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Primary Central Nervous LymphomaPhase 2iLOCNCT02542514

Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma

A Phase 2 study testing Ibrutinib in people with Primary Central Nervous Lymphoma and Intraocular Lymphoma, run by The Lymphoma Academic Research Organisation at 10 sites in France.

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 study is an open label, prospective, multicenter, phase II study which aims to define ibrutinib efficacy in patients with relapsed or refractory primary central nervous lymphoma (PCNSL) or intraocular lymphoma (IOL) as measured by the disease control (DC) rate (complete response (CR) + uncertain complete response… Read more about this study

Who is it for?
Ages 18 years and older
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
52 participants
Where
10 sitesFrance
Study dates
Sep 2015to 1 Dec 2021
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

  • Histologically confirmed diagnosis of PCNSL or cytologically proven diagnosis of IOL or lymphomatous meningitis of B-cell type. In case of CNS lymphoma relapse or refractory PCNSL, cerebral biopsies are not required if imaging reveals typical images of PCNSL. In case of isolated IOL relapse, vitrectomy is not required if i) vitrectomy was part of the initial diagnosis workout, and ii) ocular examination and dosage of IL-10 in the anterior chamber of the eye performed at relapse or progression are highly in favour of IOL relapse (> 50 pg/ml in aqueous humor or 400 pg/ml in vitreous).
  • Aged 18 years and older.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
  • Life expectancy ≥ 3 months.
  • No more than 4 lines of anti-cancer treatment received.
  • Patients must have recovered within 28 days to a grade ≤ 1 from all toxicities related to prior treatments.
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  • Adequate Laboratory Parameters within 14 days:
  • Measurable PCNSL as diagnosed on MRI
  • Highly effective method of birth control during and after the study consistent. Men must agree to not donate sperm during and after the study. These restrictions apply for 1 year after the last dose of study drug.
  • Women of childbearing potential must have a negative serum beta-hCG or urine pregnancy test at Screening.
  • Sign of an informed consent document.The informed consent document can be signed by a person of confidence in case neurologic disorders related to the disease prevent the patient to sign himself.

Who cannot join

  • Contraindication to any excipients of the drug.
  • T-cell lymphoma.
  • Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast), prior history of systemic lymphoma, unless the patient has been free of the disease for ≥ 3 years.
  • Prior history of organ transplantation or other cause of severe immunodeficiency.
  • Major surgery, within 4 weeks prior to the first dose of study drug.
  • History of stroke or intracranial hemorrhage within 6 months prior to randomization. Patients with post-biopsies hemorrhagic sequela defined as a small hyperdense lesion < 3 mm on T2* sequence won't be excluded.
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  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists or ongoing warfarin medication or other equivalent vitamin K antagonists.
  • Any anti-platelet aggregant medication except acetyl salicylic acid ≤ 75 mg/day.
  • Requires treatment with strong CYP3A4 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 or Class 4 cardiac disease as defined by the New York Heart Association Functional Classification.
  • Vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study drug.
  • Known history of HIV or active Hepatitis C Virus (HCV; RNA polymerase chain reaction [PCR]-positive) or active Hepatitis B Virus (HBs Ag positive or DNA PCR-positive) infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.
  • Any life-threatening illness, medical condition, or organ system dysfunction which could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
  • Inability to swallow capsules.
  • Pregnancy or lactation.
  • Use of anti-cancer drug therapy within 21 days prior to the first dose of study drug.
  • Previous treatment by BTK inhibitors and PI3K inhibitors.
  • Known bleeding diathesis.
  • Inclusion in another experimental anti-cancer drug therapy*.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Patient under measure of legal protection.
  • No social security affiliation.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • CHU d'ESTAING

