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JOURNAL ONKOLOGIE – STUDIE
ALLELE

Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy

Rekrutierend

NCT-Nummer:
NCT03394365

Studienbeginn:
Dezember 2017

Letztes Update:
18.06.2021

Wirkstoff:
tabelecleucel

Indikation (Clinical Trials):
Lymphoproliferative Disorders

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
Atara Biotherapeutics

Collaborator:
-

Studienleiter

Hema Parmar, PhD
Study Director
Atara Biotherapeutics

Kontakt

Studienlocations
(3 von 64)

University of California San Diego Moores Cancer Center (Adults only)
92093 La Jolla
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Carolyn Mulroney, MD
Phone: 858-822-8273
E-Mail: camulroney@ucsd.edu
» Ansprechpartner anzeigen
Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)
90027 Los Angeles
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Neena Kapoor, MD
Phone: 323-361-2434
E-Mail: nkapoor@chla.usc.edu
» Ansprechpartner anzeigen
University of California Davis Comprehensive Cancer Center (Adults only)
95817 Sacramento
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Mehrdad Abedi, MD
Phone: 916-703-9118
E-Mail: mabedi@ucdavis.edu
» Ansprechpartner anzeigen
MedStar Georgetown University Hospital (Adults and Pediatrics)
20007 Washington
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Udeme Ekong, MD
Phone: 202-444-3514
E-Mail: udeme.d.ekong@gunet.georgetown.edu
» Ansprechpartner anzeigen
University of Florida (Adults and Pediatrics)
32610 Gainesville
United StatesAbgeschlossen» Google-Maps
University of Miami/Jackson Memorial Hospital (Adults only)
33136 Miami
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Amer Beitinjaneh, MD, MPH, MSc
Phone: 305-243-9848
E-Mail: abeitinjaneh@miami.edu
» Ansprechpartner anzeigen
Children's Healthcare of Atlanta at Egleston (Pediatrics)
30322-1060 Atlanta
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Lakshmanan Krishnamurti, MD
Phone: 404-785-1112
E-Mail: lakshmanan.krishnamurti@choa.org
» Ansprechpartner anzeigen
Winship Cancer Institute of Emory University (Adults only)
30322 Atlanta
United StatesAktiv, nicht rekrutierend» Google-Maps
Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics)
60611 Chicago
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Sonali Chaudhury, MD
Phone: 312-227-4090
E-Mail: schaudhury@luriechildrens.org
» Ansprechpartner anzeigen
University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)
60637 Chicago
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Satayaijt Kosuri, MD
Phone: 773-702-7540
E-Mail: skosuri@medicine.bsd.uchicago.edu
» Ansprechpartner anzeigen
Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)
02215 Boston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Sarah Nikiforow, MD
Phone: 617-632-6640
E-Mail: sarah_nikiforow@dfci.harvard.edu
» Ansprechpartner anzeigen
Washington University School of Medicine (Adults only)
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Armin Ghobadi, MD
Phone: 314-747-8439
E-Mail: arminghobadi@wustl.edu
» Ansprechpartner anzeigen
Montefiore Medical Center (Adults only)
10467 Bronx
United StatesAbgeschlossen» Google-Maps
Montefiore Medical Center (Pediatrics only)
10467 Bronx
United StatesAbgeschlossen» Google-Maps
Columbia University Medical Center (Adults and Pediatrics)
10032 New York
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Ran Reshef, MD
Phone: 212-342-0530
E-Mail: rr3036@cumc.columbia.edu
» Ansprechpartner anzeigen
Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)
10065 New York
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Susan Prockop, MD
Phone: 212-639-6715
E-Mail: prockops@mskcc.org
» Ansprechpartner anzeigen
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)
27599 Chapel Hill
United StatesAbgeschlossen» Google-Maps
Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)
28204 Charlotte
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Michael Kent, MD
Phone: 704-381-9900
E-Mail: Michael.kent@atriumhealth.org
» Ansprechpartner anzeigen
Nationwide Children's Hospital (Pediatrics only)
43205 Columbus
United StatesAbgeschlossen» Google-Maps
The Ohio State University - Arthur G. James Cancer Center Hospital (Adults and Pediatrics)
43210 Columbus
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Robert Baiocchi, MD, PhD
Phone: 614-293-3196
E-Mail: robert.baiocchi@osumc.edu
» Ansprechpartner anzeigen
Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)
97239 Portland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Nemecek Eneida, MD
Phone: 503-494-5058
E-Mail: nemeceke@ohsu.edu
» Ansprechpartner anzeigen
Children's Hospital of Philadelphia (Pediatrics only)
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Nancy Bunin, MD
Phone: 215-590-2255
E-Mail: buninn@email.chop.edu
» Ansprechpartner anzeigen
University of Pennsylvania (Adults only)
19104 Philadelphia
United StatesAktiv, nicht rekrutierend» Google-Maps
Medical University of South Carolina (Adults and Pediatrics)
29425 Charleston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Michelle Hudspeth, MD
Phone: 843-792-0381
E-Mail: hudspeth@musc.edu
» Ansprechpartner anzeigen
