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JOURNAL ONKOLOGIE – STUDIE

Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Rekrutierend

NCT-Nummer:
NCT02227251

Studienbeginn:
November 2014

Letztes Update:
29.03.2024

Wirkstoff:
Selinexor

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Karyopharm Therapeutics Inc

Collaborator:
-

Kontakt

Studienlocations
(3 von 176)

Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Aachen
(Nordrhein-Westfalen)
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Brustzentrum im HELIOS Klinikum Bad Saarow
Pieskower Straße 33
15526 Bad Saarow
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Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)
Berlin
(Berlin)
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Charite Universitatsmedizin Berlin (Virchow Campus)
Berlin
(Berlin)
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Ev. Diakonie-Krankenhaus gGmbH
28239 Bremen
(Bremen)
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Gemeinschaftspraxis Haematologie and Onkologie-Dresden
01307 Dresden
(Sachsen)
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Martin-Luther-University Halle-Wittenberg Department of Oncology
Halle
(Sachsen-Anhalt)
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Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
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Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie
Heidelberg
(Baden-Württemberg)
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Klinikum Kempten Klinik für Innere Medizin III - Hämatologie, Onkologie und Palliativmedizin
Koln
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Klinikum Leverkusen
Leverkusen
(Nordrhein-Westfalen)
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Klinikum Ludwigshafen
Ludwigshafen
(Rheinland-Pfalz)
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Interdisziplinäres Brustkrebszentrum am Rotkreuzklinikum München
Taxisstraße 3
80637 München
(Bayern)
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Klinikum Nürnberg Nord
90419 Nuernberg
(Bayern)
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University of California San Francisco
San Francisco
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University of California Los Angeles (UCLA)
90404 Santa Monica
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Boca Raton Cancer Research Medical Center
Plantation
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University of Chicago
60637 Chicago
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Robert H. Lurie Comprehensive Cancer Center/Northwestern University
Chicago
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Norton Cancer Institute
40241 Louisville
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Dana Farber Cancer Institute
Boston
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University of Massachusetts Medical School
Worcester
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John Theurer Cancer Center at Hackensack University Medical Center
Hackensack
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Clinical Research Alliance
Lake Success
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New York Presbyterian Hospital/ Cornell Medical College
10065 New York
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Stony Brook University Hospital
11794 Stony Brook
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Cleveland Clinic Foundation
44195 Cleveland
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University Hospitals Seidman Cancer Center
Cleveland
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University of Oklahoma
Oklahoma City
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Greenville Hospital System
29605 Greenville
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Swedish Cancer Institute
98104 Seattle
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Virginia Mason Hospital & Medical Center
Seattle
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St. Vincent's Hospital Sydney
2010 Darlinghurst
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Liverpool Hospital, Ingham Institute of Medical Research
2170 Liverpool
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Calvary Mater Newcastle Hospital
2298 Waratah
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Ashford Cancer Centre
5037 Kurralta Park
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Medizinische Universität Innsbruck für Innere Medizin
Innsbruck
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LKH Leoben Department for Haemato-Oncology
8700 Leoben
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Linz
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A-5020 Salzburg
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Medical University of Vienna (MUW) Department of Medicine I
Vienna
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H-Hartziekenhuis Roeselare-Menen
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5800 Pleven
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1431 Sofia
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1756 Sofia
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Montreal
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Centre Hospitalier Universitaire Henri Mondor
Créteil
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Unite Hemopathies Lymphoides Chu Henri Mondor
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La Rochelle
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CHRU de Lille - Hopital Claude-Huriez
Lille
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Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille
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Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie)
75010 Paris
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Hôpital Necker Service d'Hématologie Adult
Paris
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National & Kapodistrian University of Athens, Laiko General Hospital
11527 Athens
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Second Depth of Internal Medicine, Attiko University Hospital
Athens
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Ansprechpartner:
Panagiotis Tsirigotis
Phone: +306944618814
E-Mail: panagtsirigotis@gmail.com» Ansprechpartner anzeigen
National & Kapodistrian University of Athens, Attiko University Hospital
12462 Chaidari
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Department of clinical hematology ,university hospital Ioannina
45110 Ioánnina
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Ansprechpartner:
Eleni Kapsali
Phone: 0032651099650
E-Mail: elkapsali@gmail.com» Ansprechpartner anzeigen
University of Patras Medical School
26504 Patras
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Semmelweis Egyetem Általános Orvosi Kar
1083 Budapest
