruton Tyrosine Kinase Inhibitor ACP-196
DrugBortezomib
Given SC
Also known as: [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade
DrugCyclophosphamide
Given IV
Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
DrugCytarabine
Given IV
Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453
DrugDoxorubicin Hydrochloride
Given IV
Also known as: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, Rubex
DrugPrednisone
Given PO
Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone
BiologicalRituximab
Given IV
Also known as: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Riabni, Rituxan, Rituximab ABBS, Rituximab ARRX, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, Rituximab PVVR, rituximab-abbs, Rituximab-arrx, Rituximab-pvvr, RTXM83, Ruxience, Truxima
BiologicalRituximab and Hyaluronidase Human
Given IV
Also known as: Rituxan Hycela, Rituximab Plus Hyaluronidase, Rituximab/Hyaluronidase, Rituximab/Hyaluronidase Human

What researchers measure

Primary outcomes

Percentage of Complete Responses to Therapy (Complete Metabolic Response [CMR])
Measured according to Lugano criteria. A success is defined as a CMR as the objective status at the end of treatment. The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Time frame: 29 months

Secondary outcomes

Number of Patients Experiencing at Least One Grade 3 or Greater Adverse Event
The number of patients experiencing at least one grade 3 or greater adverse event will be reported.
Time frame: 29 months
Progression-free Survival
The proportion of patients alive and progression free with 95% CI will be estimated using the method of Kaplan-Meier.
Time frame: 15 months
Overall Survival
The proportion of participants alive and 95% CI will be estimated using the method of Kaplan-Meier.
Time frame: 18 months
Feasibility of Stem Cell Collection
The percentage of patients successfully collecting at least 2 x 10\^6 CD34 cells/kg pt body weight will be calculated and reported.
Time frame: 29 months
Successful Proceeding to Autologous Stem Cell Transplant (ASCT)
The feasibility of stem cell collection will be determined by the proportion of patients successfully collecting at least 2 x 10\^6 CD34 cells/kg pt body weight divided by the total number of evaluable patients proceeding to ASCT.
Time frame: 29 months

Other outcomes

MRD Rate
Measured by sequencing. MRD results will be reported descriptively, and explored for correlation with clinical factors and patient outcomes.
Time frame: Up to completion of study treatment
Minimal Residual Disease (MRD) Rate
Measured by flow. MRD results will be reported descriptively, and explored for correlation with clinical factors and patient outcomes.
Time frame: Up to completion of study treatment

Results

Posted Jul 22, 2026

Participant flow

Participant flow — Overall Study
Milestone	Treatment (Modified VR-CAP, Acalabrutinib)
Started	41
Completed	39
Not completed	2
Withdrew: Adverse event	2

Outcome measures

PrimaryPercentage of Complete Responses to Therapy (Complete Metabolic Response [CMR])

Measured according to Lugano criteria. A success is defined as a CMR as the objective status at the end of treatment. The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Time frame:: 29 months
Reported as:: Number · percentage of participants

Percentage of Complete Responses to Therapy (Complete Metabolic Response [CMR])
percentage of participants	Treatment (Modified VR-CAP, Acalabrutinib)
Percentage of Complete Responses to Therapy (Complete Metabolic Response [CMR])	90.2 (83.3 to 99.1)

SecondaryNumber of Patients Experiencing at Least One Grade 3 or Greater Adverse Event

The number of patients experiencing at least one grade 3 or greater adverse event will be reported.

Time frame:: 29 months
Reported as:: Count of participants · Participants

Number of Patients Experiencing at Least One Grade 3 or Greater Adverse Event
Participants	Treatment (Modified VR-CAP, Acalabrutinib)
Number of Patients Experiencing at Least One Grade 3 or Greater Adverse Event	33

SecondaryProgression-free Survival

The proportion of patients alive and progression free with 95% CI will be estimated using the method of Kaplan-Meier.

Time frame:: 15 months
Reported as:: Number · percentage of participants

Progression-free Survival
percentage of participants	Treatment (Modified VR-CAP, Acalabrutinib)
Progression-free Survival	87.5 (75.2 to 100)

SecondaryOverall Survival

The proportion of participants alive and 95% CI will be estimated using the method of Kaplan-Meier.

Time frame:: 18 months
Reported as:: Number · percentage of participants

Overall Survival
percentage of participants	Treatment (Modified VR-CAP, Acalabrutinib)
Overall Survival	95.8 (88.1 to 100)

SecondaryFeasibility of Stem Cell Collection

The percentage of patients successfully collecting at least 2 x 10\^6 CD34 cells/kg pt body weight will be calculated and reported.

