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An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

  • Clinicaltrials.gov identifier

    NCT04717414

  • Recruitment Status

    Recruiting

  • First Posted

    January 22, 2021

  • Last update posted

    June 9, 2021

Study Description

Brief summary:

The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period.

  • Condition or Disease:Myeloproliferative Disorders
    Myelofibrosis
    Primary Myelofibrosis
    Post-Polycythemia Vera Myelofibrosis
    Anemia
  • Intervention/Treatment: Drug: ACE-536
    Other: Placebo
  • Phase: Phase 3

Detailed Description

Permitted Concomitant Medications and Procedures - Subjects are receiving a JAK2 inhibitor for the treatment of MPN-associated MF that is approved in the country where the study is being conducted. JAK2 inhibitors are to be used according to their respective label and as prescribed as part of the subject's standard-of-care therapy as prescribed by their physician prior to study entry. - Best supportive care (BSC) includes, but is not limited to, treatment with transfusions (eg, RBC, platelet, whole blood), ICTs, antibiotic, antiviral and/or antifungal therapy, and nutritional support as needed. - Granulocyte colony-stimulating factors (ie, G-CSF, granulocyte macrophage colony-stimulating factor [GM-CSF]) are allowed only in cases of neutropenic fever or as clinically indicated per product label. - Prophylactic antithrombotic therapy is permitted. - Thrombopoietin and platelet transfusions are permitted. - Treatment with systemic corticosteroids is permitted for nonhematological conditions providing the subject is receiving a constant dose equivalent to ≤ 10 mg prednisone during the study. - Administration of attenuated vaccines (eg, influenza vaccine) is allowed if clinically indicated per Investigator discretion. - Iron chelation therapy (ICT) is to be used according to the product label. If the label permits, the ICT dose should be stable during at least the first 24 weeks of IP. Initiation of ICT while within the first 24 weeks of IP should be clinically indicated to treat an AE. Prohibited Concomitant Medications The following concomitant medications are specifically excluded during the course of the study: - Cytotoxic, chemotherapeutic, targeted, or investigational agents/therapies (excluding JAK2 inhibitor therapy) - Azacitidine, decitabine, or other hypomethylating agents - Lenalidomide, thalidomide, and pomalidomide - Erythropoietin stimulating agents (ESAs) and other RBC hematopoietic growth factors (eg, IL-3) - Hydroxyurea or other alkylating agents - Androgens (unless given to treat hypogonadism) - Oral retinoids (topical retinoids are permitted) - Arsenic trioxide - Interferon - Anagrelide - Systemic corticosteroids at a dose equivalent to > 10 mg prednisone - Investigational products for the treatment of MPN-associated MF

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 309 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK Inhibitor Therapy and Who Require Red Blood Cell Transfusions
  • Actual Study Start Date: February 2021
  • Estimated Primary Completion Date: January 2025
  • Estimated Study Completion Date: February 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Experimental Arm: Luspatercept (ACE-536)
Luspatercept will be given to participants via subcutaneous injection (administered on Day 1 of each 21-day treatment cycle)
Drug: ACE-536
Subcutaneous Injection
Placebo Comparator: Control Arm: Placebo
Placebo starting dose with volume equivalent to experimental arm subcutaneous injection every 3 weeks (administered on Day 1 of each 21-day treatment cycle)
Other: Placebo
Subcutaneous Injection