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Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály
1122 Budapest
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Semmelweis University Department of Medicine and Oncology
Budapest
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Somogy Megyei Kaposi Mór Oktató Kórház
7400 Kaposvár
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Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika
Pécs
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Veszprém Megyei Csolnoky Ferenc Kórház
8200 Veszprém
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SRM Institutes for Medical Science
600026 Vadapalani
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Rajiv Gandhi Cancer Hospital
110085 New Delhi
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Regional Cancer Centre
695011 Thiruvananthapuram
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Jaslok Hospital and Research Centre
400026 Mumbai
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Institute of Medical Sciences & SUM Hospital
751003 Bhubaneswar
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Dayanand Medical College and Hospital
160012 Ludhiāna
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Saveetha Medical College Hospital
602105 Chennai
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G. Kuppu Swamy Naidu Hospital
641037 Coimbatore
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Meenakshi Mission Hospital & Research Centre
625107 Madurai
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King George's Medical University (KGMU)
226003 Lucknow
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Nil Ratan Sircar Medical College and Hospital
700014 Kolkata
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Netaji Subhas Chandra Bose Cancer Research Hospital
700094 Kolkata
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Netaji Subhas Chandra Bose Cancer Research Institute
70016 Kolkata
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IRCH, All India Institute of Medical Sciences
110029 Delhi
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Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences
110029 New Delhi
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Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna
Bologna
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Hematology-Oncology & Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS
80131 Naples
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Antonio Pinto
Phone: +39 (0) 81 5903 1816
E-Mail: a.pinto@istitutotumori.na.it» Ansprechpartner anzeigen
SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale
28100 Novara
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Città della Salute e della Scienza di Torino
Torino
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VUMc (Vrije Universiteit Amsterdam)
1081 HV Amsterdam
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LUMC (leidse universitair medisch centrum)
Leiden
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Christchurch Hospital
8001 Christchurch
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Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii
81-519 Gdynia
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MCM (Małopolskie Centrum Medyczne)
30-510 Krakow
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Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
20-081 Lublin
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Hematology Department St John's Cancer Centre
Lublin
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Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa
10-228 Olsztyn
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Instytut Hematologii i Transfuzjologii
02-776 Warszawa
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Centrum Onkologii- Insytut Im. Marii Skłodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego
02-781 Warszawa
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Maria Sklodowska Curie National Research Institute
Warszawa
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Ansprechpartner:
Joanna Romejko-Jarosinska
Phone: 48225462448
E-Mail: joanna.romejko-jarosinska@pib-nio.pl» Ansprechpartner anzeigen
Memorial Provincial Specialist Hospital in Lodz
62-1010 Łódź
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Institut za onkologiju i radiologiju Srbije
11000 Belgrade
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Klinicko Bolnick Centar Zemun Odeljenje hematologije
11000 Belgrade
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Klinički centar Srbije Klinika za hematologiju
11000 Belgrade
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Kliničko bolnički centar Zvezdara
11000 Belgrade
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Klinički centar Niš Klinika za hematologiju
18000 Nis
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Institut za onkologiju Vojvodine
21204 Sremska Kamenica
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Hospitla Universitari Germans Trias i Pujol - ICO
8916 Badalona
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Hospital University Vall d'Hebron
08035 Barcelona
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37007 Salamanca
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Hospital Universitario Virgen del Rocio
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Gloucestershire Royal Hospital
GL1 3NN Gloucester
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Southampton University Hospital
SO16 6YD Southampton
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Royal Marsden Hospital
SM2 5PT Sutton
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Northwick Park Hospital
HA1 3UJ Harrow
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Leeds Teaching Hospitals NHS Trust
Leeds
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Addenbrooke's Hospital Cambridge
CB2 0QQ Cambridge
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Royal Liverpool University Hospital
Liverpool
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The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool
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King's College Hospital
SE5 9RS London
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Princess Royal University Hospital (PRUH)
SE5 9RS London
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Guy's and St Thomas' NHS Foundation Trust
London
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The Christie NHS Foundation Trust
M20 4BX Manchester
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Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital
OX3 7LE Oxford
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Derriford Hospital
PL6 8DH Plymouth
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Alle anzeigen

