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JOURNAL ONKOLOGIE – STUDIE
EPCORE DLBCL-3

Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma

Rekrutierend

NCT-Nummer:
NCT05660967

Studienbeginn:
März 2023

Letztes Update:
06.08.2024

Wirkstoff:
Epcoritamab, Lenalidomide

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

Geschlecht:
Alle

Altersgruppe:
Senioren (66+)

Phase:
Phase 2

Sponsor:
Genmab

Collaborator:
AbbVie

Kontakt

Genmab Trial Information
Kontakt:
Phone: +4570202728
Phone (ext.): +4570202728
E-Mail: clinicaltrials@genmab.com» Kontaktdaten anzeigen

Studienlocations
(3 von 78)

Universitaetsklinikum Freiburg
Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Aachen AOeR
Aachen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Vivantes Klinikum Neukoelln
Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Wuerzburg
Würzburg
(Bayern)
GermanyRekrutierend» Google-Maps
UW Cancer Center at ProHealth Care
53188 Waukesha
United StatesNoch nicht rekrutierend» Google-Maps
LKH - Universitätsklinikum der PMU Salzburg
Salzburg
AustriaRekrutierend» Google-Maps
AZ Turnhout - Campus Sint-Elisabeth
Turnhout
BelgiumRekrutierend» Google-Maps
Fakultni nemocnice Hradec Kralove
Hradec Králové
CzechiaRekrutierend» Google-Maps
Vseobecna fakultni nemocnice v Praze
Praha 2
CzechiaRekrutierend» Google-Maps
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac
FranceRekrutierend» Google-Maps
Clinica di Ematologia AOU Ospedali Riuniti di Ancona
Ancona
ItalyRekrutierend» Google-Maps
IRCCS Centro di Riferimento Oncologico
Aviano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna
ItalyRekrutierend» Google-Maps
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia
ItalyRekrutierend» Google-Maps
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo
ItalyRekrutierend» Google-Maps
IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST
Meldola
ItalyRekrutierend» Google-Maps
IEO Istituto Europeo di Oncologia Parent
Milano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Vincenzo Cervello
Palermo
ItalyRekrutierend» Google-Maps
AUSL Piacenza Ospedale Guglielmo da Saliceto
Piacenza
ItalyRekrutierend» Google-Maps
Azienda sanitaria integrata università di Trieste
Trieste
ItalyRekrutierend» Google-Maps
National Cancer Center Hospital East
Kashiwa
JapanRekrutierend» Google-Maps
Keimyung University Dongsan Hospital
Daegu
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Jeonbuk National University Hospital
Jeonju
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
Seoul
Korea, Republic ofRekrutierend» Google-Maps
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
Biała Podlaska
PolandRekrutierend» Google-Maps
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona
SpainRekrutierend» Google-Maps
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon
Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Fundacion Jimenez Diaz
Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Nuestra Señora de Valme
Sevilla
SpainRekrutierend» Google-Maps
Hospital Universitario Puerta del Mar
Sevilla
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen Macarena
Sevilla
SpainRekrutierend» Google-Maps
Bristol Haematology and Oncology Centre
Bristol
United KingdomZurückgezogen» Google-Maps
Royal Marsden Hospital - Fulham
London
United KingdomNoch nicht rekrutierend» Google-Maps
Southampton General Hospital
Southampton
United KingdomRekrutierend» Google-Maps
Royal Marsden Hospital
Sutton
United KingdomNoch nicht rekrutierend» Google-Maps
Royal Cornwall Hospital NHS Trust
Truro
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This is an open-label, multicenter, global phase-2 trial evaluating the efficacy and

safety of epcoritamab monotherapy and epcoritamab plus lenalidomide in elderly patients

who are deemed anthracycline ineligible.

The trial is designed in two stages:

- Stage 1 which includes a safety run-in phase in each arm

- Stage 2, an expansion of the selected treatment from Stage 1

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Must have newly diagnosed CD20+ large cell lymphoma.

- Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to:

- Being age ≥80 years; AND/OR

- Being age ≥75 years and having important comorbid condition(s), which are

likely to have a negative impact on tolerability of anthracycline-based

therapy/cytotoxic chemotherapy.

- Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of

10.

- Have Ann Arbor Stage II-IV disease.

- Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is

attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening

phase results in an improvement of ECOG PS to ≤2 prior to enrollment).

- Have measurable disease as per Lugano criteria.

- Have acceptable organ function based on baseline bloodwork.

- Must have fresh (preferred) or archival biopsy material at screening.

Exclusion Criteria:

- Has known active, clinically significant bacterial, viral, fungal, mycobacterial,

parasitic, or other infection at trial enrollment, including COVID-19 infection.

