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Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy. (RESPONSE-2)

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ClinicalTrials.gov Identifier: NCT02038036
Recruitment Status : Completed
First Posted : January 16, 2014
Results First Posted : July 20, 2021
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study compared the efficacy and safety of ruxolitinib to Best Available Therapy (BAT) in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and did not have a palpable spleen.

Condition or disease Intervention/treatment Phase
Polycythemia Vera Drug: Best Available Therapy Drug: Ruxolitinib Phase 3

Detailed Description:

This was a prospective, multi-center, open-label, randomized, Phase IIIb study evaluating efficacy and safety of ruxolitinib versus BAT as selected by the Investigator in patients with PV who are resistant to, or intolerant of HU.

The study comprised of the following periods:

Screening Period (up to 5 weeks: Day -35 to Day -1): Screening evaluations were performed at one or more clinic visits, and reviewed to determine eligibility before the patient was randomized in the study.

Core Treatment Period (Day 1 to Week 80):

Patients were randomized in 1:1 ratio to either treatment group (ruxolitinib or BAT) and were to be treated with their randomized treatment.

Crossover Treatment Period (Week 28 or after) for BAT patients only:

Patients randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib. Patients crossing over on or after Week 28 had to complete all assessments for the End of Treatment (EoT) visit of the Core Treatment Period followed by the assessments in Cross-over visit evaluation schedule.

Extended Treatment Period (Week 80 to Week 260):

Patients receiving ruxolitinib at Week 80 (including patients who have crossed over from BAT) were eligible to continue up to Week 260 in the Extended Treatment Period. Patients continued the ruxolitinib dose that they received at Week 80. Patients who received BAT at Week 80 were not eligible to enter the Extended Treatment Period and had to have the EoT visit at Week 80 and an End of study (EoS) visit 30 days after the EoT visit.

Follow-up Period:

Patients were followed for safety during 30 days after the last dose of study drug and EoS visit assessments were performed post 30 days after the last dose of study drug. Patients who completed EoT (Week 80 for patients who received BAT, Week 260 for patients who received ruxolitinib or from the time of premature discontinuation) were to be followed-up for every 3 months for survival till the end of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Multicenter Phase IIIb Study Evaluating the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant (Response 2)
Actual Study Start Date : March 25, 2014
Actual Primary Completion Date : September 29, 2015
Actual Study Completion Date : April 7, 2020


Arm Intervention/treatment
Experimental: Ruxolitinib
Ruxolitinib was administered at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid.
Drug: Ruxolitinib
Ruxolitinib was administered at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid.
Other Name: INC424

Active Comparator: Best Available Therapy (BAT)
Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.
Drug: Best Available Therapy
Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.
Other Name: BAT




Primary Outcome Measures :
  1. Number of Participants Achieving Hematocrit (Hct) Control at Week 28 [ Time Frame: Week 28 ]

    Proportion of patients achieving Hct control at Week 28 was defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8.

    Phlebotomy eligibility was defined by:

    • Confirmed Hct > 45% that is at least 3 percentage points higher than the Hct obtained at Baseline Or
    • Confirmed Hct > 48% The confirmation occurred 2 to 14 days subsequent to the initial observation.


Secondary Outcome Measures :
  1. Number of Participants Achieving a Complete Hematological Remission at Week 28 [ Time Frame: Week 28 ]

    Proportion of patients achieving a complete hematological remission at Week 28 was defined by:

    • Hct control at Week 28 defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and
    • WBC < 10 x109/L at Week 28, and
    • Platelets ≤ 400 x 109/L at Week 28

  2. Number of Participants Achieving a Hematocrit (Hct) Control at Week 52 and Week 80 [ Time Frame: Week 52 and 80 ]

    Proportion of patients achieving a Hct control at Week 52 was defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 52, and no more than one phlebotomy eligibility occurring post randomization and prior to Week 8

    - Endpoint for Week 80 was defined, similarly.


