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Mantle Cell LymphomaPhase 2NCT01599949

A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

A Phase 2 study testing Ibrutinib in people with Mantle Cell Lymphoma, run by Janssen Research & Development, LLC at 56 sites in 9 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
56 sitesin 9 countries
Study dates
Aug 2012to May 2015
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Diagnosis of confirmed mantle cell lymphoma (MCL) with at least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
  • Must have received at least 1 prior rituximab-containing chemotherapy regimen, but no more than 5 prior regimens
  • Must have received at least 2 cycles of bortezomib therapy (single-agent or in combination) and have documented progressive disease during or after bortezomib therapy
  • Eastern Cooperative Oncology Group performance status score 0, 1, or 2
  • Hematology and biochemical values within protocol-defined parameters

Who cannot join

  • Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of the first dose of study drug
  • Prior treatment with ibrutinib or other Bruton's tyrosine kinase inhibitors
  • More than 5 prior lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a >6 month treatment-free interval
  • Known central nervous system lymphoma
  • Diagnosed or treated for malignancy other than MCL, except malignancy treated with curative intent and with no known active disease present for >=3 years before the first dose of study drug 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, or adequately treated cervical carcinoma in situ without evidence of disease.
  • History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug
Show all 11Show fewer
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists
  • Requires treatment with strong CYP3A4/5 inhibitors
  • 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 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
  • Known history of human immunodeficiency virus or active infection with hepatitis C virus or hepatitis B virus or any uncontrolled active systemic infection
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk

Trial locations and contacts

56 sites in 9 countries.

56 sites in 9 countries

United States32 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Baltimore, Maryland

  • Study site

    Boston, Massachusetts

  • Study site

    Burlington, Vermont

  • Study site

    Charlottesville, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Detroit, Michigan

  • Study site

    Goshen, Indiana

  • Study site

    Hackensack, New Jersey

  • Study site

    Houston, Texas

  • Study site

    Iowa City, Iowa

  • Study site

    Jacksonville, Florida

  • Study site

    Jefferson City, Missouri

  • Study site

    La Jolla, California

  • Study site

    Lexington, Kentucky

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Madison, Wisconsin

  • Study site

    Metairie, Louisiana

  • Study site

    Morgantown, West Virginia

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Norwalk, Connecticut

  • Study site

    Omaha, Nebraska

  • Study site

    Peoria, Illinois

  • Study site

    Sioux City, Iowa

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    Syracuse, New York

  • Study site

    Watertown, South Dakota

  • Study site

    Westwood, Kansas

  • Study site

    Worcester, Massachusetts

Other trials in United States

Israel7 sites

  • Study site

    Afula

  • Study site

    Beer Yaakov

  • Study site

    Hadera

  • Study site

    Haifa

  • Study site

    Nahariya

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

Other trials in Israel

France5 sites

  • Study site

    Grenoble

  • Study site

    Mulhouse

  • Study site

    Nantes

  • Study site

    Pessac

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

Russia3 sites

  • Study site

    Nizhny Novgorod

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

Other trials in Russia

Belgium2 sites

  • Study site

    Bruges

  • Study site

    Ghent

Other trials in Belgium

Poland2 sites

  • Study site

    Chorzów

  • Study site

    Lodz

Other trials in Poland

Spain2 sites

  • Study site

    Barcelona

  • Study site

    Salamanca

Other trials in Spain

United Kingdom2 sites

  • Study site

    London

  • Study site

    Plymouth

Other trials in United Kingdom

Puerto Rico1 site

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy.

Read the detailed description

This is a single-arm (all patients will receive the study drug) study to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma (MCL) who have received at least 1 rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy. Approximately 110 eligible patients will be enrolled. During the treatment phase, patients will receive 560 mg of ibrutinib by mouth once daily continuously until disease progression, unacceptable toxicity, or study end, whichever occurs first. Treatment will be continuous (without interruption) and self-administered at home. Doses can be held or reduced based on the severity of and the recovery from side effects of the study drug. The sponsor will ensure that patients benefiting from treatment with ibrutinib will be able to continue treatment after the end of the study. Data will be collected on disease response to the treatment, on progression-free survival, overall survival, and subsequent anti-MCL therapies. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected as detailed in the protocol. Safety will be monitored throughout the study. An interim analysis of the pharmacokinetic data will occur approximately 3 months after the scheduled pharmacokinetic sampling in Cycles 1 and 2 has been completed. Data will be analyzed 1 year after the last patient is enrolled for the primary analysis and 2 years after last patient is enrolled for the final follow-up.

Being tested
Ibrutinib
Keywords
Mantle cell lymphoma, Ibrutinib, Bruton's tyrosine kinase inhibitor, Rituximab, Bortezomib
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

    Type=exact number, unit=mg, number=560, form=capsule, route=oral use. 560 mg oral ibrutinib is to be administered once daily continuously until disease progression, unacceptable toxicity, or study end, whichever occurs first. Doses can be held or reduced based on the severity of and the recovery from side effects of the study drug.

Study groups in NCT01599949
Study groupRoleWhat they receive
IbrutinibExperimentalNot described
Receives: Drug: Ibrutinib

What is being measured

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

  1. Overall response rate

    Measured: 1 year after the last patient is enrolled

Secondary outcomes (10)

  1. Overall survival rate

    Measured: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled

  2. Progression-free survival rate

    Measured: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled

  3. Mean change from baseline in the Lym subscale

    Measured: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled

  4. Mean change from baseline in the EQ-5D-5L index

    Measured: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled

  5. Mean plasma concentrations of ibrutinib

    Measured: Up to Cycle 2, Day 21

  6. Maximum observed plasma concentration of ibrutinib

    Measured: Up to Cycle 2, Day 21

  7. Minimum observed plasma concentration of ibrutinib

    Measured: Up to Cycle 2, Day 21

  8. Area under the plasma concentration-time curve from time 0 to 24 hours of ibrutinib

    Measured: Up to Cycle 2, Day 21

  9. The number of participants affected by an adverse event

    Measured: Up to 30 days after the last dose of study medication

  10. Overall response rate

    Measured: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled

Timeline

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

  1. First posted16 May 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

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
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01599949
Sponsor's protocol ID
CR100847
Other IDs
PCI-32765MCL2001, 2012-000711-88
Status last verified
May 2016
First submitted
14 May 2012
Last updated
1 Jun 2016
Results posted
No
Data monitoring committee
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 Janssen Research & Development, LLC at 56 sites in 9 countries.

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 5 inclusion and 11 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 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Israel, France, Russia, Belgium and 4 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall response rate (time frame: 1 year after the last patient is enrolled). 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 NCT01599949.

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 1 Jun 2016.

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