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Mantle Cell LymphomaPhase 2NCT03863184

Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL

A Phase 2 study testing Acalabrutinib, Lenalidomide and Rituximab in people with Mantle Cell Lymphoma, run by Weill Medical College of Cornell University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multi-arm phase 2 study to evaluate the preliminary evidence of efficacy and safety of the combination of acalabrutinib, lenalidomide and rituximab (ALR) and acalabrutinib, lenalidomide and obinutuzumab (ALO) in previously untreated 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, Lenalidomide and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
11 Oct 2019to 30 May 2028
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

  • Histologically confirmed diagnosis of mantle cell lymphoma
  • Age ≥ 18 years
  • No prior systemic therapy for lymphoma
  • Measurable disease defined by a tumor mass ≥ 1.5 cm in one dimension and measurable in two dimensions; measurable spleen disease is allowed
  • Treatment should be indicated according to the treating physician
  • ECOG performance status ≤ 2
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  • Required initial laboratory parameters:
  • Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
  • Platelet count ≥ 75,000 cells/mm3
  • Calculated creatinine clearance ≥ 30 ml/min by Cockcroft-Gault formula
  • Total bilirubin ≤ 2.0 x ULN
  • AST/SGOT and ALT/SGPT ≤ 3.0 x ULN
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use low molecular weight heparin).
  • All subjects must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of Revlimid REMS®.
  • Patients of reproductive potential agree to use birth control throughout their participation in this study, and for 28 days following study termination.
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days). FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before and continue for at least 28 days after the last dose of lenalidomide (or 2 days after the last dose of acalabrutinib, whichever is longer). FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual activity with a FCBP through one week post last dose even if they have had a successful vasectomy. Men must also agree to refrain from sperm donation during the same timeframe. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
  • Understand and voluntarily sign an ICF prior to any study related assessments and procedures are conducted.
  • Able to adhere to the study visit schedule and other protocol requirements.

Who cannot join

  • Patients with blastoid histology
  • Patients with known or suspected CNS involvement
  • Viral infection with HIV or hepatitis type B or C. Seropositive HBV patients are eligible if they are negative for HBV DNA by PCR and receive concomitant antiviral therapy during treatment and for additional six months after coming off study.
  • Prior history of malignancies other than MCL unless the patient has been disease free for ≥ 5 years from the signing of the ICF. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin; carcinoma in situ of cervix; carcinoma in situ of breast, or localized prostate cancer
  • Active uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
  • 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.
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  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or 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.
  • Active bleeding or history of bleeding diathesis (e.g., 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. Patients on moderate CYP3A inhibitors can be considered for study after a washout period of at least 7 days.
  • Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of study drug.
  • Prothrombin time (PT)/INR or aPTT (in the absence of lupus anticoagulant) >2x ULN.
  • 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.
  • Patients with a history of toxic epidermal necrolysis or Stevens-Johnson syndrome
  • Patients that are pregnant or breast feeding
  • Known hypersensitivity to any study drug or excipients
  • Patient on corticosteroids within two weeks prior to study entry, except for prednisone ≤ 20 mg/day or equivalent for purposes other than treating MCL
  • Use of any other experimental drug or therapy within 28 days of baseline
  • Patient at high risk for deep vein thrombosis not willing to take DVT prophylaxis
  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  • Known prior exposure to BTK inhibitor

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Multiple-center Phase 2 Study of Acalabrutinib-Lenalidomide-Rituximab (ALR) With an Expansion Cohort of Acalabrutinib-Lenalidomide-Obinutuzumab (ALO) in Patients With Previous Untreated Mantle Cell Lymphoma

This is a multi-arm phase 2 study to evaluate the preliminary evidence of efficacy and safety of the combination of acalabrutinib, lenalidomide and rituximab (ALR) and acalabrutinib, lenalidomide and obinutuzumab (ALO) in previously untreated mantle cell lymphoma. The study includes an induction phase consisting of 12 cycles of ALR or ALO. Responding subjects will be eligible to enter a maintenance phase. Subjects will continue maintenance ALR or ALO until disease progression, development of unacceptable toxicity, or voluntary withdrawal. Subjects will be followed after completing study intervention every 6 months for alternate anti-cancer therapy and survival.

Read the detailed description

This is a multi-arm phase 2 study to evaluate the preliminary evidence of efficacy and safety of the combination of acalabrutinib, lenalidomide and rituximab (ALR) and an expansion cohort of acalabrutinib, lenalidomide and obinutuzumab (ALO) in previously untreated mantle cell lymphoma.

The study includes an induction phase consisting of 12 cycles of ALR or ALO. Responding subjects will be eligible to enter a maintenance phase. Subjects will continue maintenance ALR or ALO until disease progression, development of unacceptable toxicity, or voluntary withdrawal. Subjects in complete response wishing to attempt stem cell collection following at least 6 months of induction treatment can hold lenalidomide for up to 30 days, and restart following stem cell collection.