  3. Number of Participants Achieving a Complete Hematological Remission at Week 52 and Week 80 [ Time Frame: Week 52 and 80 ]

    Proportion of patients achieving a complete hematological remission at Week 52, was defined by:

    • Hct control at Week 52, as defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 52 with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and
    • White Blood Count (WBC) < 10 x10^9/L at Week 52, and
    • Platelets ≤ 400 x 10^9/L at Week 52
    • Endpoint for Week 80 was defined, similarly.

  4. Number of Participants With Phlebotomies Over Time [ Time Frame: Baseline to Week 260 ]
    Phlebotomy eligibility was defined by Confirmed Hct > 45% that is at least 3 percentage points higher than the Hct obtained at Baseline Or Confirmed Hct > 48%. The confirmation occurred 2 to 14 days subsequent to the initial observation.

  5. Change From Baseline in Hematocrit (Hct) at Each Visit [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 66, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234, 247 and 260 ]
    Hematocrit is the volume percentage of red blood cells (RBC) in the blood.

  6. Change From Baseline in Hematocrit (Hct) at Each Scheduled Visit After Crossover in Participants Randomized to BAT Who Cross Over to Ruxolitinib [ Time Frame: Baseline (last assessment before cross over), Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 64, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206, 219 and 232 after cross-over ]
    Hematocrit is the percentage of red blood cells (RBC) in the blood.

  7. Spleen Length by Visit [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 66, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234, 247 and 260 ]
    Spleen length was assessed by manual palpation at every study visit.

  8. Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Week 28 [ Time Frame: Baseline and Week 28 ]
    The ECOG scale of performance status described the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. The ECOG performance was recorded as per ECOG performance status grades ranging from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead).

  9. Number of Participants Achieving a Partial Remission Based on the European Leukemia Net (ELN) and International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) Criteria at Week 28 [ Time Frame: Week 28 ]

    Proportion of patients achieving a partial remission at Week 28, based on the ELN and IWG-MRT criteria, as defined by:

    • Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) score reduction of greater than or equal to 10 points from baseline to Week 28, and
    • Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and
    • WBC < 10 x10^9/L at Week 28, and
    • Platelets ≤ 400 x 10^9/L at Week 28, and
    • No palpable spleen at Week 28, and
    • No hemorrhagic or thrombotic events, and
    • No transformation into post-PV myelofibrosis, myelodysplastic syndrome (IWG-MRT criteria) or acute leukemia (WHO criteria).

  10. Number of Participants Who Achieved Partial Remission Based on the European Leukemia Net (ELN) and International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) Criteria at Week 52 and Week 80 [ Time Frame: Week 52 and 80 ]

    Proportion of patients who achieved partial remission at Week 52 based on the ELN and IWG-MRT criteria, as defined by:

    • MPN-SAF TSS score reduction of greater than or equal to 10 points from baseline to Week 52 and
    • Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 52 with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and
    • WBC < 10 x109/L at Week 52 and
    • Platelets ≤ 400 x 109/L at Week 52 and
    • No palpable spleen at Week 52 and
    • No hemorrhagic or thrombotic events, and
    • No transformation into post-PV myelofibrosis, myelodysplastic syndrome (IWG-MRT criteria) or acute leukemia (WHO criteria).
    • Endpoint for Week 80 was defined, similarly.

  11. Number of Participants Achieving a Hematocrit (Hct) Control at Week 104, Week 156, Week 208 and Week 260. [ Time Frame: From Week 8 to Week 104, 156, 208 and 260 ]
    Proportion of patients achieving a Hct control at Week 104 as defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104 and with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8 Endpoint for Week 156, Week 208 and Week 260 were defined, similarly.