Saint Jude Children's Research Hospital (Pediatrics only)
38105 Memphis
United StatesAbgeschlossen» Google-Maps
Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)
37232 Nashville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Gowri Satyanarayana, MD
Phone: 615-322-2035
E-Mail: gowri.satyanarayana@vanderbilt.edu
» Ansprechpartner anzeigen
Baylor Scott and White Research Institute (Adults only)
75246 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Luis Pineiro, MD
Phone: 214-370-1000
E-Mail: luis.pineiro@usoncology.com
» Ansprechpartner anzeigen
University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)
75390 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Tamra Slone, MD
Phone: 214-648-3150
E-Mail: tamra.slone@utsouthwestern.edu
» Ansprechpartner anzeigen
MD Anderson Cancer Center (Adults and Pediatrics)
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Kris Michael Mahadeo, MD
Phone: 713 792-2873
E-Mail: kmmahadeo@mdanderson.org
» Ansprechpartner anzeigen
Froedtert Hospital & the Medical College of Wisconsin (Adults only)
53226 Milwaukee
United StatesAbgeschlossen» Google-Maps
Westmead Hospital (Adults only)
2145 Westmead
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Shyam Panicker, MD, MBBS, MRCP, FRACP, FRCPA
Phone: +61 (2) 9845 6352
E-Mail: shyam.panicker@health.nsw.gov.au
» Ansprechpartner anzeigen
The Prince Charles Hospital (Adults only)
4032 Chermside
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Daniel Chambers, MBBS, MRCP, FRACP, MD
Phone: +61 (7) 3139 4000
E-Mail: daniel.chambers@health.qld.gov.au
» Ansprechpartner anzeigen
The Royal Children's Hospital Melbourne (Pediatrics only)
3052 Melbourne
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Rachel Conyers, MD, MBBS, FRACP
Phone: +61 (3) 9345 5658
E-Mail: rachel.conyers@rch.org.au
» Ansprechpartner anzeigen
Fiona Stanley Hospital (Adults only)
6150 Murdoch
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Duncan Purtill, MD, MBBS, FRACP, FRCPA
Phone: +61 (8) 6152 3788
E-Mail: duncan.purtill@health.wa.gov.au
» Ansprechpartner anzeigen
Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics)
4000 Liège
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Willems Evelyne, MD
Phone: +32 4 366 72 01
E-Mail: e.willems@chu.ulg.ac.be
» Ansprechpartner anzeigen
Universitair Ziekenhuis Leuven (Adults and Pediatrics)
3000 Leuven
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Daan Dierickx, MD
Phone: +32 16 34 68 80
E-Mail: daan.dierickx@uzleuven.be
» Ansprechpartner anzeigen
Alberta Children's Hospital (Adults and Pediatrics)
T3B 6A8 Calgary
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Victor Lewis, MD
Phone: 1 (403) 955-7203
E-Mail: victor.lewis@albertahealthservices.ca
» Ansprechpartner anzeigen
Groupe Hospitalier du Haut Leveque (Adults only)
33600 Pessac
FranceRekrutierend» Google-Maps
Ansprechpartner:
Edouard Forcade, MD
Phone: +33 557656511
E-Mail: edouard.forcade@chu-bordeaux.fr
» Ansprechpartner anzeigen
Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics)
59037 Lille cedex
FranceRekrutierend» Google-Maps
Ansprechpartner:
Franck Morschhauser, MD
Phone: +33 320445962
E-Mail: franck.morschhauser@chru-lille.fr
» Ansprechpartner anzeigen
Hôpital Universitaire Pitié Salpêtrière (Adults only)
75651 Paris Cedex 13
FranceRekrutierend» Google-Maps
Ansprechpartner:
Sylvain Choquet, MD
Phone: +33 142162826
E-Mail: sylvain.choquet@psl.aphp.fr
» Ansprechpartner anzeigen
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only)
20162 Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Roberto Cairoli, MD
Phone: +39 2 64441
E-Mail: roberto.cairoli@ospedaleniguarda.it
» Ansprechpartner anzeigen
Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics)
27100 Pavia
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Patrizia Comoli, MD
Phone: +39 0382 502716
E-Mail: pcomoli@smatteo.pv.it
» Ansprechpartner anzeigen
Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics)
39008 Santander
SpainRekrutierend» Google-Maps
Ansprechpartner:
Lucrecia Yanez, MD
Phone: +34 942202573
E-Mail: lucrecia.yanez@scsalud.es
» Ansprechpartner anzeigen
Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics)
08035 Barcelona
SpainRekrutierend» Google-Maps
Ansprechpartner:
Pere Barba, MD
Phone: +34 93 274 6100
Phone (ext.): 4897
E-Mail: pbarba@vhio.net
» Ansprechpartner anzeigen
Hospital General Universitario Gregorio Marañón (Adults and Pediatrics)
28009 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Gillen Oarbeascoa, MD
Phone: +34 91 586 84 43
E-Mail: gillen.oarbeascoa@salud.madrid.org
» Ansprechpartner anzeigen
University Hospital Virgen del Rocio (Adults and Pediatrics)
41013 Sevilla
SpainRekrutierend» Google-Maps
Ansprechpartner:
Jose Perez-Simon, MD
Phone: 34-955 013260
E-Mail: josea.perez.simon.sspa@juntadeandalucia.es
» Ansprechpartner anzeigen
Imperial College Healthcare NHS Trust (Adults only)
W12 0HS London
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
Eduardo Olavarria, MD
Phone: +44 0208 383 2134
E-Mail: e.olavarria@nhs.net
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a multicenter, open-label, phase 3 study to assess the efficacy and safety of

