Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or In… (NCT02542514) | Clinical Trial Compass
CompletedPhase 2
Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma
France52 participantsStarted 2015-09
Plain-language 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 (Ru) + partial response (PR) stabilized disease (SD)) after 2 cycles of treatment according to International study group for PCNSL (IPCG) criteria.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Adequate Laboratory Parameters within 14 days:
✓. Measurable PCNSL as diagnosed on MRI
Exclusion criteria
✕. 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.
What they're measuring
1
disease control rate (CR + CRu + PR +SD)
Timeframe: 2 months
Trial details
NCT IDNCT02542514
SponsorThe Lymphoma Academic Research Organisation
✕. 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.
✕. Requires anticoagulation with warfarin or equivalent vitamin K antagonists or ongoing warfarin medication or other equivalent vitamin K antagonists.