  12. Number of Participants Achieving a Complete Hematological Remission at Week 104, Week 156, Week 208 and Week 260 [ Time Frame: From Week 8 to Week 104, 156, 208 and 260 ]

    Proportion of patients achieving a complete hematological remission at Week 104 as defined by Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and

    • WBC < 10 x10^9/L at Week 104, and
    • Platelets ≤ 400 x 10^9/L at Week 104 Endpoint for Week 156, Week 208 and Week 260 were defined, similarly.

  13. Number of Participants Who Achieved Partial Remission Based on the European Leukemia Net (ELN) and International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) Criteria at Week 104, Week 156, Week 208 and Week 260. [ Time Frame: From Week 8 to Week 104, 156, 208 and 260 ]

    Proportion of patients who achieved partial remission at Week 104, based on the ELN and IWG-MRT criteria, as defined by:

    • MPN-SAF TSS score reduction of greater than or equal to 10 points from baseline to Week 104, and
    • Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104, with no more than one phlebotomy eligibility occurring post-randomization and prior to Week 8, and
    • WBC < 10 x10^9/L at Week 104, and
    • Platelets ≤ 400 x 10^9/L at Week 104, and
    • No palpable spleen at Week 104, and
    • No hemorrhagic or thrombotic events, and
    • No transformation into post-PV myelofibrosis, myelodysplastic syndrome (IWG-MRT criteria) or acute leukemia (WHO criteria) Endpoint for Week 156, Week 208 and Week 260 are defined, similarly.

  14. Number of Participants With Transformation Free Survival Events [ Time Frame: Week 260 (ruxolitinib arm) and Week 80 (BAT arm) ]

    Transformation-free survival is defined as one of the following:

    1. Myelofibrosis (MF) as evidenced by bone marrow biopsy, or
    2. Acute leukemia as evidenced by bone marrow blast counts of at least 20%, or peripheral blast counts of at least 20% lasting at least 2 weeks.
    3. Death due to any cause during treatment period

  15. Number of Participants With Overall Survival (OS) Events [ Time Frame: up to Week 260 ]
    Overall survival (OS) event is defined as death due to any cause. OS events were counted in the BAT arm, irrespective of whether participants crossed over to receive ruxolitinib when the event occurred.

  16. Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) [ Time Frame: Baseline, Week 4, 8, 16, 28, 40, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 ]
    The MPN-SAF TSS is a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms. Each item is scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable).The MPN-SAF TSS is computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale. The MPN-SAF TSS thus has a possible score range of 0 to 100 where a decrease indicates improvement.

  17. Change From Baseline in Total Scores of MPN-SAF by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover [ Time Frame: Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 40, 52, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 after cross-over ]
    The MPN-SAF TSS is a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms. Each item is scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable).The MPN-SAF TSS is computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale. The MPN-SAF TSS thus has a possible score range of 0 to 100 where a decrease indicates improvement.

  18. Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-level (EQ-5D-5L) Questionnaire [ Time Frame: Baseline, Week 4, 8, 16, 28, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 ]
    EQ-5D-5L is a standardized instrument for measuring health outcomes in a wide range of health conditions and treatments. It consists of visual analogue scale (EQ VAS) which records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'Best imaginable health state' and 'worst imaginable health state'. The EQ VAS scores were anchored on 100 = the best health you can imagine and 0 = worst health you can imagine.

  19. Change From Baseline in EQ-5D-5L VAS, by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover [ Time Frame: Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 52, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 after cross-over ]
    EQ-5D-5L is a standardized instrument for measuring health outcomes in a wide range of health conditions and treatments. It consists of visual analogue scale (EQ VAS) which records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'Best imaginable health state' and 'worst imaginable health state'. The EQ VAS scores were anchored on 100 = the best health you can imagine and 0 = worst health you can imagine.

  20. Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire [ Time Frame: Baseline, Week 4, 8, 16, 28, 52 and 80 ]

    The Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) is a six item questionnaire which intended to measure work and activity impairment associated with polycythemia vera. WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the polycythemia vera; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the polycythemia vera on productivity while working; Q6=Impact of the polycythemia vera on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. Scores were multiplied by 100 to express in percentages.