Outcome Measures

  • Primary Outcome Measures: 1. Red blood cell-transfusion independence (RBC-TI) ≥ 12 weeks (RBC-TI 12) [ Time Frame: Up to 24 weeks ]
    Proportion of subjects who become RBC-transfusion free over any consecutive 12-week period starting within the first 24 weeks.
  • Secondary Outcome Measures: 1. Red blood cell-transfusion independence ≥ 16 weeks (RBC-TI 16) [ Time Frame: Up to 24 weeks ]
    Proportion of subjects who become RBC-transfusion free over any consecutive 16-week period
  • 2. Duration of Red blood cell-transfusion independence (RBC-TI 12) [ Time Frame: Up to end of treatment, approximately 3 years ]
    Maximum duration of RBC-TI response
  • 3. Reduction of transfusion burden by ≥ 50% and by ≥ 4 units/12 weeks from baseline over any consecutive 12-week period [ Time Frame: Up to 24 weeks ]
    Proportion of subjects who reduce their transfusion burden by ≥ 50% and by ≥ 4 units/12 weeks from baseline over any consecutive 12-week period
  • 4. Duration of reduction in transfusion burden [ Time Frame: Up to end of treatment, approximately 3 years ]
    Maximum duration of when RBC-transfusion dependent subjects who reduce their transfusion burden by ≥ 50% and by ≥ 4 units/12 weeks from baseline over any consecutive 12 week period
  • 5. Red blood cell-transfusion independence ≥ 12 weeks in the treatment period (RBC-TI 12/TP) [ Time Frame: Up to end of treatment, approximately 3 years ]
    Proportion of subjects who become RBC-transfusion free over any consecutive 12-week period
  • 6. Red blood cell-transfusion independence ≥ 16 weeks in the treatment period (RBC-TI 16/TP) [ Time Frame: Up to end of treatment, approximately 3 years ]
    Proportion of subjects who become RBC-transfusion free over any consecutive 16-week period
  • 7. Change in RBC transfusion burden [ Time Frame: Up to 24 weeks ]
    Mean change in transfusion burden (RBC units) from baseline
  • 8. Cumulative duration of RBC-transfusion independence [ Time Frame: Up to end of treatment, approximately 3 years ]
    Cumulative response duration for subjects achieving multiple episodes of RBC-TI 12
  • 9. Mean Hgb increase ≥ 1 g/dL from baseline over any consecutive 12-week period in absence of RBC transfusions [ Time Frame: Up to end of treatment, approximately 3 years ]
    Proportion of subjects achieving a mean Hgb increase ≥ 1 g/dL from baseline over any consecutive 12-week period in absence of RBC transfusions
  • 10. Change in serum ferritin from baseline [ Time Frame: Up to end of treatment, approximately 3 years ]
    Change in serum ferritin
  • 11. Incidence of Adverse Events (AEs) [ Time Frame: From screening up to 42 days post last dose ]
    Number of participants with adverse events
  • 12. Transformation to blast phase: Number of subjects who transform into AML [ Time Frame: Up to approximately 5 years ]
    AML = acute myeloid leukemia
  • 13. Frequency of Antidrug antibodies (ADA) [ Time Frame: From randomization and up to including 48 weeks post first dose ]
    Will be collected for assessment of anti-drug antibodies (ADA) against Luspatercept in serum in all subjects
  • 14. Pharmacokinetics - Area Under the Concentration-Time Curve (AUC) [ Time Frame: From randomization and up to including 48 weeks post first dose ]
    Measures of luspatercept exposure area under the curve
  • 15. Pharmacokinetics - Maximum plasma concentration of drug (Cmax) [ Time Frame: From randomization and up to including 48 weeks post first dose ]
    Maximum plasma concentration of drug

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be randomized in the study:

1. Subject is ≥18 years of age at the time of signing the ICF.

2. Subject has a diagnosis of PMF according to the 2016 World Health Organization (WHO)
criteria or diagnosis of post-ET or post-PV MF according to the IWG-MRT 2007 criteria
, confirmed by the most recent local pathology report.

3. Subject is requiring RBC transfusions as defined as:

a. Average RBC-transfusion frequency: 4 to 12 RBC units/12 weeks immediately up to
randomization. There must be no interval > 6 weeks (42 days) without ≥ 1 RBC
transfusion.

b. RBC transfusions are scored in determining eligibility when given for treatment of:

- Symptomatic (ie, fatigue or shortness of breath) anemia with a pretransfusion Hgb ≤
9.5 g/dL or

- Asymptomatic anemia with a pretransfusion Hgb ≤ 7 g/dL c. RBC transfusions given
for worsening of anemia due to bleeding or infections are not scored in
determining eligibility.

4. Subjects on continuous (eg, absent of dose interruptions lasting ≥ 2 consecutive
weeks) JAK2 inhibitor therapy as approved in the country of the study site for the
treatment for MPN-associated MF as part of their standard-of-care therapy for at least
32 weeks, on stable daily dose for at least 16 weeks immediately up to the date of
randomization and anticipated to be on a stable daily dose of that JAK2 inhibitor for
at least 24 weeks after randomization.

5. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.

6. A female of childbearing potential (FCBP) for this study is defined as a female 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 (eg, has had menses at any time in the preceding 24 consecutive
months). Females of childbearing potential (FCBP)participating in the study must:

a. Have 2 negative pregnancy tests as verified by the Investigator prior to starting
study therapy. She must agree to ongoing pregnancy testing during the study, and after
end of IP. This applies even if the subject practices true abstinence* from
heterosexual contact.

b. 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,
effective contraception** without interruption, 28 days prior to starting IP, during
the study therapy (including dose interruptions), and for 12 weeks (approximately 5
times the mean terminal half-life of IP based on multiple-dose PK data) after
discontinuation of study therapy.

7. Male subjects must: 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 12 weeks (approximately 5 times the mean terminal
half-life of IP based on multiple-dose PK data) following IP discontinuation, even if
he has undergone a successful vasectomy.

