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LymphomaPhase 2NCT01779791

A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma

A Phase 2 study testing PCI-32765 (Ibrutinib) in people with Lymphoma, run by Janssen Research & Development, LLC at 54 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 PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
PCI-32765 (Ibrutinib)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
54 sitesin 9 countries
Study dates
17 Apr 2013to 18 May 2016
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

  • Histologic proof of Grade 1, 2, or 3a follicular lymphoma (FL) without clinical or pathological evidence of transformation
  • Previously treated with at least 2 prior lines of therapy, including at least 1 rituximab combination chemotherapy regimen; last prior line of therapy includes an anti CD20 monoclonal antibody-containing chemotherapy regimen (separate lines of therapy are defined as different regimens that are either separated by disease progression, refractory disease, or relapsed disease)
  • Resistant disease to the last therapy, defined as progression of disease during or within 12 months of the last dose of chemotherapy in a CD20 antibody combination chemotherapy regimen
  • At least 1 measurable site of disease according to International Working Group Revised Response Criteria for Malignant Lymphoma
  • Eastern Cooperative Oncology Group performance status grade 0 or 1
  • Hematology and biochemical laboratory values must be within protocol-defined parameters within 7 days prior to enrollment
  • Agrees to protocol-defined use of effective contraception
  • Women of childbearing potential must have a negative serum or urine pregnancy test at screening

Who cannot join

  • Prior nitrosoureas within 6 weeks, chemotherapy within 3 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 first dose of study drug
  • Prior treatment with PCI-32765 or other Bruton's tyrosine kinase inhibitors (patients who progressed or became refractory while on treatment with PI3K inhibitors are excluded)
  • Concurrent enrollment in another therapeutic investigational clinical treatment study
  • Received a prior allogeneic hematopoietic stem cell transplant (prior autologous hematopoietic stem cell transplant is allowed)
  • Known central nervous system lymphoma
  • History of prior malignancy (except malignancy treated with curative intent and with no known active disease present for >=3 years before enrollment, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, or adequately treated cervical carcinoma in situ without evidence of disease)
Show all 13Show fewer
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists
  • Requires treatment with strong cytochrome P450 (CYP)3A4/5 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 (HIV) or active infection with Hepatitis C or active infection with Hepatitis B or any uncontrolled active systemic infection requiring intravenous antibiotics
  • Women who are pregnant or breastfeeding
  • 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 PCI-32765 capsules, or put the study outcomes at undue risk

Trial locations and contacts

54 sites in 9 countries.

54 sites in 9 countries

United States20 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Baltimore, Maryland

  • Study site

    Burlington, Vermont

  • Study site

    Chicago, Illinois

  • Study site

    Detroit, Michigan

  • Study site

    Greenville, North Carolina

  • Study site

    Hackensack, New Jersey

  • Study site

    Houston, Texas

  • Study site

    Lexington, Kentucky

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    New Brunswick, New Jersey

  • Study site

    New York, New York

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Seattle, Washington

  • Study site

    Stanford, California

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Westwood, Kansas

Other trials in United States

France7 sites

  • Study site

    Créteil

  • Study site

    Nice

  • Study site

    Nîmes

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Pierre-Bénite

  • Study site

    Rennes

Other trials in France

Australia5 sites

  • Study site

    Adelaide

  • Study site

    Concord

  • Study site

    Melbourne

  • Study site

    Milton

  • Study site

    Prahran

Other trials in Australia

Russia5 sites

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Saint Petersburg

  • Study site

    Volgograd

  • Study site

    Yekaterinburg

Other trials in Russia

Germany4 sites

  • Study site

    Cologne

  • Study site

    Heidelberg

  • Study site

    Mainz

  • Study site

    Ulm

Other trials in Germany

United Kingdom4 sites

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Southampton

Other trials in United Kingdom

Belgium3 sites

  • Study site

    Courrière

  • Study site

    Ghent

  • Study site

    Leuven

Other trials in Belgium

Poland3 sites

  • Study site

    Krakow

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Spain3 sites

  • Study site

    Barcelona

  • Study site

    Marbella

  • Study site

    Salamanca

Other trials in Spain

About this study

Official title: An Open-Label, Multicenter, Single-Arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects With Refractory Follicular Lymphoma

The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).

