Montag, 29. April 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
ZUMA-23

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

Rekrutierend

NCT-Nummer:
NCT05605899

Studienbeginn:
Februar 2023

Letztes Update:
25.04.2024

Wirkstoff:
Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Etoposide, Rituximab, Doxorubicin, Vincristine, Prednisone

Indikation (Clinical Trials):
Lymphoma, Lymphoma, B-Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Kite, A Gilead Company

Collaborator:
-

Studienleiter

Kite Study Director
Study Director
Kite, A Gilead Company

Kontakt

Studienlocations
(3 von 63)

Helios Klinikum Berlin-Buch
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Charite Universitaetsmedizin Berlin
Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitätsklinik Erlangen
Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
University of Alabama Hospital
35233 Birmingham
United StatesRekrutierend» Google-Maps
Banner MD Anderson Cancer Center
85234 Gilbert
United StatesRekrutierend» Google-Maps
UC San Diego Moores Cancer Center
92093 La Jolla
United StatesRekrutierend» Google-Maps
University of California Los Angeles (UCLA)
90025 Los Angeles
United StatesRekrutierend» Google-Maps
Stanford Cancer Institute
94305 Palo Alto
United StatesRekrutierend» Google-Maps
Colorado Blood Cancer Institute
80218 Denver
United StatesRekrutierend» Google-Maps
Georgia Cancer Center at Augusta University
30912 Augusta
United StatesRekrutierend» Google-Maps
Northwestern Memorial Hospital
60612 Chicago
United StatesRekrutierend» Google-Maps
University of Chicago Medical Center
60637 Chicago
United StatesRekrutierend» Google-Maps
The University of Kansas Hospital
66205 Westwood
United StatesRekrutierend» Google-Maps
Ochsner Clinic Foundation
70121 New Orleans
United StatesRekrutierend» Google-Maps
University of MD Greenebaum Comprehensive Cancer Center
21201 Baltimore
United StatesRekrutierend» Google-Maps
Dana-Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-Maps
University of Michigan
48109 Ann Arbor
United StatesRekrutierend» Google-Maps
Mayo Clinic Cancer Center Outpatient Pharmacy
55902 Rochester
United StatesRekrutierend» Google-Maps
John Theurer Cancer Center at Hackensack University Medical Center
07601 Hackensack
United StatesRekrutierend» Google-Maps
Montefiore Medical Center
10467 Bronx
United StatesRekrutierend» Google-Maps
Roswell Park Cancer Institute
14203 Buffalo
United StatesRekrutierend» Google-Maps
Weill Cornell Medical College - NewYork Presbyterian Hospital
10021 New York
United StatesRekrutierend» Google-Maps
Columbia University Medical Center
10032 New York
United StatesRekrutierend» Google-Maps
University of Rochester Medical Center
14642 Rochester
United StatesRekrutierend» Google-Maps
Avera Cancer Institute
57105 Sioux Falls
United StatesRekrutierend» Google-Maps
Tennessee Oncology, PLLC
37203 Nashville
United StatesRekrutierend» Google-Maps
Henry-Joyce Cancer Center
37232 Nashville
United StatesRekrutierend» Google-Maps
University of Texas Southwestern Medical Center
75235 Dallas
United StatesRekrutierend» Google-Maps
The University of Texas, MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Fred Hutchinson Cancer Center
98109 Seattle
United StatesRekrutierend» Google-Maps
Royal Prince Alfred Hospital
2050 Camperdown
AustraliaRekrutierend» Google-Maps
Royal Brisbane and Women's Hospital
4101 South Brisbane
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Center
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Medizinische Universität Innsbruck
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
5020 Salzburg
AustriaRekrutierend» Google-Maps
Medizinische Universität Wien (AKH Wien, Medical University Vienna and General Hospital Vienna)
01090 Vienna
AustriaRekrutierend» Google-Maps
The Ottowa Hospital- General Campus
K1H 8L6 Ottawa
CanadaRekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaAktiv, nicht rekrutierend» Google-Maps
Hopital Claude Huriez CHU Lille, Service Maladies du sang
59037 Lille cedex
FranceRekrutierend» Google-Maps
Hopital Saint Eloi
34295 Montpellier CEDEX 05
FranceRekrutierend» Google-Maps
IRCCS Azienda Ospedaliero-Universitaria di Bologna
40138 Bologna
ItalyRekrutierend» Google-Maps
Academisch Medisch Centrum
1081HV Amsterdam
NetherlandsRekrutierend» Google-Maps
University Medical Center Groningen
9700 RB Groningen
NetherlandsRekrutierend» Google-Maps
Universitair Medisch Centrum Utrecht
3508 GA Utrecht
NetherlandsRekrutierend» Google-Maps
Centro Hospitalar Universitario Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon
PortugalRekrutierend» Google-Maps
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - E.P.E.
Lisbon
PortugalRekrutierend» Google-Maps
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
4200-072 Porto
PortugalRekrutierend» Google-Maps
Hospital Universitari Vall D'Hebron
8035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Hospital Clínico Universitario de Valencia
46010 Valencia
SpainRekrutierend» Google-Maps
Addenbrookes Hospital (Cambridge University Hospitals NHS Foundation Trust)
B15 2TH Birmingham
United KingdomRekrutierend» Google-Maps
University Hospitals Southampton
SO16 6YD Southampton
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Five years after randomization, participants who have received axicabtagene ciloleucel will

transition to a separate long-term follow-up study (study KT-US-982-5968) to complete the

remainder of the 15-year follow-up assessments.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

- Histologically confirmed large B cell lymphoma (LBCL) based on 2016 World Health

Organization (WHO) classification by local pathology lab assessment, including of the

following:

- Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)

- High-grade B-cell lymphoma (HGBL)

- Note: Transformed DLBCL from follicular lymphoma or from marginal zone lymphoma is

eligible if no prior treatment with anthracycline-containing regimen.

