Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Kite, A Gilead Company
Study ID
NCT04002401
Phase
PHASE2
Status
Completed

Conditions

  • Refractory Large B-cell Lymphoma

Eligibility Criteria

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

Interventions

  • Axicabtagene Ciloleucel — BIOLOGICAL
    A single infusion of CAR-transduced autologous T cells administered intravenously
  • Rituximab — DRUG
    Administered intravenously
  • Fludarabine — DRUG
    Administered according to package insert
  • Cyclophosphamide — DRUG
    Administered according to package insert

Study Details

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.

Key Dates

Start date
Nov 5, 2019
Status verified
Feb 2024
Primary completion
Jan 30, 2023
Completion
Jan 30, 2023

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Axicabtagene Ciloleucel and Rituximab Combination
    Participants will receive rituximab 375 mg/m\^2, once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-cluster of differentiate 19 (CD19) chimeric antigen receptor (CAR) T cells/kg once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, once every 28 days starting from Day 21 up to Day 133.

Primary Outcome Measure

Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators [ Time Frame: First infusion date up to maximum duration of 32.7 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
City of Hope National Medical CenterDuarteCalifornia91010-3012-
Stanford Cancer InstitutePalo AltoCalifornia94305-
UCLA Hematology/OncologySanta MonicaCalifornia90404-
Mayo Clinic FloridaJacksonvilleFlorida32224-
University of Chicago Medical CenterChicagoIllinois60637-
Loyola University Medical CenterMaywoodIllinois60153-
Mayo ClinicRochesterMinnesota55905-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Columbia University Medical Center, New York Presbyterian HospitalNew YorkNew York10032-
Vanderbilt University Medical CenterNashvilleTennessee37232-
St. David's South Austin Medical CenterAustinTexas78704-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZCity of Hope National Medical Center· Duarte, CAStanford Cancer Institute· Palo Alto, CAUCLA Hematology/Oncology· Santa Monica, CAMayo Clinic Florida· Jacksonville, FLUniversity of Chicago Medical Center· Chicago, IL

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