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JOURNAL ONKOLOGIE – STUDIE

A Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

Rekrutierend

NCT-Nummer:
NCT04064060

Studienbeginn:
August 2019

Letztes Update:
01.12.2020

Wirkstoff:
Luspatercept

Indikation (Clinical Trials):
Myelodysplastic Syndromes, Primary Myelofibrosis, Thalassemia, Myeloproliferative Disorders, beta-Thalassemia, Preleukemia

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Celgene

Collaborator:
-

Studienleiter

Rodrigo Ito, M.D.
Study Director
Celgene Corporation

Kontakt

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

Studienlocations
(3 von 122)

Medizinisches Versorgungszentrum (MVZ) Onkologischer Schwerpunkt am Oskar-Helene-Heim
14195 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Carl Gustav Carus an der TU Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Duesseldorf
40225 Duesseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Brustkrebszentrum am Marien Hospital Düsseldorf
Rochusstraße 2
40479 Düsseldorf
DeutschlandRekrutierend» Google-Maps
Universitatsklinikum Halle Saale
06120 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
OncoResearch Lerchenfeld GmbH
22081 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
DeutschlandRekrutierend» Google-Maps
Universitatsklinikum Leipzig
04103 Leipzig
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Klinikum rechts der Isar der Technischen Universitaet Muenchen
81675 München
(Bayern)
GermanyRekrutierend» Google-Maps
Childrens Hospital Los Angeles RHU
90027-6062 Los Angeles
United StatesRekrutierend» Google-Maps
UCSF Benioff Children's Hospital Oakland
94609 Oakland
United StatesRekrutierend» Google-Maps
Stanford Cancer Center
94305 Stanford
United StatesRekrutierend» Google-Maps
Ann & Robert H Lurie Children's Hospital of Chicago
60611 Chicago
United StatesRekrutierend» Google-Maps
Boston Children's Hospital
02115 Boston
United StatesRekrutierend» Google-Maps
Karmanos Cancer Institute
48201 Detroit
United StatesRekrutierend» Google-Maps
Weill Cornell Medical College
10065 New York
United StatesRekrutierend» Google-Maps
Hospital of the University of Pennsylvania
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Vanderbilt - Ingram Cancer Center
37232-5505 Nashville
United StatesNoch nicht rekrutierend» Google-Maps
The University of Texas - MD Anderson Cancer Center
77030 Houston
United StatesNoch nicht rekrutierend» Google-Maps
Mater Hospital Brisbane
4101 South Brisbane
AustraliaRekrutierend» Google-Maps
Royal Prince Alfred Hospital
2050 Camperdown
AustraliaRekrutierend» Google-Maps
Prince of Wales Hospital
2031 Randwick
AustraliaNoch nicht rekrutierend» Google-Maps
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
4002 Plovdiv
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Specialized Hospital for Active Treatment of Haematological Diseases - Sofia
1756 Sofia
BulgariaRekrutierend» Google-Maps
Multiprofile Hospital for Active Treatment Sveta Marina EAD
9010 Varna
BulgariaNoch nicht rekrutierend» Google-Maps
Sunnybrook Health Sciences Centre
M4N 3M5 Toronto
CanadaRekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon
38700 La Tronche
FranceRekrutierend» Google-Maps
CHRU de Lille-Hopital Claude Huriez
59037 Lille
FranceRekrutierend» Google-Maps
Hopitaux de La Timone
13385 Marseille Cedex 9
FranceRekrutierend» Google-Maps
Hopital Haut Leveque
33604 Pessac Cedex
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Lyon Sud
69495 Pierre Benite cedex
FranceRekrutierend» Google-Maps
Institut Universitaire du Cancer de Toulouse - Oncopole
31059 Toulouse Cedex 9
FranceRekrutierend» Google-Maps
Aghia Sophia' Children's General Hospital of Athens
115 27 Athens
GreeceRekrutierend» Google-Maps
Laiko General Hospital of Athens - Center of Thalassemia
115 27 Athens
GreeceRekrutierend» Google-Maps
General Hospital Georgios Gennimatas of Athens
11527 Athens
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University General Hospital of Patras
26500 Rio Patras
GreeceRekrutierend» Google-Maps
General Hospital of Thessaloniki Hippokration
54642 Thessaloniki
GreeceRekrutierend» Google-Maps
Shaare Zedek Medical Center
91031 Jerusalem
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Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo
15100 Allessandria
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps
Presidio Ospedaliero Antonio Perrino
72100 Brindisi
ItalyRekrutierend» Google-Maps
Azienda Sanitaria Locale (ASL) Cagliari - Ospedale Regionale per le Microcitemie
09121 Cagliari
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
44124 Ferrara
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Careggi
50134 Firenze
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Careggi