- High-risk disease defined as an International Prognostic Index (IPI) score of 4 or 5

at initial diagnosis.

- Have received only 1 cycle of rituximab plus chemotherapy (R-chemotherapy).

- Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.

- Females of childbearing potential must have a negative serum or urine pregnancy test.

Key Exclusion Criteria:

- The following WHO 2016 subcategories by local assessment:

- T-cell/histiocyte-rich LBCL

- Primary DLBCL of the central nervous system (CNS)

- Primary mediastinal (thymic) LBCL

- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and

classical Hodgkin lymphoma

- Burkitt lymphoma

- History of Richter's transformation of chronic lymphocytic leukemia

- Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or

a history of CNS involvement of lymphoma.

- Presence of cardiac lymphoma involvement.

- Any prior treatment for LBCL other than the 1 cycle of R-chemotherapy.

- History of severe immediate hypersensitivity reaction to any of the agents used in

this study.

- Presence of CNS disorder. History of stroke, transient ischemic attack, or posterior

reversible encephalopathy syndrome (PRES) within 12 months prior to enrollment.

- History of acute or chronic active hepatitis B or C infection.

- Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV

medications, with an undetectable viral load by PCR and with a cluster of

differentiation 4 (CD4) count > 200 cells/uL.

- Medical conditions or residual toxicities from prior therapies likely to interfere

with assessment of safety or efficacy of study treatment. Please refer to protocol for

further details.

- History of clinically significant cardiac disease within 12 months before enrollment.

- History of any medical condition requiring maintenance systemic

immunosuppression/systemic disease modifying agents within the last 2 years.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Studien-Rationale

Primary outcome:

1. Event-free Survival (EFS) by Blinded Central Assessment (Time Frame - Up to 5 years):
EFS, is defined as the time from randomization to the earliest occurrence of death due to any cause, disease progression/relapse, initiation of any non-protocol specified subsequent new lymphoma therapy for the treatment of residual disease or Biopsy-proven residual disease at the Month 6 disease assessment or later, regardless of whether subsequent new lymphoma therapy is initiated or not.



Secondary outcome:

1. Progression-free Survival (PFS) by Blinded Central Assessment (Time Frame - Up to 5 years):
PFS is defined as the time from randomization to disease progression or death due to any cause.

2. Overall Survival (Time Frame - Up to 5 years):
OS is defined as the time from randomization to death due to any cause.

3. PFS by Investigator Assessment (Time Frame - Up to 5 years):
PFS is defined as the time from randomization to disease progression or death due to any cause.

4. Complete Response (CR) Rate by Blinded Central Assessment (Time Frame - Up to 5 years):
CR rate is defined as the proportion of participants who have achieved CR per Lugano classification after treatment completion and prior to subsequent new off protocol anti-lymphoma therapy.

5. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths (Time Frame - First dose date up to 5 years plus 30 days)

6. Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values (Time Frame - First dose date up to 5 years plus 30 days)

7. Change From Baseline in the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30) Score (Time Frame - Baseline, Month 18):
The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content: five (5) multi-item functional scales, three (3) multi-item symptom scales, six (6) symptom single-item scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL). Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.

8. Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Hodgkin Lymphoma High Grade Module (EORTC QLQ-NHL-HG29) Score (Time Frame - Baseline, Month 18):
The EORTC QLQ-NHL-HG29 is a 29-item patient-reported assessment measuring patients' high-grade NHL-specific symptoms and functioning. The 29 items assess symptom burden due to disease and/or treatment, fatigue/physical condition, neuropathy, emotional impacts, and worries/fears health and functioning. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.

9. Change From Baseline in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L) Score (Time Frame - Baseline, Month 18):
The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.

Studien-Arme

  • Experimental: Axicabtagene Ciloleucel
    Participants will receive cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV lymphodepletion chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.
  • Active Comparator: Standard of Care Therapy
    Participants will receive the investigator's choice of one of the following therapies/dosing schedules: Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for a total of 6 cycles (21-day cycle) Rituximab 375 mg/m^2 on Day 1 Cyclophosphamide 750 mg/m^2 on Day 1 Doxorubicin 50 mg/m^2 on Day 1 Vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1 Prednisone 40 mg/m^2 on Day 1 through Day 5 Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) for a total of 6 cycles (21-day cycle) Rituximab 375 mg/m^2 on Day 1 Etoposide 50 mg/m^2 on Days 1 to 4 Doxorubicin 10 mg/m^2 on Days 1 to 4 Vincristine 0.4 mg/m^2 on Days 1 to 4 Cyclophosphamide 750 mg/m^2 on Day 5 Prednisone 60 mg/m^2 twice daily on Days 1 to 5

Geprüfte Regime

  • Axicabtagene Ciloleucel (Yescarta® / Axi-cel / ):
    A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
  • Cyclophosphamide:
    Administered intravenously
  • Fludarabine:
    Administered intravenously
  • Etoposide:
    Administered intravenously
  • Rituximab:
    Administered intravenously
  • Doxorubicin:
    Administered intravenously
  • Vincristine:
    Administered intravenously
  • Prednisone:
    Administered orally

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.