- Has severe cardiovascular disease (other than those eligibility criteria that

preclude the subject from receiving anthracycline-based therapy/cytotoxic

chemotherapy),

- Has been exposed to/received any of the following prior therapies, treatments, or

procedures within the specified timeframes:

- Major surgery within 4 weeks prior to the first dose of epcoritamab;

- Non-investigational antineoplastic agents (except anti-CD20 monoclonal

antibodies) or any investigational drug within 4 weeks or 5 half-lives,

whichever is shorter, prior to the first dose of epcoritamab;

- Autologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic

stem cell transplantation, or solid organ transplantation;

- Live, attenuated vaccines within 30 days prior to initiation of epcoritamab;

- Investigational vaccines within 28 days before the planned first dose of

epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and

therapies are not allowed);

- Invasive investigational medical device use within 28 days before the planned

first dose of epcoritamab.

- Has primary central nervous system (CNS) tumor or known CNS involvement or

intracranial involvement as confirmed by mandatory brain magnetic resonance

imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated,

by lumbar puncture.

- Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure

within 6 months of signing an informed consent form.

- Has known past or current malignancy other than inclusion diagnosis, with exceptions

as stated in protocol.

- Has known or suspected allergies, hypersensitivity, or intolerance to either of the

trial treatments or has known or suspected contraindication to the use of all

locally available anti-cytokine therapies per local guidelines for management of

cytokine release syndrome (CRS).

- Has active hepatitis B virus (HBV) (DNA polymerase chain reaction [PCR]-positive) or

hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or

cirrhosis.

- Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment.

- Has suspected active or inadequately treated latent tuberculosis.

- Has a known history of seropositivity for HIV. Note: HIV testing is required at

screening only if required per local health authorities or institutional standards.

Note: Other protocol defined inclusion/exclusion criteria may apply.

Studien-Rationale

Primary outcome:

1. Complete Response (CR) rate (Time Frame - From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years):
Percentage of participants achieving CR. Assessed by the Investigator per Lugano criteria



Secondary outcome:

1. Duration of response (DOR) (Time Frame - From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years):
Defined as the time between date of first response to the date of first documented tumor progression or death (due to any cause) whichever occurs first

2. Duration of complete response (DOCR) (Time Frame - From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years):
Defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first

3. Time to response (TTR) (Time Frame - From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 1 year):
Defined as the time from first dose to first documentation of objective tumor response (CR or PR)

4. Overall Response Rate (ORR) (Time Frame - From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years):
Defined as the percentage of patients who achieve best overall response of complete response (CR) or partial response (PR) determined by Lugano criteria

5. Progression-free survival (PFS) (Time Frame - From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years):
Defined as the time from first dose to date of PD or death (due to any cause) whichever occurs first

6. Time to next anti-lymphoma therapy (TTNT) (Time Frame - From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years):
Defined as the time from first dose to administration of subsequent anti-lymphoma therapy

7. Rate of minimal residual disease (MRD) negativity (Time Frame - From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years):
Percentage of participants with at least 1 post-screening MRD negative result

8. Overall survival (OS) (Time Frame - From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 3 years):
Defined at the timeframe from first dose to death

9. Incidence and severity of adverse events (AEs) (Time Frame - From screening until end of the safety follow-up period (60 days after last dose)):
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment

10. Incidence of clinically significant shifts in laboratory parameters (Time Frame - From screening until end of the safety follow-up period (60 days after last dose)):
Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, cardiac enzymes, immunoglobulins, and urinalyses

11. Incidence of anti-drug antibodies (ADAs) to epcoritamab in plasma (Time Frame - From first dose until treatment discontinuation (assessed up to 12 months)):
To evaluate immunogenicity

12. Evaluate patient-reported outcomes (PROs) related to lymphoma symptoms (Time Frame - From cycle 1, day 1 until 90 days after last dose (each cycle is 28 days)):
Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym). Scale from 0-168 obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life

13. Assess pharmacokinetics (PK) of epcoritamab (Time Frame - From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months)):
Total body clearance of drug from the plasma (CL)

14. Assess pharmacokinetics (PK) of epcoritamab (Time Frame - From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months)):
Maximum observed concentration (Cmax)

15. Assess pharmacokinetics (PK) of epcoritamab (Time Frame - From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months)):
Time to reach Cmax (Tmax)

16. Assess pharmacokinetics (PK) of epcoritamab (Time Frame - From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months)):
Terminal Elimination Half-Life (t 1/2)

Studien-Arme

  • Experimental: Epcoritamab monotherapy
  • Experimental: Epcoritamab in combination with lenalidomide

Geprüfte Regime

  • Epcoritamab (GEN3013 / DuoBody®-CD3×CD20 / EPKINLY™ / ):
    Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.
  • Lenalidomide (Revlimid®):
    Lenalidomide will be administered orally (capsules; starting dose of 10 or 20 mg) once daily on Day 1 to Day 21 of each 28-day cycle for up to 12 cycles.

Quelle: ClinicalTrials.gov


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