50134 Firenze
ItalyNoch nicht rekrutierend» Google-Maps
Ente Ospedaliero Ospedali Galliera - Centro della Microcitemia e delle Anemie Congenite
16128 Genoa
ItalyRekrutierend» Google-Maps
Maggiore Polyclinic Hospital, IRCCS Ca' Granda
20122 Milano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Di Modena Policlinico
41100 Modena
ItalyRekrutierend» Google-Maps
AOU dell'Università degli Studi della Campania Luigi Vanvitelli
80131 Napoli
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Azienda Ospedaliero Universitaria S. Luigi Gonzaga
10043 Orbassano
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Azienda Ospedaliera Bianchi Melacrino Morelli
89124 Reggio Di Calabria
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Fondazione PTV Policlinico Tor Vergata
133 Roma
ItalyRekrutierend» Google-Maps
Istituto Clinico Humanitas
20089 Rozzano
ItalyNoch nicht rekrutierend» Google-Maps
Ospedale di Circolo di Varese
21100 Varese
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Integrata Di Verona
37134 Verona
ItalyRekrutierend» Google-Maps
Hospital Sultanah Aminah
80100 Johor Bahru
MalaysiaRekrutierend» Google-Maps
Hospital Sultanah Bahiyah
05460 Alor Setar
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Hospital Raja Permaisuri Bainun
30990 Ipoh
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Queen Elizabeth Hospital
88586 Kota Kinabalu
MalaysiaRekrutierend» Google-Maps
University Malaya Medical Centre
59100 Kuala Lumpur
MalaysiaRekrutierend» Google-Maps
Vrije Universiteit Medisch Centrum (VUMC)
1081 HV Amsterdam
NetherlandsRekrutierend» Google-Maps
Hospital Universitario Cruces
48903 Barakaldo
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
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Instituto Catalan de Oncologia-Hospital Duran i Reynals
08908 Barcelona
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon
28007 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Central de Asturias
33011 Oviedo
SpainRekrutierend» Google-Maps
Universitario de Salamanca - Hospital Clinico
37007 Salamanca
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
41013 Seville
SpainRekrutierend» Google-Maps
Hospital Universitari i Politecnic La Fe de Valencia
46026 Valencia
SpainRekrutierend» Google-Maps
Sahlgrenska Universitetssjukhuset
413 45 Goteborg
SwedenRekrutierend» Google-Maps
Skanes Universitetssjukhus Lund
SE-221 85 Lund
SwedenRekrutierend» Google-Maps
Karolinska Universitetssjukhuset - Huddinge
141 86 Stockholm
SwedenRekrutierend» Google-Maps
Kaohsiung Medical University Hospital
807 Kaohsiung, San Ming Dist.
TaiwanRekrutierend» Google-Maps
China Medical University Hospital
40447 Taichung
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National Taiwan University Hospital
10002 Taipei, Zhongzheng Dist.
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Chulalongkorn University Faculty of Medicine - King Chulalongkorn Memorial Hospital
10330 Bangkok
ThailandRekrutierend» Google-Maps
Siriraj Hospital Mahidol University
10700 Bangkok
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Chiang Mai University - Maharaj Nakorn Chiang Mai Hospital
50200 Chiang Mai
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University Hospital Farhat Hached
4031 Sousse
TunisiaRekrutierend» Google-Maps
Ankara University Medical Faculty Cebeci Hospital
06590 Ankara
TurkeyRekrutierend» Google-Maps
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
34093 Istanbul
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Istanbul University Cerrahpasa Medical Faculty Hospital
34098 Istanbul
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Ege Universitesi Tip Fakultesi Hastanesi
35100 Izmir
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Mersin University Medical Faculty
33343 Mersin
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Aberdeen Royal Infirmary
AB25 2ZN Aberdeen
United KingdomRekrutierend» Google-Maps
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
LS9 7TF Leeds
United KingdomNoch nicht rekrutierend» Google-Maps
Barts Health NHS Trust - The Royal London Hospital
E1 1BB London
United KingdomRekrutierend» Google-Maps
Whittington Hospital
N19 5NF London
United KingdomRekrutierend» Google-Maps
University College London Hospitals NHS Foundation Trust - University College Hospital
NW1 2BU London
United KingdomRekrutierend» Google-Maps
Kings College Hospital
SE5 9RS London
United KingdomRekrutierend» Google-Maps
Oxford University Hospitals NHS Foundation Trust-Churchill Hospital-Cancer and Haematology Centre
OX3 7LE Oxford
United KingdomNoch nicht rekrutierend» Google-Maps
Kings Mill Hospital
NG17 4JL Sutton in Ashfield
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of

