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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04717414




Registration number
NCT04717414
Ethics application status
Date submitted
29/12/2020
Date registered
22/01/2021

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2020-000607-36
Secondary ID [2] 0 0
ACE-536-MF-002
Universal Trial Number (UTN)
Trial acronym
INDEPENDENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myeloproliferative Disorders 0 0
Myelofibrosis 0 0
Primary Myelofibrosis 0 0
Post-Polycythemia Vera Myelofibrosis 0 0
Anemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ACE-536
Other interventions - Placebo

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)

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)


Treatment: Drugs: ACE-536
Subcutaneous Injection

Other interventions: Placebo
Subcutaneous Injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Red blood cell-transfusion independence (RBC-TI) = 12 weeks (RBC-TI 12)
Timepoint [1] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Red blood cell-transfusion independence = 16 weeks (RBC-TI 16)
Timepoint [1] 0 0
Up to 24 weeks
Secondary outcome [2] 0 0
Duration of Red blood cell-transfusion independence (RBC-TI 12)
Timepoint [2] 0 0
Up to end of treatment, approximately 3 years
Secondary outcome [3] 0 0
Reduction of transfusion burden by = 50% and by = 4 units/12 weeks from baseline over any consecutive 12-week period
Timepoint [3] 0 0
Up to 24 weeks
Secondary outcome [4] 0 0
Duration of reduction in transfusion burden
Timepoint [4] 0 0
Up to end of treatment, approximately 3 years
Secondary outcome [5] 0 0
Red blood cell-transfusion independence = 12 weeks in the treatment period (RBC-TI 12/TP)
Timepoint [5] 0 0
Up to end of treatment, approximately 3 years
Secondary outcome [6] 0 0
Red blood cell-transfusion independence = 16 weeks in the treatment period (RBC-TI 16/TP)
Timepoint [6] 0 0
Up to end of treatment, approximately 3 years
Secondary outcome [7] 0 0
Change in RBC transfusion burden
Timepoint [7] 0 0
Up to 24 weeks
Secondary outcome [8] 0 0
Cumulative duration of RBC-transfusion independence
Timepoint [8] 0 0
Up to end of treatment, approximately 3 years
Secondary outcome [9] 0 0
Mean Hgb increase = 1 g/dL from baseline over any consecutive 12-week period in absence of RBC transfusions
Timepoint [9] 0 0
Up to end of treatment, approximately 3 years
Secondary outcome [10] 0 0
Change in serum ferritin from baseline
Timepoint [10] 0 0
Up to end of treatment, approximately 3 years
Secondary outcome [11] 0 0
Incidence of Adverse Events (AEs)
Timepoint [11] 0 0
From screening up to 42 days post last dose
Secondary outcome [12] 0 0
Transformation to blast phase: Number of subjects who transform into AML
Timepoint [12] 0 0
Up to approximately 5 years
Secondary outcome [13] 0 0
Frequency of Antidrug antibodies (ADA)
Timepoint [13] 0 0
From randomization and up to including 48 weeks post first dose
Secondary outcome [14] 0 0
Pharmacokinetics - Area Under the Concentration-Time Curve (AUC)
Timepoint [14] 0 0
From randomization and up to including 48 weeks post first dose
Secondary outcome [15] 0 0
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Timepoint [15] 0 0
From randomization and up to including 48 weeks post first dose

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

Inclusion Criteria

- Subject is =18 years of age at the time of signing the ICF.

* 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.
* Subject is requiring RBC transfusions as defined as:.

i) 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.

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

A. Symptomatic (ie, fatigue or shortness of breath) anemia with a pretransfusion Hgb = 9.5 g/dL or.

B. Asymptomatic anemia with a pretransfusion Hgb = 7 g/dL.

iii) RBC transfusions given for worsening of anemia due to bleeding or infections are not scored in determining eligibility.

- 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.

* Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of = 2.
* 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:.

i) 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.

ii) 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.

- 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.

i) 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.].

ii) 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.

* Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

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

i) 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.

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

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

i) Neutrophils: < 1 x 10^9/L.

ii) White blood count (WBC): > 100 x 10^9/L.

iii) Platelets: the lowest allowable level as approved for the concomitant JAK2 inhibitor but not < 25 x 10^9/L or > 1000 x 10^9/L.

iv) Peripheral blood myeloblasts:> 5%.

v) Estimated glomerular filtration rate:< 30 mL/min/1.73 m2 (via the 4-variable modification of diet in renal disease [MDRD] formula) or nephrotic subjects (eg, urine albumin-to-creatinine ratio > 3500 mg/g).

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

vii) Direct bilirubin: = 2 x ULN.

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

* 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.
* 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:.

i) Basal or squamous cell carcinoma of the skin.

ii) Carcinoma in situ of the cervix.

iii) Carcinoma in situ of the breast.

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

* 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.
* 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.
* 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.
* Subject with inadequately controlled heart disease and/or have a known left ventricular ejection fraction < 35%.
* 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).
* 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.
* Subject with prior therapy of luspatercept or sotatercept.
* Subject with history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product.
* Pregnant or breastfeeding females.
* 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.
* 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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/08/2025
Actual
Sample size
Target
309
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [4] 0 0
Gosford Hospital - Gosford
Recruitment hospital [5] 0 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Florida
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Graz
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Ogaki
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Sapporo
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Toyohashi
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Daegu
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Hwasun-Gun
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Seongnam-si
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Seoul
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Brasov
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Cluj-Napoca
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Russian Federation
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Moscow
Country [144] 0 0
Russian Federation
State/province [144] 0 0
St Petersburg
Country [145] 0 0
Russian Federation
State/province [145] 0 0
St. Petersburg
Country [146] 0 0
Spain
State/province [146] 0 0
Barcelona
Country [147] 0 0
Spain
State/province [147] 0 0
Granada
Country [148] 0 0
Spain
State/province [148] 0 0
Las Palmas de Gran Canaria
Country [149] 0 0
Spain
State/province [149] 0 0
Madrid
Country [150] 0 0
Spain
State/province [150] 0 0
Palma de Mallorca
Country [151] 0 0
Spain
State/province [151] 0 0
Salamanca
Country [152] 0 0
Spain
State/province [152] 0 0
Santiago de Compostela
Country [153] 0 0
Spain
State/province [153] 0 0
Seville
Country [154] 0 0
Spain
State/province [154] 0 0
Valencia
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Nottinghamshire
Country [156] 0 0
United Kingdom
State/province [156] 0 0
Birmingham
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Boston
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04717414