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Mantle Cell LymphomaPhase 2PCYC-1104-CANCT01236391

Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL)

A Phase 2 study testing PCI-32765 in people with Mantle Cell Lymphoma, run by Pharmacyclics LLC. at 18 sites in 4 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 primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population. 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?
PCI-32765
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
18 sitesin 4 countries
Study dates
Feb 2011to Jan 2014
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

  • Men and women ≥ 18 years of age
  • ECOG performance status of ≤ 2
  • Pathologically confirmed MCL, with documentation of either overexpression of cyclin D1 or t(11;14), and measurable disease on cross sectional imaging that is ≥ 2 cm in the longest diameter and measurable in 2 perpendicular dimensions
  • Documented failure to achieve at least partial response (PR) with, or documented disease progression disease after, the most recent treatment regimen
  • At least 1, but no more than 5, prior treatment regimens for MCL (Note: Subjects having received ≥2 cycles of prior treatment with bortezomib, either as a single agent or as part of a combination therapy regimen, will be considered to be bortezomib-exposed.)
  • Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
Show all 17Show fewer
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)
  • Major exclusion criteria:
  • Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 2 weeks of first dose of study drug
  • 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 PCI-32765 capsules, or put the study outcomes at undue risk
  • 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
  • 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
  • Any of the following laboratory abnormalities:
  • Absolute neutrophil count (ANC) < 750 cells/mm3 (0.75 x 109/L) unless there is documented bone marrow involvement
  • Platelet count < 50,000 cells/mm3 (50 x 109/L) independent of transfusion support unless there is documented bone marrow involvement
  • Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN)
  • Creatinine > 2.0 x ULN

Who cannot join

None listed.

Trial locations and contacts

18 sites in 4 countries.

18 sites in 4 countries

United States9 sites

  • University of Virginia School of Medicine Hospital

    Charlottesville, Virginia, 22908

  • The Ohio Sate university

    Columbus, Ohio, 43210

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Cll Research and Treatment Program

    New Hyde Park, New York, 11042

  • New York Presbyterian Hospital/Cornell Medical Center

    New York, New York, 94305

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

United Kingdom4 sites

  • Centre for Experimental Cancer Medicine

    London, EC1M6BQ

  • Christie Hospital

    Manchester, M20 4BX

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Poland3 sites

  • Oddzail Kliniczny Onkologil

    Bydgoszcz, 85-796

  • Malopolskie Centrum Medyczne

    Krakow, 30-510

  • MTZ Clinical Research Sp. z o.o.

    Warsaw, 02-106

Other trials in Poland

Germany2 sites

  • Klinikum der Universitat Munchen - Campus Grosshadern

    München, D - 81377

  • Universitatsklinikum Ulm, Klinik fur Innere Medizin II

    Ulm, 89081

Other trials in Germany

About this study

Official title: Multicenter Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Relapsed or Refractory Mantle Cell Lymphoma

The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL.

The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population.

Read the detailed description

This is a Phase 2, open-label, nonrandomized, multicenter, monotherapy study in subjects with histologically documented MCL who have relapsed after ≥ 1 (but not > 5) prior treatment regimens. All subjects meeting eligibility criteria will receive PCI-32765 capsules at a dosage of 560 mg/day once daily for a 28-day cycle until disease progression, unacceptable toxicity, or enrollment in a long-term extension study, whichever occurs earlier.

Being tested
PCI-32765
Keywords
Pharmacyclics, Mantle, Mantle Cell, Lymphoma, Non-Hodgkins, Bortezomib, Velcade, Naive, PCYC
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma

What participants receive

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

  • PCI-32765Drug

    560 mg daily

Study groups in NCT01236391
Study groupRoleWhat they receive
Participants received PCI-32765 560 mg dailyExperimentalParticipants were enrolled and received 560 mg/day dose, stratified into 2 groups based on prior bortezomib exposure.
Receives: Drug: PCI-32765

What is being measured

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

  1. Percentage of Participants Achieving Response

    The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin's lymphoma (Cheson et al, 2007), as assessed by the investigator. CR is a complete disappearance of all disease, no new lesions, lymph nodes must have regressed and be PET negative, spleen and liver should not be palpable and without nodules, and bone marrow must be negative. PR is a >/= 50% decrease in the sum of the product of diameters of the target lesions, and >/= 50% decrease of splenic and hepatic nodules from baseline, no new lesions and no increase in the size of liver, spleen or non-target lesions.

    Measured: The median follow-up time on study for all treated participants is 15.3 (range 1.9 - 22.3) months

Secondary outcomes (3)

  1. Number of Participants With Treatment Emergent Adverse Events (AEs)

    Number of participants who had experienced at least one treatment emergent AE

    Measured: From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure

  2. PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765

    Area under the plasma concentration-time curve using data collected at 0, 1, 2, 4, 6-8, and 24 hours post dose (AUC0-24h)

    Measured: Performed During the First Month of Receiving PCI-32765

  3. Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score

    Mean change from baseline to Cycle 5 in the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) Global Health Status Score according to EORTC QLQ-C30 Scoring Manual (3rd Edition, 2001). For global health status, positive changes indicated better health status or functioning, and negative changes indicated worsening of health status or functioning. Scale scores range from 0 to 100. A change in 5 to 10 points in either direction represents a small change; 10 to 20 points represents a moderate change and greater than 20 points represents a large change.

    Measured: From Baseline to Cycle 5 (Week 20)

Timeline

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

  1. First posted8 Nov 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionJan 2014
  4. Study completionJan 2014

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
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01236391
Sponsor's protocol ID
PCYC-1104-CA
Other IDs
PCI-32765
Acronym
PCYC-1104-CA
Status last verified
Aug 2015
First submitted
18 Oct 2010
Last updated
28 Aug 2015
Data monitoring committee
No

Publications

  • Wang ML, Blum KA, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Zhang L, Baher L, Cheng M, Lee D, Beaupre DM, Rule S. Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results. Blood. 2015 Aug 6;126(6):739-45. doi: 10.1182/blood-2015-03-635326. Epub 2015 Jun 9.

    PubMed 26059948

  • Marostica E, Sukbuntherng J, Loury D, de Jong J, de Trixhe XW, Vermeulen A, De Nicolao G, O'Brien S, Byrd JC, Advani R, McGreivy J, Poggesi I. Population pharmacokinetic model of ibrutinib, a Bruton tyrosine kinase inhibitor, in patients with B cell malignancies. Cancer Chemother Pharmacol. 2015 Jan;75(1):111-21. doi: 10.1007/s00280-014-2617-3. Epub 2014 Nov 8.

    PubMed 25381051

  • Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Li L, Zhang L, Newberry K, Ou Z, Cheng N, Fang B, McGreivy J, Clow F, Buggy JJ, Chang BY, Beaupre DM, Kunkel LA, Blum KA. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013 Aug 8;369(6):507-16. doi: 10.1056/NEJMoa1306220. Epub 2013 Jun 19.

    PubMed 23782157

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PCI-32765 in people with Mantle Cell Lymphoma, run by Pharmacyclics LLC. at 18 sites in 4 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 17 inclusion and 0 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 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, United Kingdom, Poland, Germany. 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 13 Mar 2015). 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?

Percentage of Participants Achieving Response (time frame: The median follow-up time on study for all treated participants is 15.3 (range 1.9 - 22.3) months). 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 NCT01236391, which also lists 3 linked publications.

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 Aug 2015.

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