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Contiguous Stage II Mantle Cell LymphomaPhase 2NCT02242097

Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma

A Phase 2 study testing ibrutinib and laboratory biomarker analysis in people with Contiguous Stage II Mantle Cell Lymphoma and Noncontiguous Stage II Mantle Cell Lymphoma, run by Northwestern University at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is being done to see whether or not a drug called ibrutinib can be given to patients with mantle cell lymphoma (MCL) as maintenance therapy after induction chemotherapy. This drug blocks an enzyme that affects how the lymphocytes grow and survive. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ibrutinib and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
5 sitesUnited States
Study dates
12 Jan 2015to 5 Jan 2023
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 have histologically confirmed mantle cell lymphoma (MCL)
  • Please note: Measurable disease is not required, but will be followed if it exists
  • Patients must have received 4 or more cycles of one of the following prior systemic induction chemotherapy regimens:
  • Rituximab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunomycin), vincristine sulfate (Oncovin), prednisone (R-CHOP) (with or without alternating rituximab, dexamethasone, cytarabine [ara-c], cisplatin [platinum] [R-DHAP]) with or without autologous (auto) stem cell transplant (SCT)
  • Hyper-cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride (adriamycin), dexamethasone (CVAD) with or without auto SCT
  • Bendamustine + rituximab with or without auto SCT
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  • Please note:
  • Patients who received combinations of the above regimens are not eligible for enrollment
  • At the time of registration, patients must be at least 14 days out from last dose of cytotoxic chemotherapy, but no more than 90 days; if a patient underwent auto SCT, he/she must demonstrate engraftment (per treating investigator's discretion) and must meet all other hematological requirements as outlined below
  • Patients must have achieved a response to induction chemotherapy (either CR or PR by Cheson 2007 criteria) and be without known progression
  • Patients may have received prior radiotherapy
  • Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Absolute neutrophil count (ANC) >= 1000/mm^3, independent of growth factor support
  • Platelets >= 100,000/mm^3, or >= 50,000 in cases of ongoing bone marrow involvement (in either case, these must be independent of transfusion support)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SPGT]) =< 3 x ULN
  • Creatinine clearance >= 25 ml/min
  • Please note: Patients who do not meet the above criteria because of Gilbert's Syndrome are still eligible
  • Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation (see timelines below for women and men); in addition, men must agree not to donate sperm during and after study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • NOTE: For female patients, these restrictions apply for 1 month after the last dose of study drug; for male patients, these restrictions apply for 3 months after the last dose of study drug
  • NOTE: A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Female patients must have a negative pregnancy test (blood or urine) within 28 days prior to registration
  • Patients must be willing and able to avoid consuming food and beverages containing grapefruit or Seville oranges while on ibrutinib study therapy
  • Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Who cannot join

  • Patients who have received >= 7 days of prior ibrutinib or any prior treatment with another Bruton tyrosine kinase (BTK) inhibitor are not eligible
  • Patients receiving ongoing treatment with any other investigational agents are not eligible
  • Patients receiving live/attenuated vaccinations within 4 weeks prior to registration are not eligible
  • Patients with a known central nervous system (CNS) involvement of lymphoma are not eligible (CNS staging not required)
  • Patients who have undergone major surgery within 4 weeks prior to registration are not eligible
  • Patients diagnosed or treated for malignancy other than MCL are not eligible unless they meet one of the following exceptions:
Show all 27Show fewer
  • Malignancy treated with curative intent and with no known active disease present for >= 3 years before registration and felt to be at low risk for recurrence by the treating physician
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated cervical carcinoma in situ without evidence of disease
  • Patients with a history of stroke or intracranial hemorrhage within 6 months prior to registration are not eligible
  • Patients who require anticoagulation with warfarin or equivalent vitamin K antagonists are not eligible
  • Patients who require chronic treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) inhibitors are not eligible
  • NOTE: Patients who are currently on treatment with strong CYP3A4/5 inhibitors may be eligible if they are able to be switched to an alternative therapy that is not a strong CYP3A4/5 inhibitor prior to registration on study
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib are not eligible
  • Patients with uncontrolled intercurrent illness including, but not limited to, any of the following are not eligible:
  • Ongoing or active systemic infection
  • Symptomatic congestive heart failure
  • Myocardial infarction within 6 months prior to registration
  • Unstable angina pectoris
  • Uncontrolled or symptomatic cardiac arrhythmias
  • Any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Patients who have any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at risk are not eligible
  • Patients with a known human immunodeficiency virus (HIV) infection are not eligible (HIV testing not required)
  • Patients with a known John Cunningham (JC) virus infection and/or progressive multifocal leukoencephalopathy (PML) are not eligible
  • Patients with clinically active hepatitis A, B, or C infections are not eligible
  • Female patients who are pregnant and/or lactating are not eligible

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Northwestern University- Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • University of Utah

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: A Phase II Clinical Trial Evaluating Ibrutinib Maintenance Following Intensive Induction for Patients With Previously Untreated Mantle Cell Lymphoma (MCL)

This study is being done to see whether or not a drug called ibrutinib can be given to patients with mantle cell lymphoma (MCL) as maintenance therapy after induction chemotherapy. This drug blocks an enzyme that affects how the lymphocytes grow and survive. The investigators hope to learn how safe and effective ibrutinib is for treating patients with MCL after responding to induction chemotherapy.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the progression-free survival (PFS) rate after 3 years.