* True abstinence is acceptable when it is in line with the preferred and usual
lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation,
symptothermal, postovulation methods) and withdrawal are not acceptable methods of
contraception.]

** Agreement to use highly effective methods of contraception that alone or in
combination result in a failure rate of a Pearl index of less than 1% per year when
used consistently and correctly throughout the course of the study. Such methods
include: Combined (estrogen and progestogen containing) hormonal contraception: Oral,
Intravaginal, Transdermal; Progestogen-only hormonal contraception associated with
inhibition of ovulation: Oral, Injectable hormonal contraception, Implantable hormonal
contraception; Placement of an intrauterine device (IUD); Placement of an intrauterine
hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomized partner;
Sexual Abstinence.

8. Subject must understand and voluntarily sign an ICF prior to any study-related
assessments/procedures being conducted.

9. Subject is willing and able to adhere to the study visit schedule and other protocol
requirements including the use of the electronic patient reported outcomes device.

Exclusion Criteria:

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

1. Subject with anemia from cause other than MPN-associated MForJAK2 inhibitor therapy
(eg, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic
anemia, infection, or any type of known clinically significant bleeding or
sequestration).

2. Subject use of hydroxyurea, immunomodulatory compounds such as pomalidomide,
thalidomide, ESAs, androgenic steroids or other drugs with potential effects on
hematopoiesis ≤ 8 weeks immediately up to the date of randomization.

1. Systemic corticosteroids are permitted for nonhematological conditions providing
the subject is receiving a constant dose equivalent to ≤ 10 mg prednisone for the
4 weeks immediately up to randomization.

2. Iron chelation therapy (ICT) is permitted providing the subject is receiving a
stable dose for the 8 weeks immediately up to randomization.

3. Subject with any of the following laboratory abnormalities at screening:

1. Neutrophils: 100 x 109/L

3. Platelets: the lowest allowable level as approved for the concomitant JAK2
inhibitor but not 1000 x 109/L

4. Peripheral blood myeloblasts:> 5%

5. Estimated glomerular filtration rate: 3500 mg/g)

6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT):> 3.0 x upper
limit of normal (ULN)

7. Direct bilirubin: ≥ 2 x ULN

- Higher levels are acceptable if these can be attributed to active red blood
cell precursor destruction within the bone marrow (eg, ineffective
erythropoiesis)

4. Subject with uncontrolled hypertension, defined as repeated elevations of systolic
blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, that is not resolved
at the time of randomization.

5. Subject with prior history of malignancies, other than disease under study, unless the
subject has been free of the disease for ≥ 3 years. However, subject with the
following history/concurrent conditions is allowed:

1. Basal or squamous cell carcinoma of the skin

2. Carcinoma in situ of the cervix

3. Carcinoma in situ of the breast

4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor,
nodes, metastasis [TNM] clinical staging system)

6. Subject with prior hematopoietic cell transplant or subject anticipated to receive a
hematopoietic cell transplant during the 24 weeks from the date of randomization. 7.
Subject with stroke, myocardial infarction, deep venous thrombosis, pulmonary or
arterial embolism within 6 months immediately up to the date of randomization.

8. Subject with major surgery within 2 months up to the date of randomization. Subject must
have completely recovered from any previous surgery immediately up to the date of
randomization.

9. Subject with a major bleeding event (defined as symptomatic bleeding in a critical area
or organ and/or bleeding causing a decrease in Hgb of ≥ 2 g/dL or leading to transfusion of
≥ 2 units of packed red cells) in the last 6 months prior to the date of randomization.

10.Subject with inadequately controlled heart disease and/or have a known left ventricular
ejection fraction < 35%. 11.Subject with uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment). 12.Subject with known human immunodeficiency virus (HIV), evidence of active Hepatitis B (HepB) as demonstrated by the presence of Hepatitis B surface antigen (HBsAg) and/or positive for Hepatitis B virus DNA (HBVDNA-positive), and/or evidence of active Hepatitis C (HepC) as demonstrated by a positive Hepatitis C virus RNA (HCV-RNA) test of sufficient sensitivity. 13.Subject with prior therapy of luspatercept or sotatercept. 14.Subject with history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product. 15.Pregnant or breastfeeding females. 16.Subject participation in any other clinical protocol or investigational trial that involves use of experimental therapy (including investigational agents) and/or therapeutic devices within 30 days or for investigational agents within five half-lives, whichever comes later, immediately up to the date of randomization. 17.Subject with 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 or places the subject at unacceptable risk if he/she were to participate in the study. 18.Subject with any condition or concomitant medication that confounds the ability to interpret data from the study.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations

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Graz

Austria
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Linz

Austria
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Vienna

Austria
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Wien

Belgium
AZ Sint-Jan AV Brugge
Brugge

Belgium
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Belgium
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Yvoir

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Edmonton

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Saint John

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London

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Toronto

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Montreal

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Sir Mortimer B. Davis - Jewish Genl
Montreal

Canada, Quebec
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Sherbrooke

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Nanjing

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Shanghai

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Shanghai 6th Hospital
Shanghai

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The First Affiliated Hospital of Soochow University
Suzhou

China
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Tianjin

China
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Wuhan

China
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Zhengzhou

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Vseobecna Fakultni Nemocnice v Praze
Prague 2

France
CHRU Hopital du Bocage
Angers

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Hopital Henri Mondor
Creteil

France
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Grenoble

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CHRU de Lille-Hopital Claude Huriez
Lille

France
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Lyon

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Nice

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Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
Nimes Cedex 9

France
Hopital Saint Louis
Paris Cedex 10

France
Groupe Hospitalier Sud Hopital Haut Leveque USN
Pessac

France
CHU La Miletrie
Poitiers Cedex

France
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg

France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse Cedex 9

Germany
Unviversitatsklinikum Aachen
Aachen

Germany
Stauferklinikum Schwab. Gmund
Baden-Warttemberg

Germany
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Dusseldorf

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Universitatsklinikum Halle Saale
Halle

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OncoResearch Lerchenfeld GmbH
Hamburg

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Jena

Germany
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Leipzig

Germany
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Mannheim

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Johannes Wiesling Klinikum Minden
Minden

Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster

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Alexandroupolis

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Athens

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Athens

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Tel-Aviv

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Zerifin

Italy
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Ancona

Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna

Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico
Catania

Italy
Azienda Ospedaliera Universitaria Careggi
Firenze

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Azienda Ospedaliera Universitaria Federico II
Napoli, Campania

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A.O.U. Maggiore della Carità
Novara

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Padova

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Roma

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Ospedale S Eugenio
Roma

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Varese

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Chuo

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Kamogawa

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Maebashi

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Nagasaki

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Daegu

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Hwasun-Gun

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Seongnam-si

Korea, Republic of
Samsung Medical Center
Seoul

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The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul

Korea, Republic of
Seoul National University Hospital
Seoul

Korea, Republic of
Asan Medical Center
Seoul

Poland
Uniwersyteckie Centrum Kliniczne
Gdansk

Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow

Poland
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz

Poland
ALVAMED
Poznan

Poland
Specjalistyczny Szpital im. dra Alfreda Sokolowskiego
Walbrzych

Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw

Russian Federation
FGBU NMIC of Hematology of the Ministry of Health of the Russian Federation
Moscow

Russian Federation
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
Moscow

Russian Federation
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
St Petersburg

Russian Federation
First St Petersburg State Medical University na IP Pavlov
St. Petersburg

Spain
Hospital Clinic de Barcelona
Barcelona

Spain
Hospital Universitari Germans Trias i Pujol ICO Badalona
Barcelona

Spain
Hospital Virgenes de las Nieves
Granada

Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria

Spain
Hospital Universitario Ramon y Cajal
Madrid

Spain
Hospital Universitario 12 de Octubre
Madrid

Spain
Hospital Son Espases
Palma de Mallorca

Spain
Universitario de Salamanca - Hospital Clinico
Salamanca

Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela

Spain
Hospital Universitario Virgen del Rocio
Seville

Spain
Hospital Clinico Universitario de Valencia
Valencia

United Kingdom
Heart of England NHS Foundation Trust
Birmingham

United Kingdom
United Lincolnshire Hospitals NHS Trust
Boston

United Kingdom
Guy's Cancer Centre
London

United Kingdom
Nottingham City Hospital
Nottingham

United Kingdom
Churchhill Hospital
Oxford

Sponsors and Collaborators

Celgene

Investigators

Study Director: Torsten Gerike, MD Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04717414 History of Changes
  • Other Study ID Numbers: ACE-536-MF-002, 2020-000607-36, U1111-1260-9595
  • First Posted: January 22, 2021 Key Record Dates
  • Last Update Posted: June 9, 2021
  • Last Verified: June 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Luspatercept
    ACE-536
    Myeloproliferative Neoplasm
    Myelofibrosis
    JAK2
    Red blood cell transfusion
    Post-ET MF
    Post-PV MF
    Reblozyl
    Anemia
  • Additional relevant MeSH terms: Neoplasms
    Polycythemia Vera
    Primary Myelofibrosis
    Myeloproliferative Disorders
    Polycythemia