tabelecleucel for the treatment of EBV+ PTLD in the setting of SOT after failure of rituximab

and rituximab plus chemotherapy (SOT cohort) or HCT after failure of rituximab (HCT cohort).

Enrollment will be preceded by confirmation of availability of partially human leukocyte

antigen (HLA) matched and restricted tabelecleucel for the participant.

Study procedures and product administration will be the same for each cohort. Tabelecleucel

will be administered in cycles lasting 5 weeks (35 days). During each cycle, participants

will receive intravenous tabelecleucel at a dose of 2×10^6 cells/kg on Days 1, 8, and 15,

followed by observation through Day 35. Treatment will continue until maximal response,

unacceptable toxicity, initiation of non protocol therapy, or failure of tabelecleucel with

up to 2 different HLA restrictions (SOT cohort) or up to 4 different HLA restrictions (HCT

cohort). The study includes a total of 5 years of follow-up for disease and survival status.

This protocol has been amended to include the HCT cohort from clinical study ATA129-EBV-301

(NCT03392142).

NOTE, 29 April 2020: Enrollment is temporarily paused at study site/locations with status

"active, not recruiting" due to COVID-19 restrictions.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of

these (SOT cohort); or prior allogeneic HCT (HCT cohort)

2. A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD

3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has

been confirmed by the sponsor

4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using

Lugano Classification response criteria by positron emission tomography

(PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by

local practice, then magnetic resonance imaging (MRI) may be used.For subjects with

treated central nervous system (CNS) disease, a head CT and/or brain/spinal MRI as

clinically appropriate will be required to follow CNS disease response per Lugano

Classification response criteria.