Studien-Informationen

Detailed Description:

This is a multicenter, open label, Phase 2b study of the selective inhibitor of nuclear

export (SINE) selinexor (40 or 60 milligrams [mg]) given orally (PO) to participants with R/R

DLBCL). The study is being conducted in 2 parts (Part 1 and Part 2). For Part 1, a fixed 60

mg dose of selinexor is given orally to 130 participants with R/R DLBCL who have no

therapeutic options of demonstrated clinical benefit and who meet eligibility criteria and

have none of the exclusion criteria will be enrolled to receive selinexor until either

disease progression or intolerance has occurred. For Part 2, approximately 110 participants

(55 in each arm) are planned to be enrolled. Participants will be randomized (open label) in

a 1:1 ratio to either Arm A (40 mg) or Arm B (60 mg) and will be stratified based on history

of prior autologous stem cell transplantation (ASCT) versus no prior ASCT. All the

participants will be followed until disease progression and/or death.

Ein-/Ausschlusskriterien

Inclusion Criteria (Parts 1 and 2):

- Written informed consent in accordance with federal, local, and institutional

guidelines. The participant must provide informed consent prior to the first screening

procedure.

- Age greater than or equal to (≥) 18 years.

- ECOG performance status of less than or equal to (≤) 2.

- Participants should have estimated life expectancy of greater than (>) 3 months at

study entry.

- Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from

previously diagnosed indolent lymphoma (e.g., follicular lymphoma).

- Participants must have received at least 2 but no more than 5 previous systemic

regimens for the treatment of their de novo or transformed DLBCL including (i) at

least 1 course of anthracycline-based chemotherapy (unless absolutely contraindicated

due to cardiac dysfunction, in which case other active agents such as etoposide,

bendamustine, or gemcitabine must have been given) and (ii) at least 1 course of

anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe

toxicity. Participants who were considered ineligible for standard multi-agent

immunochemotherapy must have received at least 2 and no more than 5 prior treatment

regimens including at least 1 course of anti-CD20 antibodies and must be approved by

the Medical Monitor. Prior stem cell transplantation is allowed; induction,

consolidation, stem cell collection, preparative regimen and transplantation ±

maintenance are considered a single line of therapy.

- Female participants of child-bearing potential must have a negative serum pregnancy

test at screening and agree to use reliable methods of contraception for 3 months

after their last dose of medication. Male participants must use a reliable method of

contraception if sexually active with a female of child-bearing potential. For both

male and female participants, effective methods of contraception must be used

throughout the study and for 3 months following the last dose.

Part 1 additional inclusion criteria:

- For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR, at

least 60 days must have elapsed since the end of that therapy. For all other

participants, at least 14 weeks (98 days) must have elapsed since the end of their

most recent systemic anti-DLBCL therapy. . Palliative localized radiation within the

therapy-free interval is allowed. Non-chemotherapy maintenance will not be considered

anti DLBCL therapy, and therefore is allowed during the therapy-free interval.

- Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.

- Participants must have measurable disease per the revised criteria for response

assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is

>1.5 centimeter (cm), regardless of the short axis. If a lymph node has a long axis of

1.1 to 1.5 cm, it should only be considered abnormal if its short axis is >1.0. Lymph

nodes ≤1.0 by ≤1.0 will not be considered abnormal for relapse or PD.

