Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04472598
Registration number
NCT04472598
Ethics application status
Date submitted
14/07/2020
Date registered
15/07/2020
Titles & IDs
Public title
Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis
Query!
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)
Query!
Secondary ID [1]
0
0
2020-000097-15
Query!
Secondary ID [2]
0
0
M16-191
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
TRANSFORM-1
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Myelofibrosis (MF)
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Navitoclax
Treatment: Drugs - Ruxolitinib
Treatment: Drugs - Placebo for Navitoclax
Experimental: Navitoclax + Ruxolitinib - Participants will receive Navitoclax in combination with Ruxolitinib
Active comparator: Placebo for Navitoclax + Ruxolitinib - Participants will receive placebo for Navitoclax and Ruxolitinib
Treatment: Drugs: Navitoclax
Tablet; Oral
Treatment: Drugs: Ruxolitinib
Tablet; Oral
Treatment: Drugs: Placebo for Navitoclax
Tablet; Oral
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)
Query!
Assessment method [1]
0
0
Reduction in spleen volume is measured by magnetic resonance imaging (MRI) or computed tomography (CT), per International Working Group (IWG) criteria.
Query!
Timepoint [1]
0
0
At Week 24
Query!
Secondary outcome [1]
0
0
Change in Total Symptom Score (TSS)
Query!
Assessment method [1]
0
0
Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
Query!
Timepoint [1]
0
0
Baseline (Week 0) Up to Week 24
Query!
Secondary outcome [2]
0
0
Percentage of Participants who achieve Spleen Volume Reduction of at least 35% (SVR35)
Query!
Assessment method [2]
0
0
Reduction in spleen volume is measured by MRI or CT, per IWG criteria.
Query!
Timepoint [2]
0
0
Baseline (Week 0) Up to Week 96
Query!
Secondary outcome [3]
0
0
Duration of 35% Spleen Volume Reduction (SVR35)
Query!
Assessment method [3]
0
0
Duration of SVR35 is defined as the time between the date of first response of spleen volume reduction of 35% achievement to the date of the first assessment where the spleen volume is less than 35% reduction from baseline and is at least 25% increase from the nadir (the lowest spleen volume).
Query!
Timepoint [3]
0
0
Baseline (Week 0) Up to Week 96
Query!
Secondary outcome [4]
0
0
Change In Fatigue
Query!
Assessment method [4]
0
0
Change in fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue SF 7a.
Query!
Timepoint [4]
0
0
Baseline (Week 0) Up to Week 24
Query!
Secondary outcome [5]
0
0
Change in Physical Functioning
Query!
Assessment method [5]
0
0
Change in physical functioning is measured by the physical functioning domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 or death.
Query!
Timepoint [5]
0
0
Baseline (Week 0) Up to Week 24
Query!
Secondary outcome [6]
0
0
Percentage of Participants who achieve Anemia Response
Query!
Assessment method [6]
0
0
The rate of anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria.
Query!
Timepoint [6]
0
0
Baseline (Week 0) Up to Week 96
Query!
Secondary outcome [7]
0
0
Overall Survival (OS)
Query!
Assessment method [7]
0
0
OS is defined as the time from the date of randomization to the date of death from any cause.
Query!
Timepoint [7]
0
0
Up To approximately 8 Years
Query!
Secondary outcome [8]
0
0
Leukemia-Free Survival
Query!
Assessment method [8]
0
0
Leukemia-free survival is defined as the number of days from the date of randomization to the onset date of documented leukemia, disease progression due to leukemia, or death due to leukemia, whichever occurs first.
Query!
Timepoint [8]
0
0
Up To approximately 8 Years
Query!
Secondary outcome [9]
0
0
Percentage of Participants who Achieve Reduction in Grade of Bone Marrow Fibrosis
Query!
Assessment method [9]
0
0
Change in grade of bone marrow fibrosis will be measured per the European consensus grading system through bone marrow biopsy.
Query!
Timepoint [9]
0
0
Baseline (Week 0) Up to Week 96
Query!
Eligibility
Key inclusion criteria
* Documented diagnosis of Primary MyeloFibrosis (MF) as defined by World Health Organization (WHO) classification or Secondary MF (post polycythemia vera [PPV] - MF or Post Essential Thrombocytopenia [PET] - MF) .
* Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days immediately preceding the date of randomization.
-- Must have at least 2 symptoms with a score >=3 or a total score of >=12, as measured by the MFSAF v4.0.
* Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
* Has splenomegaly defined as spleen palpation measurement >= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
* Ineligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant and other criteria per National Comprehensive Cancer Network guidelines.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor.
* Prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor or stem cell transplant.
* Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 milligram daily) and low molecular weight heparin (LMWH).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/09/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
29/01/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
252
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
The Kinghorn Cancer Centre /ID# 221503 - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 231311 - East Albury
Query!
Recruitment hospital [3]
0
0
Gosford Hospital /ID# 221499 - Gosford
Query!
Recruitment hospital [4]
0
0
Liverpool Hospital /ID# 221803 - Liverpool
Query!
Recruitment hospital [5]
0
0
Townsville University Hospital /ID# 229794 - Douglas
Query!
Recruitment hospital [6]
0
0
Peter MacCallum Cancer Ctr /ID# 229795 - Melbourne
Query!
Recruitment hospital [7]
0
0
Alfred Health /ID# 221501 - Melbourne
Query!
Recruitment hospital [8]
0
0
Royal Perth Hospital /ID# 223203 - Perth
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
2640 - East Albury
Query!
Recruitment postcode(s) [3]
0
0
2250 - Gosford
Query!
Recruitment postcode(s) [4]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [5]
0
0
4814 - Douglas
Query!
Recruitment postcode(s) [6]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [7]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [8]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Minnesota
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Missouri
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Jersey
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Pennsylvania
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Utah
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Virginia
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Washington
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Oberoesterreich
Query!
Country [23]
0
0
Austria
Query!
State/province [23]
0
0
Steiermark
Query!
Country [24]
0
0
Austria
Query!
State/province [24]
0
0
Wien
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Namur
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Oost-Vlaanderen
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Vlaams-Brabant
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
West-Vlaanderen
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Antwerp
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Brugge
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Liege
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Sint-Niklaas
Query!
Country [33]
0
0
Bulgaria
Query!
State/province [33]
0
0
Sofia
Query!
Country [34]
0
0
Bulgaria
Query!
State/province [34]
0
0
Pleven
Query!
Country [35]
0
0
Bulgaria
Query!
State/province [35]
0
0
Plovdiv
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Ontario
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Quebec
Query!
Country [38]
0
0
Croatia
Query!
State/province [38]
0
0
Grad Zagreb
Query!
Country [39]
0
0
Croatia
Query!
State/province [39]
0
0
Splitsko-dalmatinska Zupanija
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Auvergne-Rhone-Alpes
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Gard
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Gironde
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Hauts-de-France
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Ile-de-France
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Pays-de-la-Loire
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Savoie
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Angers
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Paris
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Strasbourg Cedex
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Baden-Wuerttemberg
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Bayern
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Nordrhein-Westfalen
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Sachsen
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Essen
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Hamburg
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Munich
Query!
Country [57]
0
0
Greece
Query!
State/province [57]
0
0
Attiki
Query!
Country [58]
0
0
Greece
Query!
State/province [58]
0
0
Athens
Query!
Country [59]
0
0
Israel
Query!
State/province [59]
0
0
Tel-Aviv
Query!
Country [60]
0
0
Israel
Query!
State/province [60]
0
0
Yerushalayim
Query!
Country [61]
0
0
Israel
Query!
State/province [61]
0
0
Be'Er Ya'Akov
Query!
Country [62]
0
0
Israel
Query!
State/province [62]
0
0
Haifa
Query!
Country [63]
0
0
Israel
Query!
State/province [63]
0
0
Kfar Saba
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Lazio
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Bergamo
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Bologna
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Brescia
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Catania
Query!
Country [69]
0
0
Italy
Query!
State/province [69]
0
0
Florence
Query!
Country [70]
0
0
Italy
Query!
State/province [70]
0
0
Varese
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Aichi
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Chiba
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Ehime
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Fukuoka
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Fukushima
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Gifu
Query!
Country [77]
0
0
Japan
Query!
State/province [77]
0
0
Gunma
Query!
Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Hokkaido
Query!
Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Hyogo
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Ibaraki
Query!
Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Ishikawa
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Kagoshima
Query!
Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Kyoto
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Mie
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Miyazaki
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Okayama
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Osaka
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Saitama
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Shizuoka
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Tokyo
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Yamanashi
Query!
Country [92]
0
0
Korea, Republic of
Query!
State/province [92]
0
0
Gyeonggido
Query!
Country [93]
0
0
Korea, Republic of
Query!
State/province [93]
0
0
Busan
Query!
Country [94]
0
0
Korea, Republic of
Query!
State/province [94]
0
0
Daegu
Query!
Country [95]
0
0
Korea, Republic of
Query!
State/province [95]
0
0
Incheon
Query!
Country [96]
0
0
Korea, Republic of
Query!