Read the detailed description

This is an open-label (identity of assigned study drug will be known) study of PCI-32765 (ibrutinib) in approximately 110 patients with chemoimmunotherapy-resistant FL whose disease has relapsed from at least 2 prior lines of therapy, including at least 1 rituximab combination chemotherapy regimen. Each patient must have resistant disease to the last therapy (defined as progression of disease [PD] during or within 12 months of the last dose of chemotherapy in a CD20 antibody combination chemotherapy regimen). The study will include the following phases: screening (up to 30 days prior to the first dose of study drug), treatment (until PD or unacceptable toxicity), and posttreatment follow-up (until death, lost to follow up, withdrawal of consent, or study end [defined as 2 years after the last patient is enrolled]). Patients will receive 560 mg of PCI-32765 by mouth once daily on a 21-day cycle. Treatment will be continuous (without interruption) and self-administered at home. The treatment phase will extend from administration of the first dose of study medication until PD or unacceptable toxicity. If a patient who had radiological evidence of PD is clinically stable or improving or exhibiting signs of tumor flare without confirmation of PD by PET or biopsy, they may continue treatment with ibrutinib upon request by the investigator and approval by the sponsor. Posttreatment follow-up will extend from the end of treatment until death, lost to follow up, withdrawal of consent, or study end. Every patient, except for those who explicitly withdraw consent from further site contact, will be followed for survival status until the study ends. In addition, data on subsequent antineoplastic therapy will also be collected. Serial pharmacokinetic samples will be collected and efficacy and safety will be monitored throughout the study. A separate assessment of pharmacokinetics is planned for patients who receive a strong or moderate CYP3A4/5 inhibitor while receiving treatment with ibrutinib. For patients who have already discontinued ibrutinib due to PD, have taken no other anticancer therapy, and now have a radiologically documented delayed response, resumption of ibrutinib is permitted on a case-by-case basis, upon request by the investigator and approval of the sponsor.

Conditions
Lymphoma
Being tested
PCI-32765 (Ibrutinib)
Keywords
Lymphoma, Refractory follicular lymphoma, Chemoimmunotherapy-resistant follicular lymphoma, PCI-32765, Ibrutinib, IMBRUVICA
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

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

  • PCI-32765 (Ibrutinib)Drug

    Also called IMBRUVICA

    560 mg capsules administered orally once daily, continuously on a 21-day cycle until progressive disease.

Study groups in NCT01779791
Study groupRoleWhat they receive
PCI-32765 (Ibrutinib)ExperimentalNot described
Receives: Drug: PCI-32765 (Ibrutinib)

What is being measured

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

  1. Overall response rate

    Measured: Up to 2 years after the last patient is enrolled

Secondary outcomes (11)

  1. Duration of response

    Measured: Every 12 weeks during the first 96 weeks, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled)

  2. Progression-free survival

    Measured: Up to progressive disease, death, lost to follow-up, withdrawal of consent, or study end (up to 2 years after the last patient is enrolled)

  3. Overall survival

    Measured: Up to death, lost to follow-up, withdrawal of consent, or study end (up to 2 years after the last patient is enrolled)

  4. Time to response

    Measured: Every 12 weeks during the first 96 weeks, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled)

  5. Number of patients experiencing resolution of lymphoma-related B symptoms

    Measured: Day 1 of every cycle during the first 12 months, thereafter every other cycle (up to 2 years after the last patient is enrolled)

  6. Number of patients identified with blood biomarkers that alter B-cell receptor signaling or activate alternative signaling pathways

    Measured: Day 1 of Cycles 1-3, and time of disease progression, or at end-of treatment visit for patients who discontinue treatment without disease progression

  7. Minimum plasma concentration of PCI-32765

    Measured: Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours

  8. Oral plasma clearance of PCI-32765

    Measured: Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours

  9. Oral volume of distribution at steady state of PCI-32765

    Measured: Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours

  10. Area under the plasma-concentration time curve of PCI-32765

    Measured: Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours

  11. Number of participants affected by an adverse event

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

Timeline

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

  1. First posted30 Jan 2013 (estimated)
  2. Study start17 Apr 2013
  3. Primary completion18 May 2016
  4. Study completion18 May 2016

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
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01779791
Sponsor's protocol ID
CR100956
Other IDs
2012-004097-26, PCI-32765FLR2002
Status last verified
Jul 2017
First submitted
25 Jan 2013
Last updated
18 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Balasubramanian S, Hodkinson B, Schuster SJ, Fowler NH, Trotman J, Hess G, Cheson BD, Schaffer M, Sun S, Deshpande S, Vermeulen J, Salles G, Gopal AK. Identification of a genetic signature enriching for response to ibrutinib in relapsed/refractory follicular lymphoma in the DAWN phase 2 trial. Cancer Med. 2022 Jan;11(1):61-73. doi: 10.1002/cam4.4422. Epub 2021 Nov 17.

    PubMed 34791836

  • Gopal AK, Schuster SJ, Fowler NH, Trotman J, Hess G, Hou JZ, Yacoub A, Lill M, Martin P, Vitolo U, Spencer A, Radford J, Jurczak W, Morton J, Caballero D, Deshpande S, Gartenberg GJ, Wang SS, Damle RN, Schaffer M, Balasubramanian S, Vermeulen J, Cheson BD, Salles G. Ibrutinib as Treatment for Patients With Relapsed/Refractory Follicular Lymphoma: Results From the Open-Label, Multicenter, Phase II DAWN Study. J Clin Oncol. 2018 Aug 10;36(23):2405-2412. doi: 10.1200/JCO.2017.76.8853. Epub 2018 May 31.

    PubMed 29851546

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PCI-32765 (Ibrutinib) in people with Lymphoma, run by Janssen Research & Development, LLC at 54 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 8 inclusion and 13 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 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, France, Australia, Russia, Germany 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: Up to 2 years 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 NCT01779791, which also lists 2 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 18 Jul 2017.

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