    Clermont-Ferrand

  • CHU de Grenoble

    Grenoble

  • CHRU de LILLE - Claude Huriez

    Lille

  • Centre Léon Bérard

    Lyon

  • CHU de la Pitié Salpêtrière

    Paris

  • CHU de la Timone

    Paris

  • CHU de Rennes

    Rennes

  • Centre Henri Becquerel

    Rouen

  • Hôpital René Huguenin Institut Curie

    Saint-Cloud

  • CHU Brabois

    Vandœuvre-lès-Nancy

Other trials in France

About this study

Official title: Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma

The study is an open label, prospective, multicenter, phase II study which aims to define ibrutinib efficacy in patients with relapsed or refractory primary central nervous lymphoma (PCNSL) or intraocular lymphoma (IOL) as measured by the disease control (DC) rate (complete response (CR) + uncertain complete response (Ru) + partial response (PR) stabilized disease (SD)) after 2 cycles of treatment according to International study group for PCNSL (IPCG) criteria.

Being tested
Ibrutinib
Keywords
PCNSL, IOL
Medical subject headings
Intraocular Lymphoma

What participants receive

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

  • IbrutinibDrug

    p.o. 560 mg once a day (four 140 mg capsules) for one year (12 cycles of 28 days)

Study groups in NCT02542514
Study groupRoleWhat they receive
IbrutinibExperimentalibrutinib in monotherapy 28 days/cycles
Receives: Drug: Ibrutinib

What is being measured

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

  1. disease control rate (CR + CRu + PR +SD)

    Disease control (DC) rate (CR + CRu + PR + SD) after 2 cycles of treatment according to IPCG criteria.

    Measured: 2 months

Secondary outcomes (7)

  1. Number of AE

    To evaluate tolerance and toxicity of ibrutinib.

    Measured: 12 months

  2. disease control

    according to IPCG criteria evaluated locally by investigators and the results of the MRI review (maximum of 6 MRI review per patient).

    Measured: 4, 6, 9 and 12 months

  3. overall response (OR)

    according to IPCG criteria evaluated locally by investigators and the results of the MRI review (maximum of 6 MRI review per patient).

    Measured: 4, 6, 9 and 12 months

  4. complete response (CR) rate

    according to IPCG criteria evaluated locally by investigators and the results of the MRI review (maximum of 6 MRI review per patient).

    Measured: 4, 6, 9 and 12 months

  5. overall survival (OS)

    according to IPCG criteria evaluated locally by investigators and the results of the MRI review (maximum of 6 MRI review per patient).

    Measured: 4, 6, 9 and 12 months

  6. time to progression

    Measured: 12 months

  7. progression-free survival (PFS)

    Measured: 12 months

Timeline

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

  1. First posted7 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionAug 2016
  4. Study completion1 Dec 2021

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
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02542514
Sponsor's protocol ID
iLOC
Acronym
iLOC
Status last verified
Apr 2022
First submitted
31 Aug 2015
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Soussain C, Choquet S, Blonski M, Leclercq D, Houillier C, Rezai K, Bijou F, Houot R, Boyle E, Gressin R, Nicolas-Virelizier E, Barrie M, Molucon-Chabrot C, Lelez ML, Clavert A, Coisy S, Leruez S, Touitou V, Cassoux N, Daniau M, Ertault de la Bretonniere M, El Yamani A, Ghesquieres H, Hoang-Xuan K. Ibrutinib monotherapy for relapse or refractory primary CNS lymphoma and primary vitreoretinal lymphoma: Final analysis of the phase II 'proof-of-concept' iLOC study by the Lymphoma study association (LYSA) and the French oculo-cerebral lymphoma (LOC) network. Eur J Cancer. 2019 Aug;117:121-130. doi: 10.1016/j.ejca.2019.05.024. Epub 2019 Jul 3.

    PubMed 31279304

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibrutinib in people with Primary Central Nervous Lymphoma and Intraocular Lymphoma, run by The Lymphoma Academic Research Organisation at 10 sites in France.

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 11 inclusion and 22 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. 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?

disease control rate (CR + CRu + PR +SD) (time frame: 2 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 NCT02542514, 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 14 Apr 2022.

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