luspatercept, to the following subjects:

- Subjects receiving luspatercept on a parent protocol at the time of their transition to

the rollover study, who tolerate the protocol-prescribed regimen in the parent trial

and, in the opinion of the investigator, may derive clinical benefit in the opinion of

the investigator from continuing treatment with luspatercept.

- Placebo arm subjects from parent protocol (at the time of unblinding or in follow-up)

crossing over to luspatercept treatment (provided subjects have met all requirements for

entering the rollover study as per the parent protocol).

- Subjects in the follow-up phase previously treated with luspatercept or placebo in the

parent protocol will continue into long-term post-treatment follow-up in the rollover

study until the follow-up commitments are met (unless they meet requirements as per

parent protocol to cross-over to luspatercept treatment).

The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase.

Subjects will enter transition phase and depending on their background will enter either the

treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase.

- Transition Phase (Screening): up to 21 days prior to enrollment

- Treatment Phase: For subjects in luspatercept treatment the dose and schedule of

luspatercept in this study will be the same as the last dose and schedule in the parent

luspatercept study. For placebo arm subjects from parent protocol (at the time of

unblinding or in follow-up) crossing over to luspatercept treatment (provided subjects

have met all requirements for entering the rollover study as per the parent protocol)

will start at a luspatercept dose of 1.0 mg/kg every 3 weeks (Q3W). This does not apply

to subjects that are in long-term follow-up from the parent protocol.

- Follow-up Phase:

- 42 Day Safety Follow-up Phase: subjects will be followed for 42 days after the last

dose of luspatercept, for the assessment of safety-related parameters and adverse

event (AE) reporting.

- Long-term Post-treatment Follow-up (LTPTFU) Phase:

All subjects who are continuing in the LTPTFU Phase, will continue to be followed for 5 years

from Dose 1 of the parent protocol, or 3 years of post-treatment from last dose of the parent

protocol, whichever occurs later. Subjects will be followed every 6 months until death,

withdrawal of consent, study termination, or until a subject is lost to follow-up. Subjects

will also be monitored for progression to AML or any malignancies/pre- malignancies. New

anticancer or disease related therapies should be collected at the same time schedule.

Subjects transitioning from a parent luspatercept study in post-treatment follow-up (safety

or LTPTFU) will continue from the same equivalent point in this rollover study.

The rollover study will be terminated, and relevant subjects will discontinue from the study

when all subjects fulfill 5 years from Dose 1 of the parent protocol, or 3 years of

post-treatment from last dose of the parent protocol, whichever occurs later. The shift to

commercial drug is an alternative way to stop the study.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Subjects must meet all the following criteria to be enrolled in this study:

1. Subject is ≥ 18 years at the time of signing the informed consent form (ICF).

2. Subject is willing and able to adhere to the study visit schedule and other protocol

requirements.

3. Subject has been participating in a luspatercept trial and continues to fulfill all

the requirements of the parent protocol and the subject has been either:

1. Assigned to luspatercept treatment, continues to receive clinical benefit in the

opinion of the investigator and should continue to receive luspatercept

treatment, OR

2. Assigned to placebo arm in the parent protocol (at the time of unblinding or in

follow-up) and should cross over to luspatercept treatment, OR

3. Assigned to the Follow-up Phase of the parent protocol, previously treated with

luspatercept or placebo in the parent protocol who shall continue into Long-term

Post-treatment Follow-up Phase in the rollover study until the follow-up

commitments are met (unless requirements are met as per parent protocol to

crossover to luspatercept treatment).