5. Treatment failure of rituximab monotherapy (SOT cohort, subgroup A or HCT cohort) or

rituximab plus chemotherapy (SOT cohort, subgroup B) for treatment of PTLD.

6. Eastern Cooperative Oncology Group performance status ≤ 3 for subjects aged ≥ 16

years; Lansky score ≥ 20 for subjects < 16 years

7. For HCT cohort only: If allogeneic HCT was performed as treatment for an acute

lymphoid or myeloid malignancy, the underlying primary disease for which the subject

underwent transplant must be in morphologic remission

8. Adequate organ function

1. Absolute neutrophil count ≥ 1000/μL, (SOT cohort) or ≥ 500/μL (HCT cohort), with

or without cytokine support

2. Platelet count ≥ 50,000/μL, with or without transfusion or cytokine support. For

HCT cohort, platelet count < 50,000/μL but ≥ 20,000/μL, with or without

transfusion support, is permissible if the subject has not had grade ≥ 2 bleeding

in the prior 4 weeks (where grading of the bleeding is determined per the

National Cancer Institute's Common Terminology Criteria for Adverse Events

[CTCAE], version 5.0)

3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total

bilirubin each < 5 × the upper limit of normal; however, ALT, AST, and total

bilirubin each ≤ 10 × upper limit of normal is acceptable if the elevation is

considered by the investigator to be due to EBV and/or PTLD involvement of the

liver as long as there is no known evidence of significant liver dysfunction

9. Subject or subject's representative is willing and able to provide written informed

consent

Exclusion Criteria:

1. Burkitt lymphoma, classical Hodgkin lymphoma, or any T cell lymphoma

2. Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing

methotrexate, or extracorporeal photopheresis

3. Untreated CNS PTLD or CNS PTLD for which the subject is actively receiving

CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment.

NOTE:Subjects with previously treated CNS PTLD may enroll if CNS-directed therapy is

complete.

4. Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) per the Center for

International Blood and Marrow Transplant Research consensus grading system at

enrollment

5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab,

nivolumab) within 3 drug half-lives from the most recent dose to enrollment

6. For HCT cohort: active adenovirus viremia

7. Need for vasopressor or ventilatory support

8. Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to

enrollment

9. Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor

T cells directed against B cells within 8 weeks of enrollment (SOT or HCT cohorts), or

unselected donor lymphocyte infusion within 8 weeks of enrollment (HCT cohort only)

10. Female who is breastfeeding or pregnant or female of childbearing potential or male

with a female partner of childbearing potential unwilling to use a highly effective

method of contraception

11. Inability to comply with study-related procedures

Studien-Rationale

Primary outcome:

1. Objective response rate (ORR) in the SOT or HCT cohort (Time Frame - 2 years)



Secondary outcome:

1. Duration of response (DOR) in SOT and HCT cohorts separately (Time Frame - 2 years)

2. ORR and DOR in SOT and HCT cohorts combined (Time Frame - 2 years)

3. Rates of complete response (CR) and partial response (PR) (Time Frame - 2 years)

4. Time to response (Time Frame - 2 years)

5. Time to best response (Time Frame - 2 years)

6. Overall survival (OS) (Time Frame - 2 years)

7. Rates of allograft loss or rejection episodes (SOT cohort) (Time Frame - 2 years)

Studien-Arme

  • Experimental: SOT cohort -Subgroup A
    Participants who have failed rituximab will receive IV tabelecleucel.
  • Experimental: SOT cohort -Subgroup B
    Participants who have failed both rituximab and chemotherapy will receive IV tabelecleucel.
  • Experimental: HCT cohort
    Participants who have failed rituximab will receive IV tabelecleucel.

Geprüfte Regime

  • tabelecleucel (tab-cel® / ATA129 / EBV-CTL / ):
    Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

Quelle: ClinicalTrials.gov


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