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Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 294 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Sep 1, 2026 to Jul 30, 2026 Completion pushed from Dec 1, 2027 to Jun 15, 2028 · Study description expanded, about 18 words · Eligibility criteria shortened, about 5 words Show 3 more changesShow less
    • Completion pushed from Dec 1, 2027 to Jun 15, 2028
    • Study description expanded, about 18 words
    • Eligibility criteria shortened, about 5 words
  2. 10 versions Re-verified since Apr 24, 2026, no change to tracked fieldsv284-v293
  3. Trial status changed: Recruiting → Active, Not Recruiting Primary completion pushed from Jun 15, 2026 to Sep 1, 2026 · Enrollment reduced: 93 → 68 participants · Completion pushed from Jun 15, 2027 to Dec 1, 2027 · 1 morev283 Show 4 more changesShow less
    • Primary completion pushed from Jun 15, 2026 to Sep 1, 2026
    • Enrollment reduced: 93 → 68 participants
    • Completion pushed from Jun 15, 2027 to Dec 1, 2027
    • Site details revised
  4. 5 versions Re-verified since Dec 31, 2025, no change to tracked fieldsv278-v282
  5. Study Status, Study Description, Eligibility, Contacts/Locationsv277
Show 32 earlier versionsHide 32 earlier versions
  1. 7 versions Re-verified since Jul 10, 2025, no change to tracked fieldsv270-v276
  2. Primary completion date: Jun 15, 2025 to Jun 15, 2026v269
  3. 9 versions Re-verified since Feb 26, 2025, no change to tracked fieldsv260-v268
  4. Trial status: Suspended to Recruiting Enrollment target: 53 to 93 · Site details revisedv259 Show 2 more changesShow less
    • Enrollment target: 53 to 93
    • Site details revised
  5. 3 versions Re-verified since Jan 31, 2025, no change to tracked fieldsv256-v258
  6. Trial status: Recruiting to Suspended Sponsor's reason: On administrative hold pending an amendment. Enrollment target: estimated 93 to confirmed 53v255 Show 1 more changeShow less
    • Enrollment target: estimated 93 to confirmed 53
  7. 10 versions Re-verified since Oct 23, 2024, no change to tracked fieldsv245-v254
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
BACKGROUND: * Primary CNS lymphoma (PCNSL) is a rare subtype of diffuse large B-cell lymphoma. * The outcome for patients with this diagnosis is significantly worse than for that of systemic DLBCL. Most treatment approaches in the past have included high dose methotrexate and radiation treatment. * Most PCNSLs appear to be of activated B-cell (ABC) origin. * Ibrutinib is an inhibitor of Bruton s tyrosine kinase (BTK) and effective for systemic DLBCL of ABC origin. * We propose doing a study in which ibrutinib is combined with a novel chemotherapy platform called dose adjusted temozolomide, etoposide, doxil, dexamethasone, ibrutinib, rituximab (TEDDI-R). OBJECTIVE: \- Identify the maximum tolerated dose (MTD) of ibrutinib or the dose that achieves adequate CSF concentrations, whichever comes first, when ibrutinib is given with TEDDI-R. ELIGIBILITY: * Relapsed/refractory PCNSL. * Age greater than or equal to 18 years. * No pregnant or breast-feeding women. * Adequate organ function (defined in protocol). STUDY DESIGN: * This is a phase 1 study of 40 patients. * The study will have two components. 1. Phase 1: MTD of ibrutinib will be identified or the dose at which ibrutinib achieves a concentration of less than or equal to 100 nM in the CSF, when given in combination with TEDDI-R immuno-chemotherapy, whichever comes first. 2. Expansion cohort: Safety and tolerability of the regimen in relapsed/refractory or previously untreated PCNSL (DLBCL type) will be assessed at the final ibrutinib dose with TEDDI-R in 10 patients. Secondary objectives will be PFS and OS.
Trial Details
NCT Number NCT02203526
Lead Sponsor National Cancer Institute (NCI)
Conditions Primary Central Nervous System Lymphoma
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov