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Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE
TRANSCEND FL

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

Rekrutierend

NCT-Nummer:
NCT04245839

Studienbeginn:
Juli 2020

Letztes Update:
01.02.2021

Wirkstoff:
Fludarabine, Cyclophosphamide, JCAR017

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Celgene

Collaborator:
-

Studienleiter

Thalia Farazi, M.D./Ph.D
Study Director
Celgene Medical Director

Kontakt

Associate Director Clinical Trial Disclosure
Kontakt:
Phone: 1-888-260-1599
E-Mail: clinicaltrialdisclosure@celgene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 38)

Universitatsklinikum Koeln
50937 Koeln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
LMU Klinikum der Universitat Muenchen
81377 Munich
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Yale New Haven Health - Smilow Cancer Hospita
06510 New Haven
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Alexandra Dormal, RN BSN
Phone: 203-833-2701
E-Mail: Alexandra.dormal@yale.edu

Pavan Anant
E-Mail: pavan.anant@yale.edu
» Ansprechpartner anzeigen
Northwestern University - Robert H. Lurie Comprehensive Cancer Center
60611 Chicago
United StatesRekrutierend» Google-Maps
University of Maryland - Greenebaum Comprehensive Cancer Center
21201 Baltimore
United StatesRekrutierend» Google-Maps
Massachusetts General Hospital - Dana-Farber Cancer Institute (The Jon and JoAnn Hagler Center for Lymphoma)
02114 Boston
United StatesRekrutierend» Google-Maps
Beth Israel Deaconess Medical Center
02215 Boston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jon Arnason,, MD
Phone: 617-667-9920
E-Mail: jarnason@bidmc.harvard.edu

Pavania Elavalakanar
Phone: 617-667-1903
E-Mail: pelavala@bidmc.harvard.edu
» Ansprechpartner anzeigen
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesNoch nicht rekrutierend» Google-Maps
Novant Health Cancer Specialists Charlotte
28204 Charlotte
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Alan Skarbnik, MD
Phone: 704-316-3297
E-Mail: azskarbnik@novanthealth.org

Kunal Shah
Phone: 704-384-8823
E-Mail: kashah@novanthealth.org
» Ansprechpartner anzeigen
Providence Cancer Center - Earle A. Chiles Research Institute
97213 Portland
United StatesRekrutierend» Google-Maps
Perelman Center for Advanced Medicine - Abramson Cancer Center University of Pennsylvania
19104 Philadelphia
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Michael McNicholas, RN
E-Mail: Michael.McNicholas@pennmedicine.upenn.edu

Tanya Latorre, RN
E-Mail: Tanya.Latorre@pennmedicine.upenn.edu
» Ansprechpartner anzeigen
Avera Research Institute
57105 Sioux Falls
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Lauren Brandt, RN
Phone: 888-422-1410
E-Mail: hematologyresearch@avera.org

Lisa Jackson, RN
Phone: 888-422-1410
E-Mail: hematologyresearch@avera.org
» Ansprechpartner anzeigen
University of Virginia Health System
22908 Charlottesville
United StatesRekrutierend» Google-Maps
Fred Hutchinson Cancer Research Center
98109 Seattle
United StatesNoch nicht rekrutierend» Google-Maps
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien
1090 Wien
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Ulrich Jaeger
Phone: +43114040044090
E-Mail: ulrich.jaeger@meduniwien.ac.at

Mercedes Litzenberger
Phone: +4314040044100
E-Mail: mercedes.litzenberger@meduniwien.ac.at
» Ansprechpartner anzeigen
Hospital Maisonneuve - Rosemont
H1T 2M4 Quebec
CanadaNoch nicht rekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 2M9 Ontario
CanadaRekrutierend» Google-Maps
CIUSSS de l'Est-de-l'Ile-de-Montreal - Installation Hopital Maisonneuve-Rosemont
Quebec
CanadaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Olivier Cormier, MD
E-Mail: olivier.cormier.cemtl@ssss.gouv.qc.ca

Mathilde Prunier
E-Mail: mathilde.prunier.cemtl@ssss.gouv.qc.ca
» Ansprechpartner anzeigen
CHRU-Hopital Claude Huriez
59037 Lille
FranceNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Fanny Joly
Phone: +33320444022
E-Mail: fanny.joly@chru.lille.fr

Alexandre Nung
Phone: +33320444022
E-Mail: alexandre.nung@chru-lille.fr
» Ansprechpartner anzeigen
CHU Montpellier - Hôpital Saint Eloi
34295 Montpellier
FranceRekrutierend» Google-Maps
Ansprechpartner:
Cecile Popko
Phone: +33467338366
E-Mail: c-popko@chu-montpellier.fr

Marguerite Lepicard
Phone: +33467335379
E-Mail: m-lepicard@chu-montpellier.fr
» Ansprechpartner anzeigen
Centre Hospitalier Lyon-Sud
69495 Pierre-Benite
FranceRekrutierend» Google-Maps
Azienda Ospedaliera Papa Giovanni XXIII
24127 Bergamo
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
80131 Naples
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Mariangela Saggese, Pharm D.
Phone: +39 0 81 5903 2014
E-Mail: m.saggese@istitutotumori.na.it

Gianpaolo Marcacci, MD
Phone: +39 0 81 5903 204
E-Mail: g.marcacci@istitutotumori.na.it
» Ansprechpartner anzeigen
National Cancer Center Hospital
105-8470 Chuo-ku
JapanRekrutierend» Google-Maps
Kyushu University Hospital
812-8582 Fukuoka
JapanNoch nicht rekrutierend» Google-Maps
Hokkaido University Hospital
060-8648 Sapporo-shi
JapanRekrutierend» Google-Maps
Universitario de Salamanca - Hospital Clinico
37007 Salamanca
SpainRekrutierend» Google-Maps
Ansprechpartner:
Laura Prieto Garcia
Phone: 0034 92329 1100
Phone (ext.): 55974
E-Mail: lprietog@saludcastillayleon.es

Eva Diez Baeza
Phone: 0034 92391100
Phone (ext.): 55974
E-Mail: ediez.ibsal@saludcastillayleon.es
» Ansprechpartner anzeigen
Hospital Universitario Virgen del Rocio
41013 Sevilla
SpainRekrutierend» Google-Maps
Ansprechpartner:
Juan Luis Reguera Ortega
Phone: +34955013277
E-Mail: juanl.reguera.sspa@juntadeandalucia.es

Estefania Menendez
Phone: +34955013277
E-Mail: estefania.menendez@juntadeandalucia.es
» Ansprechpartner anzeigen
Karolinska University Hospital
S- 141 86 Stockholm
SwedenNoch nicht rekrutierend» Google-Maps
University College London Hospitals NHS Foundation Trust - University College Hospital
NW1 2PG London
United KingdomNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Leigh Wood
Phone: 0790839901
E-Mail: leigh.wood@nhs.net

Clemency Every-Clayton
Phone: 7779560148
E-Mail: clemency.every-clayton@nhs.net
» Ansprechpartner anzeigen
The Christie NHS Foundation Trust
M20 4BX Withington
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate

efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.

The study will be conducted in compliance with the International Council on Harmonisation

(ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good

Clinical Practice (GCP) and applicable regulatory requirements.

This study is divided into three periods:

- Pretreatment, which consists of screening assessments, leukapheresis and the

Pretreatment evaluation;

- Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and

continues through JCAR017 administration at Day 1 with follow-up through Day 29;

- Posttreatment, which includes follow-up assessments for disease status and safety for 2

years.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone

lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by

local pathology

2. Patients should have received at least one prior therapy that includes anti-CD20 and

alkylating agent

3. Follicular lymphoma patients: Received at least one prior line of systemic therapy.

Patients that received one or two prior lines of systemic therapy are eligible if they

present with high risk features. Patients that received three or more prior lines of

systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and

alkylating agent (as listed in criterion 2)

4. Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy,

assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in

criterion 2)

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

6. Adequate organ function

7. Adequate vascular access for leukapheresis procedure

Exclusion Criteria:

1. Evidence of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed

FL

2. WHO subclassification of duodenal-type FL

3. Central nervous system-only involvement by malignancy (subjects with secondary central

nervous system (CNS) involvement are allowed on study)

4. History of another primary malignancy that has not been in remission for at least 2

years, with the exception of non-invasive malignancies

5. Prior CAR T-cell or other genetically-modified T-cell therapy

6. History of or active human immunodeficiency virus (HIV)

7. Active hepatitis B or active hepatitis C

8. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate

antibiotics or other treatment

9. Active autoimmune disease requiring immunosuppressive therapy

10. Presence of acute or chronic graft-versus-host=disease

11. History of significant cardiovascular disease

12. History or presence of clinically relevant central nervous system pathology

Studien-Rationale

Primary outcome:

1. Complete Response Rate (CRR) (Time Frame - Up to 24 months):
is defined as the percentage of subjects achieving a complete response (CR) at any time up to 24 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification".



Secondary outcome:

1. Overall response rate (ORR) as assessed by PET-CT and/or CT using "The Lugano Classification" (Time Frame - Up to 24 months):
is defined as the percentage of subjects achieving a response (CR or PR) at any time up to 24 months after JCAR017 treatment

2. Duration of response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification" (Time Frame - Up to 24 months):
is defined for subjects with a BOR of CR as the time from first response (CR or PR) to disease progression or death from any cause up to 24 months after JCAR017 treatment

3. Duration of response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification" (Time Frame - Up to 24 months):
is defined as the time from first response (CR or PR) to disease progression or death from any cause, whichever occurs first up to 24 months after JCAR017 treatment

4. Progression-free survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification" (Time Frame - Up to 24 months):
is defined as the time from start of JCAR017 to disease progression or death from any cause, whichever occurs first up to 24 months after JCAR017 treatment

5. Overall Survival (OS) (Time Frame - Up to 24 months):
is defined as the time from start of JCAR017 to time of death due to any cause up to 24 months after JCAR017 treatment

6. Adverse Events (AEs) (Time Frame - Up to 24 months):
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

7. Pharmacokinetics - Cmax (Time Frame - Up to 24 months):
Maximum concentration

8. Pharmacokinetics - Tmax (Time Frame - Up to 24 months):
Time to maximum concentration

9. Pharmacokinetics - AUC (Time Frame - Up to 24 months):
Area under the curve

10. European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) (Time Frame - Up to 24 months):
is questionnaire that will be used as a measure of health-related quality of life. The EORTC QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.

11. Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS) (Time Frame - Up to 24 months):
is a 15-item lymphoma-specific additional concerns subscale. This subscale addresses symptoms and functional limitations are important to lymphoma patients. The FACT-LymS items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. High scores indicate lower symptom burden.

Geprüfte Regime

  • Fludarabine:
    Fludarabine
  • Cyclophosphamide:
    Cyclophosphamide
  • JCAR017:
    JCAR017

Quelle: ClinicalTrials.gov


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