Part 2 additional inclusion criteria:

• At least 3 weeks (21 days) must have elapsed since the end of participant's most recent

systemic anti-DLBCL therapy (prior to Cycle 1 Day 1). Palliative localized radiation within

the therapy-free interval is allowed.Non-chemotherapy maintenance will not be considered

anti-DLBCL therapy, and therefore is allowed during the therapy-free interval.

• Adequate hematopoietic function: (i) Hemoglobin ≥10.0 grams per deciliters (g/dL) within

14 days of starting therapy (participant may receive red blood cell [RBC] transfusion

within 14 days).

(ii) Absolute neutrophil count ≥1000 cells/millimeter (mm^3) (use of granulocyte growth

factors prior to and during the study is acceptable).

(iii) Platelet count ≥100,000/mm^3 within 14 days of starting therapy (use of platelet

growth factors prior to and during the study is acceptable).

- Participants must have measurable disease per the revised criteria for response

assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is

>1.5 cm, regardless of the short axis. Extranodal lesion should be considered abnormal

if the long axis is >1.0 cm.

Exclusion Criteria (Parts 1 and 2):

- Participants who are pregnant or lactating.

- Primary mediastinal (thymic) large B-cell lymphoma (PMBL)

- Participants must not be eligible for high-dose chemotherapy with autologous stem cell

transplantation rescue (Investigator must provide detailed documentation for

ineligibility).

- Participants who have not recovered to Grade ≤1 clinically significant adverse events,

or to their baseline, from their most recent systemic anti-DLBCL therapy.

- Major surgery within 2 weeks of first dose of study treatment.

- Participants with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human

immunodeficiency virus (HIV) infections.

- Psychiatric illness or substance use that would prevent the participant from giving

informed consent or being compliant with the study procedures.

- Any of the following laboratory abnormalities:

(i) A circulating lymphocyte count of >50,000/L. (ii) Hepatic dysfunction: bilirubin

>2.0 times the upper limit of normal (ULN) (except participants with Gilbert's

syndrome: total bilirubin of >3*ULN) and alanine aminotransferase (ALT) and aspartate

aminotransferase (AST) >2.5 times ULN. In participants with known liver involvement of

their DLBCL, AST and ALT >5*ULN.

(iii) Severe renal dysfunction: estimated creatinine clearance of <30 mL/min, measured in

24-hour urine or calculated using the formula of Cockroft and Gault [(140-Age)*Mass

(kg)/(72*creatinine mg/dL); multiply by 0.85 if female].

- Any life-threatening illness, medical condition, or organ system dysfunction which, in

the Investigator's opinion, could compromise the participant's safety.

- Participants with active graft-versus-host disease after allogeneic stem cell

transplantation. At least 4 months must have elapsed since completion of allogeneic

stem cell transplantation.

- Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics,

antivirals, or antifungals on Cycle 1 Day 1; however, prophylactic use of these agents

is acceptable even if parenteral.

- Participants unable to swallow tablets, participants with malabsorption syndrome, or

any other gastrointestinal disease or gastrointestinal dysfunction that could

interfere with absorption of study treatment.

Part 1 additional exclusion criteria:

- For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR:

Radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer

therapy other than glucocorticoids <60 days or <14 weeks prior to Cycle 1 Day 1.

- Known central nervous system lymphoma or meningeal involvement.

- DLBCL with mucosa-associated lymphoid tissue [MALT] lymphoma, composite lymphoma

(Hodgkin's lymphoma+NHL), or DLBCL transformed from diseases other than indolent NHL.

- Unstable cardiovascular function:

(i) Symptomatic ischemia, or (ii) Uncontrolled clinically significant conduction

abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st

degree atrioventricular block or asymptomatic left anterior fascicular block /right

bundle branch block will not be excluded), or (iii) Congestive heart failure of New

York Heart Association Class ≥3, or (iv) Myocardial infarction within 3 months.