Time frame:: 29 months
Reported as:: Count of participants · Participants

Feasibility of Stem Cell Collection
Participants	Treatment (Modified VR-CAP, Acalabrutinib)
Feasibility of Stem Cell Collection	9

SecondarySuccessful Proceeding to Autologous Stem Cell Transplant (ASCT)

The feasibility of stem cell collection will be determined by the proportion of patients successfully collecting at least 2 x 10\^6 CD34 cells/kg pt body weight divided by the total number of evaluable patients proceeding to ASCT.

Time frame:: 29 months
Reported as:: Count of participants · Participants

Successful Proceeding to Autologous Stem Cell Transplant (ASCT)
Participants	Treatment (Modified VR-CAP, Acalabrutinib)
Successful Proceeding to Autologous Stem Cell Transplant (ASCT)	9

Other pre-specifiedMRD Rate

Measured by sequencing. MRD results will be reported descriptively, and explored for correlation with clinical factors and patient outcomes.

Time frame:: Up to completion of study treatment

Results for this outcome have not been posted.

Other pre-specifiedMinimal Residual Disease (MRD) Rate

Measured by flow. MRD results will be reported descriptively, and explored for correlation with clinical factors and patient outcomes.

Time frame:: Up to completion of study treatment

Results for this outcome have not been posted.

Adverse events

Collected over 29 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment (Modified VR-CAP, Acalabrutinib)	2/41 (4.9%)	7/41 (17.1%)	41/41 (100%)

Most frequent serious events

Showing 10 of 15

Most frequent serious events
Event	Treatment (Modified VR-CAP, Acalabrutinib)
Febrile neutropeniaBlood and lymphatic system disorders	4/41
AnemiaBlood and lymphatic system disorders	1/41
Blood and lymph sys disorders - Oth SpecBlood and lymphatic system disorders	1/41
Atrial fibrillationCardiac disorders	1/41
Cardiac arrestCardiac disorders	1/41
Gastric hemorrhageGastrointestinal disorders	1/41
Small intestinal obstructionGastrointestinal disorders	1/41
Lung infectionInfections and infestations	1/41
SepsisInfections and infestations	1/41
Platelet count decreasedInvestigations	1/41

Most frequent other events

Showing 10 of 59

Most frequent other events
Event	Treatment (Modified VR-CAP, Acalabrutinib)
Platelet count decreasedInvestigations	29/41
Infusion related reactionInjury, poisoning and procedural complications	22/41
AnemiaBlood and lymphatic system disorders	16/41
Neutrophil count decreasedInvestigations	14/41
NauseaGastrointestinal disorders	8/41
Peripheral sensory neuropathyNervous system disorders	8/41
HeadacheNervous system disorders	7/41
Infections and infestations - Oth specInfections and infestations	5/41
VomitingGastrointestinal disorders	4/41
ThrushInfections and infestations	4/41

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Treatment (Modified VR-CAP, Acalabrutinib)
Mean	60.9 ± 7.50

Sex: Female, Male
Sex: Female, Male(Participants)	Treatment (Modified VR-CAP, Acalabrutinib)
Female	9
Male	32

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Treatment (Modified VR-CAP, Acalabrutinib)
Hispanic or Latino	4
Not Hispanic or Latino	35
Unknown or Not Reported	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Treatment (Modified VR-CAP, Acalabrutinib)
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	1
Black or African American	3
White	35
More than one race	0
Unknown or Not Reported	1

Region of Enrollment
Region of Enrollment(participants)	Treatment (Modified VR-CAP, Acalabrutinib)
United States	41

ECOG Performance Status
ECOG Performance Status(Participants)	Treatment (Modified VR-CAP, Acalabrutinib)
0	20
1	20
2	1

Study locations

3 sites

Mount Sinai Hospital
New York, New York 10029, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203, United States
University of Washington Medical Center - Montlake
Seattle, Washington 98195, United States

References and documents

Publications

Smith SD, Sundaram S, Giri S, Ness A, Wang Y, Gopal AK, Pang Y, Tatoian ET, Grossfeld T, Lynch RC, Warren EH, Nowakowski GS, Park SI. Outcomes From the Multicenter ACCRU-LY-1804/CARiBOU TRIAL (Cytarabine, Acalabrutinib and Rituximab Integrated With Bortezomib-Based Outpatient Therapy) in 1st Line Mantle Cell Lymphoma. Am J Hematol. 2026 Sep;101(9):2190-2196. doi: 10.1002/ajh.70406. Epub 2026 Jun 17. PubMed 42305039 ↗

Study documents

Protocol and statistical analysis plan · Oct 23, 2023

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04626791
Lead sponsor: Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Nov 13, 2020
Start date: Aug 3, 2021
Primary completion: Aug 3, 2025
Completion: Aug 3, 2028 (estimated)
Results posted: Jul 22, 2026
Last update: Aug 25, 2026

Study contacts

Stephen D Smith

principal investigator · Academic and Community Cancer Research United

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lymphoma, Mantle-Cell→

Other studies from this sponsor

Academic and Community Cancer Research United

Start the discussion