4. Subject understands and voluntarily signs an informed consent document prior to any

study-related assessments or procedures being conducted.

5. Subject demonstrates compliance, as assessed by the investigator, with the parent

study protocol requirements.

6. Applies to on treatment subjects only- females of childbearing potential (FCBP)

defined as a sexually mature woman who:

1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral

oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer

therapy does not rule out childbearing potential) for at least 24 consecutive months (ie,

has had menses at any time in the preceding 24 consecutive months) and must:

1. Have two negative pregnancy tests as verified by the investigator prior to starting

study therapy. She must agree to ongoing pregnancy testing during the course of the

study, and after end of study therapy. This applies even if the subject practices true

abstinence* from heterosexual contact.

2. Either commit to true abstinence* from heterosexual contact (which must be reviewed on

a monthly basis and source documented) or agree to use, and be able to comply with

highly effective, contraception without interruption, 35 days prior to starting

investigational product (IP), during the study therapy (including dose interruptions),

and for 84 days after discontinuation of study therapy.

7. Applies to on treatment subjects only- Male subjects must:

a. Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a

condom during sexual contact with a pregnant female or a female of childbearing potential

while participating in the study, during dose interruptions and for at least 84 days

following investigational product discontinuation even if he has undergone a successful

vasectomy.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Applies to on treatment subjects only- Concomitant use of any medications/procedures

that are prohibited in the parent luspatercept protocol.

2. Subject has met one or more criteria for study discontinuation as stipulated in the

parent luspatercept protocol.

3. First luspatercept transition visit into rollover study > 21 days after end of study

(EOS) visit (last dose/visit in case of no EOS visit) of the parent luspatercept study

with the exception of those subjects already in the Post-treatment Follow up Phase

from the parent study. Note-Subject with current dose delays from the parent protocol

during the Transition Phase, will continue in the rollover protocol regardless of the

delay.

4. Applies to on treatment subjects only- Pregnant or breastfeeding females.

5. Subject has any significant medical condition, laboratory abnormality, psychiatric

illness, or is considered vulnerable by local regulations (eg, imprisoned or

institutionalized) that would prevent the subject from participating in the study.

6. Subject has any condition including the presence of laboratory abnormalities, which

places the subject at unacceptable risk if he/she were to participate in the study.

7. Subject has any condition that confounds the ability to interpret data from the study.

Studien-Rationale

Primary outcome:

1. Adverse Events (AEs) (Time Frame - From enrollment until at least 42 Day Safety Follow-up Phase or EOS (Approximately 5 years).):
Type, frequency, severity of AEs, relationship of treatment emergent adverse events to luspatercept

2. Number of subjects progressing to high/very high risk MDS or AML. (Time Frame - Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)):
Progression to high/very high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) (MDS and myelofibrosis [MF] only).

3. Percentage of subjects progressing to high/very high risk MDS or AML (Time Frame - Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)):
Progression to high/very high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) (MDS and myelofibrosis [MF] only)

4. Number of subjects developing other malignancies/pre-malignancies (Time Frame - Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)):
Development of other malignancies/pre-malignancies

5. Percentage of subjects developing other malignancies/pre-malignancies (Time Frame - Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)):
Development of other malignancies/pre-malignancies

Secondary outcome:

1. Overall Survival (Time Frame - Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)):
Time from date of randomization until death from any cause

Geprüfte Regime

  • Luspatercept (ACE-536):
    Luspatercept (ACE-536), an erythroid maturation agent, is a recombinant fusion protein consisting of a modified form of the extracellular domain (ECD) of the human activin receptor type IIB (ActRIIB) linked to the human immunoglobin G 1 (IgG1) Fc domain. ActRIIB receptor and its ligands are members of the transforming growth factor-β (TGF-β) superfamily. Members of the TGF-β superfamily ligands, through their binding to activin receptors, are involved in modulating the differentiation of late-stage erythrocyte precursors (normoblasts) in the bone marrow. Luspatercept for injection is formulated as a sterile, preservative-free, lyophilized cake/powder. Luspatercept for injection is available in 25 mg and 75 mg vials and when reconstituted with water for injection, each consists of 50 mg/mL luspatercept in a 10 mM citrate buffer-based solution

Quelle: ClinicalTrials.gov


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