- Participants with a BSA <1.4 m^2 as calculated per Dubois 1916 or Mosteller 1987.

- Any of the following laboratory abnormalities:

(i) Absolute neutrophil count (ANC) <1000 cells/mm^3 or platelet count <75,000/mm^3

during screening and on Cycle 1 Day 1. Use of granulocyte-stimulating factors and

platelet growth factors prior to and during the study is acceptable.

(ii) Hematopoietic dysfunction: hemoglobin < 10.0 g/dL within 14 days of and including

Cycle 1 Day 1 and/or patients receiving red blood cell (RBC) transfusion within 14 days of

and including Cycle 1 Day 1.

- Participants who have been committed to an institution by official or judicial order.

- Participants with dependency on the Sponsor, Investigator or study site.

Part 2 additional exclusion criteria:

- Participants with active HBV, HVC, or HIV infections. Participants with active HBV are

allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral

load is <100 International units per milliliters (IU/mL) prior to first dose of study

treatment. Participants with known history of HCV or found to be HCV antibody positive

on screening, are allowed if there is documentation of negative viral load per

institutional standard. Participants with HIV who have CD4+T-cell counts ≥350

cells/microliter (mcL), negative viral load per institutional standard, and no history

of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the

last year are allowed.

- Known active central nervous system lymphoma or meningeal involvement. Participants

with a history of CNS disease treated into remission may be enrolled.

- DLBCL with MALT lymphoma, composite lymphoma (Hodgkin's lymphoma + NHL), DLBCL arising

from CLL (Richter's transformation), or high-grade B-cell lymphoma.

- Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to Day 1 dosing or

strong CYP3A inducers ≤14 days prior to Day 1 dosing.

Studien-Rationale

Primary outcome:

1. Part 1: Overall Response Rate (ORR) (Time Frame - One year):
Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG).

2. Part 2: Overall Response Rate (ORR) Based on Lugano Criteria (Time Frame - From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)):
Assessed according to the response assessment of lymphoma based on Lugano classification.

Secondary outcome:

1. Part 1: Duration of Response (DOR) (Time Frame - From time of first response until disease progression or death (maximum of 1 year from Part 1 randomization))

2. Part 1: Disease Control Rate (DCR) (Time Frame - From initial response until disease progression or death (maximum of 1 year from Part 1 randomization))

3. Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Time Frame - From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization))

4. Part 1: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status (Time Frame - From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization))

5. Part 2: Duration of response (DOR) (Time Frame - From time of first response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization))

6. Part 2: Disease control rate (DCR) (Time Frame - From initial response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization))

7. Part 2: Overall Response Rate (ORR) Based on Modified Lugano Criteria (Time Frame - From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization))

8. Part 2: Number of Participants with Treatment-emergent Adverse Events (Time Frame - From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization))

9. Part 2: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status (Time Frame - From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization))

Studien-Arme

  • Experimental: Part 1: Selinexor 60 mg
    Participants received fixed dose of 60 mg selinexor orally, twice weekly (BIW) on Days 1 and 3 (e.g., Monday and Wednesday or Tuesday and Thursday, etc.) of Weeks 1-4 of each four week (each cycle of 28 days) cycle (total of 8 doses per cycle).
  • Experimental: Part 2: Arm A-Selinexor 40 mg
    Participants received selinexor 40 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles (28 days) until disease progression (total of 8 doses per cycle).
  • Experimental: Part 2: Arm B-Selinexor 60 mg
    Participants received selinexor 60 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles) for 2 cycles (each cycle of 28 days) followed by 60 mg once weekly (QW) in the subsequent cycles until disease progression (total of 8 doses per cycle).

Geprüfte Regime

  • Selinexor (KPT-330):
    Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
  • Selinexor (KPT-330):
    Dose: 40 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
  • Selinexor (KPT-330):
    Dose: 60 mg (BIW) and 60 mg (QW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)"

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