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
Study Director
Celgene Corporation
Kontakt
Kontakt:
Phone: 1-888-260-1599
E-Mail: clinicaltrialdisclosure@celgene.com» Kontaktdaten anzeigen
Studienlocations
(3 von 122)
14195 Berlin
(Berlin)
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01307 Dresden
(Sachsen)
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40225 Duesseldorf
(Nordrhein-Westfalen)
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Rochusstraße 2
40479 Düsseldorf
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06120 Halle
(Sachsen-Anhalt)
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22081 Hamburg
(Hamburg)
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Carl-Neuberg-Straße 1
30625 Hannover
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04103 Leipzig
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
55131 Mainz
(Rheinland-Pfalz)
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81675 München
(Bayern)
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90027-6062 Los Angeles
United StatesRekrutierend» Google-Maps
94609 Oakland
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94305 Stanford
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33612 Tampa
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60611 Chicago
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02115 Boston
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48201 Detroit
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10065 New York
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44195 Cleveland
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19104 Philadelphia
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37232-5505 Nashville
United StatesNoch nicht rekrutierend» Google-Maps
77030 Houston
United StatesNoch nicht rekrutierend» Google-Maps
4101 South Brisbane
AustraliaRekrutierend» Google-Maps
5000 Adelaide
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3168 Clayton
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2050 Camperdown
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2031 Randwick
AustraliaNoch nicht rekrutierend» Google-Maps
2930 Brasschaat
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8000 Brugge
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9000 Ghent
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3000 Leuven
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4002 Plovdiv
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1756 Sofia
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9010 Varna
BulgariaNoch nicht rekrutierend» Google-Maps
M4N 3M5 Toronto
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M5G 2C4 Toronto
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M5G 2M9 Toronto
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49033 Angers
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94010 Creteil
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38700 La Tronche
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59037 Lille
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13385 Marseille Cedex 9
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75010 Paris
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33604 Pessac Cedex
FranceNoch nicht rekrutierend» Google-Maps
69495 Pierre Benite cedex
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67091 Strasbourg
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31059 Toulouse Cedex 9
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37044 Tours
FranceNoch nicht rekrutierend» Google-Maps
115 27 Athens
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115 27 Athens
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11527 Athens
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26500 Rio Patras
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54642 Thessaloniki
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18341 Afula
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3109601 Haifa
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91031 Jerusalem
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91120 Jerusalem
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22100 Nahariya
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49100 Petah Tikva
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15100 Allessandria
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40138 Bologna
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72100 Brindisi
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09121 Cagliari
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44124 Ferrara
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50134 Firenze
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50134 Firenze
ItalyNoch nicht rekrutierend» Google-Maps
16128 Genoa
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73100 Lecce
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20122 Milano
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41100 Modena
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80131 Napoli
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80131 Napoli
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10043 Orbassano
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27100 Pavia
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89124 Reggio Di Calabria
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133 Roma
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20089 Rozzano
ItalyNoch nicht rekrutierend» Google-Maps
21100 Varese
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37134 Verona
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1003 Hazmieh
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80100 Johor Bahru
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05460 Alor Setar
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30990 Ipoh
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88586 Kota Kinabalu
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93586 Kuching
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59100 Kuala Lumpur
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1081 HV Amsterdam
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48903 Barakaldo
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08035 Barcelona
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08908 Barcelona
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28007 Madrid
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33011 Oviedo
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37007 Salamanca
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41013 Seville
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46026 Valencia
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413 45 Goteborg
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SE-221 85 Lund
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141 86 Stockholm
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807 Kaohsiung, San Ming Dist.
TaiwanRekrutierend» Google-Maps
40447 Taichung
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10002 Taipei, Zhongzheng Dist.
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10330 Bangkok
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10700 Bangkok
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50200 Chiang Mai
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4031 Sousse
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1006 Tunis
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1008 Tunis
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1008 Tunis
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01130 Adana
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06590 Ankara
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34093 Istanbul
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34098 Istanbul
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35100 Izmir
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33343 Mersin
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AB25 2ZN Aberdeen
United KingdomRekrutierend» Google-Maps
LS9 7TF Leeds
United KingdomNoch nicht rekrutierend» Google-Maps
E1 1BB London
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N19 5NF London
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NW1 2BU London
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SE5 9RS London
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OX3 7LE Oxford
United KingdomNoch nicht rekrutierend» Google-Maps
NG17 4JL Sutton in Ashfield
United KingdomNoch nicht rekrutierend» Google-Maps
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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