State/province [96]
0
0
Seoul
Query!
Country [97]
0
0
Netherlands
Query!
State/province [97]
0
0
Gelderland
Query!
Country [98]
0
0
Netherlands
Query!
State/province [98]
0
0
Zuid-Holland
Query!
Country [99]
0
0
Netherlands
Query!
State/province [99]
0
0
Groningen
Query!
Country [100]
0
0
Netherlands
Query!
State/province [100]
0
0
Utrecht
Query!
Country [101]
0
0
New Zealand
Query!
State/province [101]
0
0
Auckland
Query!
Country [102]
0
0
Russian Federation
Query!
State/province [102]
0
0
Moskva
Query!
Country [103]
0
0
Russian Federation
Query!
State/province [103]
0
0
Stavropol Skiy Kray
Query!
Country [104]
0
0
Russian Federation
Query!
State/province [104]
0
0
Petrozavodsk
Query!
Country [105]
0
0
Russian Federation
Query!
State/province [105]
0
0
Saint Petersburg
Query!
Country [106]
0
0
Russian Federation
Query!
State/province [106]
0
0
Sankt-Peterburg
Query!
Country [107]
0
0
Russian Federation
Query!
State/province [107]
0
0
Tula
Query!
Country [108]
0
0
Serbia
Query!
State/province [108]
0
0
Beograd
Query!
Country [109]
0
0
Serbia
Query!
State/province [109]
0
0
Sumadijski Okrug
Query!
Country [110]
0
0
Serbia
Query!
State/province [110]
0
0
Vojvodina
Query!
Country [111]
0
0
South Africa
Query!
State/province [111]
0
0
Gauteng
Query!
Country [112]
0
0
Spain
Query!
State/province [112]
0
0
A Coruna
Query!
Country [113]
0
0
Spain
Query!
State/province [113]
0
0
Barcelona
Query!
Country [114]
0
0
Spain
Query!
State/province [114]
0
0
Las Palmas
Query!
Country [115]
0
0
Spain
Query!
State/province [115]
0
0
Navarra
Query!
Country [116]
0
0
Spain
Query!
State/province [116]
0
0
Madrid
Query!
Country [117]
0
0
Spain
Query!
State/province [117]
0
0
Malaga
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Valencia
Query!
Country [119]
0
0
Sweden
Query!
State/province [119]
0
0
Orebro Lan
Query!
Country [120]
0
0
Sweden
Query!
State/province [120]
0
0
Skane Lan
Query!
Country [121]
0
0
Sweden
Query!
State/province [121]
0
0
Vastra Gotalands Lan
Query!
Country [122]
0
0
Taiwan
Query!
State/province [122]
0
0
Kaohsiung
Query!
Country [123]
0
0
Taiwan
Query!
State/province [123]
0
0
Taichung City
Query!
Country [124]
0
0
Taiwan
Query!
State/province [124]
0
0
Tainan City
Query!
Country [125]
0
0
Taiwan
Query!
State/province [125]
0
0
Taipei City
Query!
Country [126]
0
0
Taiwan
Query!
State/province [126]
0
0
Taoyuan City
Query!
Country [127]
0
0
Turkey
Query!
State/province [127]
0
0
Ankara
Query!
Country [128]
0
0
Turkey
Query!
State/province [128]
0
0
Edirne, Istanbul
Query!
Country [129]
0
0
Turkey
Query!
State/province [129]
0
0
Istanbul
Query!
Country [130]
0
0
Turkey
Query!
State/province [130]
0
0
Izmir
Query!
Country [131]
0
0
Turkey
Query!
State/province [131]
0
0
Malatya
Query!
Country [132]
0
0
Ukraine
Query!
State/province [132]
0
0
Kharkiv
Query!
Country [133]
0
0
Ukraine
Query!
State/province [133]
0
0
Kyiv
Query!
Country [134]
0
0
Ukraine
Query!
State/province [134]
0
0
Lviv
Query!
Country [135]
0
0
United Kingdom
Query!
State/province [135]
0
0
Lincolnshire
Query!
Country [136]
0
0
United Kingdom
Query!
State/province [136]
0
0
London, City Of
Query!
Country [137]
0
0
United Kingdom
Query!
State/province [137]
0
0
Oxfordshire
Query!
Country [138]
0
0
United Kingdom
Query!
State/province [138]
0
0
Birmingham
Query!
Country [139]
0
0
United Kingdom
Query!
State/province [139]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body's normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis. Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide. Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04472598
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
ABBVIE INC.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Query!
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
Query!
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/NCT04472598