Study of Tisagenlecleucel in Combination With Ibrutinib in r/r Diffuse Large B-cell Lymphoma Patients

Part of paid clinical trials in Tampa, Florida.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03876028
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tisagenlecleucel — BIOLOGICAL
    Infusion
  • Ibrutinib — DRUG
    Oral (tablets or capsules)

Study Details

A multi-center, open-label, phase Ib study to evaluate the safety and tolerability of the administration of tisagenlecleucel in combination with ibrutinib in patients with r/r DLBCL who have received two or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy, and who have progressed after or are not candidates for ASCT.

Key Dates

Start date
Jun 11, 2019
Status verified
Jan 2023
Primary completion
Nov 1, 2021
Completion
Nov 1, 2021

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib (before leukapheresis) + Tisagenlecleucel
    Patients will start ibrutinib treatment before leukapheresis
  • Experimental: Ibrutinib (after leukapheresis) + Tisagenlecleucel
    Patients will start ibrutinib treatment after leukapheresis.

Primary Outcome Measure

Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 24 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19104-

Find similar trials in Tampa, FL

By research site
H Lee Moffitt Cancer Center and Research Institute· Tampa, FLUniversity of Pennsylvania, Abramson Cancer Center· Philadelphia, PA

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