SECONDARY OBJECTIVES:

  1. Assess toxicity. II. Determine rates of conversion from partial response (PR) to complete response (CR).

III. Determine median overall survival (OS) after 4 years.

TERTIARY OBJECTIVES:

  1. Compare minimal residual disease (MRD) results overtime by polymerase chain reaction (PCR) and correlate these with PFS and OS.

OUTLINE:

Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity or patient preference.

After completion of study treatment, patients who completed 4 years of treatment are followed up at 30 days. Patients who did not complete 4 years of treatment are followed up for up to 4 years post-first dose of treatment (every 3 months for 2 years and then every 6 months for 4 years).

Being tested
ibrutinib, laboratory biomarker analysis
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 Bruton's tyrosine kinase inhibitor PCI-32765, BTK inhibitor PCI-32765, CRA-032765, Imbruvica

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT02242097
Study groupRoleWhat they receive
Treatment (ibrutinib)ExperimentalPatients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.
Receives: Drug: ibrutinib; Other: laboratory biomarker analysis

What is being measured

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

  1. Determine the Progression-free Survival (PFS) Rate After 3 Years

    PFS will be measured from start of treatment to time of progression. Evidence of clinical progression will be documented by imaging (CT scan) for patients who have measurable disease. Progression is defined using the LUGANO Criteria, as a Deauville score of 4 or 5 (increased uptake compared to baseline) or the appearance of new lesions

    Measured: Assessed at 3 years

Secondary outcomes (3)

  1. Incidence of Adverse Events, Defined According to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.0

    To assess toxicity, all adverse events will be summarized as to type, severity, frequency, timing and attribution. Treatment related Adverse Events Occurring with Incidence of greater that or equal to 20% of patients treated with Ibrutinib Maintenance are shown here.

    Measured: Up to 30 days after completion of study treatment, maximum 4 years post-first dose

  2. Rate of Conversion From Partial Response (PR) to Complete Response (CR)

    Progression will be evaluated using Cheson 2007 criteria, only patients who had a PR at the time of registration and who complete ≥ 1 complete cycle of ibrutinib maintenance therapy will be evaluable for this endpoint.

    Measured: Up to 4 years

  3. Overall Survival (OS) After 4 Years

    Patients will be evaluated monthly for the first 6 months on treatment, then every 3 months thereafter. Patients who go off treatment will continue to be followed for up to 4 years post-first dose. Follow-up will occur every 3 months (up to 2 years after the first dose of treatment) and then every 6 months thereafter (up to 4 years post-first dose). OS after 4 years will be calculated as a percentage of patient alive.

    Measured: Up to 4 years post-first dose

Timeline

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

  1. First posted16 Sep 2014 (estimated)
  2. Study start12 Jan 2015
  3. Primary completion7 Dec 2021
  4. Study completion5 Jan 2023

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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02242097
Sponsor's protocol ID
NU 14H06
Other IDs
NCI-2014-01777, PCI-32765MCL2003, STU00098385, NU 14H06, P30CA060553
Status last verified
May 2026
First submitted
12 Sep 2014
Last updated
10 Jun 2026
Data monitoring committee
Yes

Publications

  • Karmali R, Abramson JS, Stephens DM, Barnes J, Winter JN, Ma S, Gao J, Kaplan J, Petrich AM, Hochberg E, Takvorian T, Mi X, Nelson V, Gordon LI, Pro B. Ibrutinib maintenance after frontline treatment in patients with mantle cell lymphoma. Blood Adv. 2023 Dec 12;7(23):7361-7368. doi: 10.1182/bloodadvances.2023011271.

    PubMed 37756532

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ibrutinib and laboratory biomarker analysis in people with Contiguous Stage II Mantle Cell Lymphoma and Noncontiguous Stage II Mantle Cell Lymphoma, run by Northwestern University at 5 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 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: finished, as of the sponsor's last update on 10 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 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 12 Mar 2024). 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?

Determine the Progression-free Survival (PFS) Rate After 3 Years (time frame: Assessed at 3 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 NCT02242097, 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 10 Jun 2026.

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