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Mantle Cell LymphomaPhase 2NCT03282396

Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma

A Phase 2 study testing Ibrutinib in people with Mantle Cell Lymphoma, run by M.D. Anderson Cancer Center 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 phase II trial studies how well ibrutinib works in treating participants with untreated high risk smoldering mental cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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?
Ibrutinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
8 Jun 2020to 28 Feb 2028
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

  • Confirmed diagnosis of MCL with CD20 and cyclin D1 positivity or cyclin D1 negative MCL classic histology in tissue biopsy. Patients must have never received any prior therapy for their disease. Patients have been observed for 3 - 6 months with no progression as per imaging assessments
  • High risk smoldering MCL (i.e. patients without any B symptoms or any symptoms related to MCL warranting immediate systemic therapy) with at least one or more of these eligibility criteria:
  • Ki-67 of 15-30% (Ki-67% from involved tissue not bone marrow [BM], unless confirmed by pathologist),
  • White blood cells (WBC) 15-30k
  • Lymph node size 3-5 cm in diameter
  • Complex karyotype
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  • TP53 mutated or wild type and/or del17p (fluorescence in situ hybridization [FISH]% 10-50%)
  • MYC positive MCL. MYC positive (either by FISH or by immunohistochemistry [IHC] and confirmed by pathology at MD Anderson Cancer Center [MDACC])
  • Presence of either or KMT2D, BIRC3, NOTCH2, NSD2 or more than one mutation in the initial next generation sequencing (NGS) panel testing are allowed
  • Understand and voluntarily sign an institutional review board (IRB)-approved informed consent form
  • Age >= 18 years at the time of signing the informed consent
  • Patients should in general have bi-dimensional measurable disease with their biggest tumor less than or equal to 5 cm. (Bone marrow or gastrointestinal [GI] only involvement is acceptable)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Cardiology clearance is required. Discussion with cardiologist and co-principal investigator (PI) is required before starting ibrutinib
  • With minimal disease or absent disease related symptoms but anxious to start systemic therapy
  • Absence of cytopenia attributed to bone marrow (BM) infiltration
  • Absolute neutrophil count (ANC) > 1000/mm^3
  • Platelet count > 100,000/mm^3
  • Patients who have bone marrow infiltration by MCL are eligible if their ANC is >= than 500 or their platelet level is >= than 50,000 /mm^3. Platelet transfusions are allowed
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) < 3 x upper limit of normal or < 5 x upper limit of normal if hepatic metastases are present
  • Serum bilirubin < 1.5 mg/dl
  • Creatinine (Cr) clearance >= 30 mL/min
  • Disease free of prior malignancies for equal to or greater than 6 months with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated. Patients must be willing to receive transfusions of blood products
  • Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty and having a screening core biopsy
  • Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for >= 1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry
  • Male and female subjects who agree to use highly effective methods of birth control (e.g., implants, injectable, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug for females and 90 days for males

Who cannot join

  • Any serious medical condition including but not limited to uncontrolled hypertension, arrhythmias, diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, very painful, intolerable symptoms from splenomegaly, leukemic features, active hemorrhage, or psychiatric illness that, in the investigator's opinion, places the patient at unacceptable risk and would prevent the subject from signing the informed consent form
  • Patients with ANY of the following risk factors:
  • Clinically significant disease related symptoms (including significant B symptoms) compromising the performance status to more than 1
  • Blastoid variant histology
  • Pleomorphic variant histology
  • Ki-67 > 30%
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  • Bulky tumors > 5 cm
  • Central nervous system (CNS) involvement at diagnosis
  • All patients must not have received any prior treatment for mantle cell lymphoma
  • Prior exposure to BTK inhibitor
  • Pregnant or breastfeeding females
  • Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded
  • All patients with history of central nervous system lymphoma
  • History of stroke or intracranial hemorrhage within 6 months prior to signing the consent
  • Currently active, or past history/of clinically significant cardiovascular disease such as uncontrolled arrhythmia or any Class 3 or 4 congestive heart failure as defined by the New York Heart Association Classification, or even controlled arrhythmias (any grade) on medications or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
  • Patients with prior history of atrial fibrillation or any type of cardiac arrhythmias and/or who underwent ablation and are in normal sinus rhythm (exceptions include patients who are asymptomatic and those who are given cardiology clearance)
  • Unable to swallow capsules, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  • Requires concomitant anticoagulation with warfarin or equivalent vitamin K antagonist, active treatment for pulmonary embolism (PE)/ deep vein thrombosis (DVT) and persons with mechanical cardiac valves
  • Subject who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of ibrutinib or subject who requires continuous treatment with a strong CYP3A inhibitor
  • Subjects with chronic liver disease and hepatic impairment meeting Child-Pugh class C
  • Any uncontrolled active systemic infection
  • Major surgery within 4 weeks of first dose of study drug
  • Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
  • Recent infection requiring systemic treatment that was completed =< 14 days before the first dose of study drug
  • Known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version [v] 4.0), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
  • Concurrent systemic immunosuppressant therapy within 21 days of the first dose of study drug

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Trial of Ibrutinib in Perviously Untreated High Risk Smoldering Mantle Cell Lymphoma (MCL)

This phase II trial studies how well ibrutinib works in treating participants with untreated high risk smoldering mental cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To measure the progression-free survival (PFS) in previously untreated high-risk smoldering mental cell lymphoma (MCL) patients treated with ibrutinib.

SECONDARY OBJECTIVES:

  1. To evaluate the safety of ibrutinib in previously untreated high risk smoldering MCL.

II. To evaluate the response rate and duration of response of ibrutinib. III. To study clonal evolution in MCL while under ibrutinib.

EXPLORATORY OBJECTIVES:

  1. To collect serial samples for our correlative study (plasma, peripheral blood mononuclear cells [PBMC], initial tumor biopsy).

OUTLINE:

Participants receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for 5 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up every 2 months for 6 months, every 2-4 months for 2 years, then every 4-6 months thereafter.

Being tested
Ibrutinib
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.

  • IbrutinibDrug

    Also called BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765

    Given PO

Study groups in NCT03282396
Study groupRoleWhat they receive
Treatment (ibrutinib)ExperimentalParticipants receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days for 5 years in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Ibrutinib

What is being measured

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

  1. Progression free survival

    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.

    Measured: Up to 3.5 years

Secondary outcomes (4)

  1. Incidence of adverse events

    Logistic regression will be utilized to assess the effect of patient prognostic factors on the toxicity rate. Toxicity data by type and severity will be summarized by frequency tables.

    Measured: Up to 3.5 years

  2. Response rate of ibrutinib

    Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate.

    Measured: Up to 3.5 years

  3. Response duration

    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.

    Measured: Up to 3.5 years

  4. Overall survival

    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.

    Measured: Up to 3.5 years

Timeline

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

  1. First posted13 Sep 2017
  2. Study start8 Jun 2020
  3. Primary completion28 Feb 2028 (estimated)
  4. Study completion28 Feb 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03282396
Sponsor's protocol ID
2016-0914
Other IDs
NCI-2018-01045, 2016-0914
Status last verified
Jul 2026
First submitted
12 Sep 2017
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibrutinib in people with Mantle Cell Lymphoma, run by M.D. Anderson Cancer Center 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 26 inclusion and 27 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 16 Jul 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?

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?

Progression free survival (time frame: Up to 3.5 years). 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 NCT03282396.

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 16 Jul 2026.

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