Subjects will be monitored for Minimal Residual Disease (MRD) status in peripheral blood at baseline and completion of 12 cycles of induction treatment using Adaptive Biotechnology Clonoseq assay, and then every 4 cycles.

Subjects will be followed after completing study intervention every 6 months for alternate anti-cancer therapy and survival.

Being tested
Acalabrutinib, Lenalidomide, Rituximab, Obinutuzumab
Keywords
MRD, Minimal-residual-disease, Treatment naive, Untreated, Frontline, Acalabrutinib, Lenalidomide, Rituximab, Obinutuzumab
Medical subject headings
Lymphoma, Mantle-Cell, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcalabrutinibDrug

    Also called CALQUENCE, ACP-196

    Acalabrutinib, oral, 100 mg BID, continuous

  • LenalidomideDrug

    Also called Revlimid

    Lenalidomide, 15 mg for cycle 1, then escalated as tolerated to 20 mg, QD, Days 1-21 out of 28 day cycles

  • RituximabDrug

    Also called Rituxan

    Rituximab, IV, weekly during Cycle 1, and every other cycle starting with Cycle 4

  • ObinutuzumabDrug

    Also called Gazyva

    Obinutuzumab on days 1, 8, 15 of cycle 1, day 1 of cycles 2-6, then every 2 cycles

Study groups in NCT03863184
Study groupRoleWhat they receive
ALR in CombinationExperimentalAcalabrutinib, lenalidomide, and rituximab in combination
Receives: Drug: Acalabrutinib; Drug: Lenalidomide; Drug: Rituximab
ALO in CombinationExperimentalAcalabrutinib, lenalidomide and obinutuzumab in combination
Receives: Drug: Acalabrutinib; Drug: Lenalidomide; Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peripheral Blood Minimum Residual Disease (MRD)-Negative Complete Response (CR) Rate of the Combination of Acalabrutinib + Lenalidomide + Rituximab at the Conclusion of 12 Cycles of Induction Therapy

    Percentage of subjects with MRD-negative CR at the conclusion of 12 cycles of induction therapy. Each cycle is 28 days, 12 cycles is approximately 1 year.

    Measured: 1 year

Secondary outcomes (6)

  1. Safety of Combination Treatment With Acalabrutinib, Lenalidomide, and Rituximab as Measured by the Percentage of Subjects That Experience 1 or More Adverse Event

    Rate of subjects that experience 1 or more adverse events

    Measured: 4 years

  2. Overall Response Rate

    Rate of subjects who achieve a partial or complete response

    Measured: 4 years

  3. Complete Response Rate

    Rate of subjects who achieve a complete response

    Measured: 4 years

  4. Progression Free Survival

    Measured from start of treatment to time of progression or death from any cause, measured in months

    Measured: 4 years

  5. Overall Survival

    Measured from start of treatment to death from any cause, measured in months

    Measured: 4 years

  6. Time to Next Treatment

    Measured from end of study treatment to initiation of next lymphoma treatment, measured in months

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2019
  2. Study start11 Oct 2019
  3. Primary completion25 Apr 2024
  4. Study completion30 May 2028 (estimated)

Resources

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
Model description
Study intervention begins with an induction phase consisting of 12 cycles of acalabrutinib, lenalidomide, and rituximab (ALR). Responding subjects will be eligible to enter a maintenance phase. Subjects will continue maintenance ALR until disease progression, development of unacceptable toxicity, or voluntary withdrawal. Subjects in CR wishing to attempt stem cell collection following at least 6 months of induction treatment can hold lenalidomide for up to 30 days, and restart following stem cell collection.
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03863184
Sponsor's protocol ID
1807019439
Status last verified
Apr 2026
First submitted
1 Mar 2019
Last updated
28 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ruan J, Bond DA, Shah B, Allan JN, Rutherford SC, Gribbin C, Chen Z, Bhinder B, Tam W, Rossi D, Xiang J, Hobbie B, Harbhajan M, Sahni TK, Chen GZ, Sigouros M, Inghirami G, Chen-Kiang S, Elemento O, Maddocks K, Leonard JP, Martin P. MRD-driven initial therapy of acalabrutinib and lenalidomide plus rituximab or obinutuzumab for mantle cell lymphoma. Blood Adv. 2026 Feb 24;10(4):1381-1394. doi: 10.1182/bloodadvances.2025017760.

    PubMed 41289154

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acalabrutinib, Lenalidomide and Rituximab in people with Mantle Cell Lymphoma, run by Weill Medical College of Cornell University at 1 site 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 18 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 6 Jun 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?

Peripheral Blood Minimum Residual Disease (MRD)-Negative Complete Response (CR) Rate of the Combination of Acalabrutinib + Lenalidomide + Rituximab at the Conclusion of 12 Cycles of Induction Therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03863184, which also lists 1 linked publication.

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 28 Apr 2026.

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