    Percent work time missed due to problem (past 7 days) =Q2/(Q2+Q4) Percent impairment while working due to problem (past 7 days): Q5/10 Percent overall work impairment due to problem (past 7 says): Q2/(Q2+Q4)+[(1 Q2/(Q2+Q4))x(Q5/10)] Percent activity impairment due to problem (past 7 says): Q6/10


  21. Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI), by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover [ Time Frame: Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28 and 52 after cross-over ]

    The Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) is a six item questionnaire which intended to measure work and activity impairment associated with polycythemia vera. WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the polycythemia vera; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the polycythemia vera on productivity while working; Q6=Impact of the polycythemia vera on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. Scores were multiplied by 100 to express in percentages.

    Percent work time missed due to problem (past 7 days) =Q2/(Q2+Q4) Percent impairment while working due to problem (past 7 days): Q5/10 Percent overall work impairment due to problem (past 7 says): Q2/(Q2+Q4)+[(1 Q2/(Q2+Q4))x(Q5/10)] Percent activity impairment due to problem (past 7 says): Q6/10


  22. Patient Global Impression of Change (PGIC) [ Time Frame: Week 4, 8, 16, 28, 40, 52 and 80 ]
    The Patient Global Impression of Change (PGIC) is comprised of a single question intended to measure a patient's perspective of improvement or deterioration over time relative to treatment. The PGIC uses a seven-point scale where one (1) equals very much improved and seven (7) equals very much worse.

  23. Summary of Patient Global Impression of Change (PGIC), by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover [ Time Frame: Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 40, and 52 after cross-over ]
    The Patient Global Impression of Change (PGIC) is comprised of a single question intended to measure a patient's perspective of improvement or deterioration over time relative to treatment. The PGIC uses a seven-point scale where one (1) equals very much improved and seven (7) equals very much worse.

  24. Number of Participants Developing Thrombosis [ Time Frame: From randomization to Week 80 for BAT and Week 260 for Ruxolitinib ]
    Proportion of participants developing any arterial or venous thromboembolic event



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

Confirmed diagnosis of PV according to the 2008 World Health Organization criteria, Non-palpable spleen, Phlebotomy dependent, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1 or 2.

Exclusion Criteria:

Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral infection requiring treatment, Active malignancy within the past 5 years, excluding specific skin cancers, Previously received treatment with a JAK inhibitor, Being treated with any investigational agent, Women who are pregnant or nursing.

Other inclusion/exclusion criteria apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038036


Locations
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Australia, Queensland
Novartis Investigative Site
Herston, Queensland, Australia, 4029
Belgium
Novartis Investigative Site
Antwerpen, Belgium, 2060
Novartis Investigative Site
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M4N 3M5
France
Novartis Investigative Site
Bayonne, Bayonne Cedex, France, 64109
Novartis Investigative Site
Bordeaux, France, 33076
Novartis Investigative Site
Brest, France, 29200
Novartis Investigative Site
Lille cedex, France, 59020
Novartis Investigative Site
Nice Cedex, France, 06202
Novartis Investigative Site
Paris, France, 75010
Novartis Investigative Site
Toulouse, France, 31059
Germany
Novartis Investigative Site
Mannheim, Baden-Wuerttemberg, Germany, 68305
Novartis Investigative Site
Augsburg, Germany, 86150
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Jena, Germany, 07740
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Magdeburg, Germany, 39120
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Minden, Germany, 32429
Novartis Investigative Site
Ulm, Germany, 89081
Hungary
Novartis Investigative Site
Budapest, Hungary, 1085
Novartis Investigative Site
Debrecen, Hungary, 4032
Novartis Investigative Site
Kaposvar, Hungary, 7400
India
Novartis Investigative Site
Mumbai, Maharashtra, India, 400012
Novartis Investigative Site
Vellore, Tamil Nadu, India, 632 004
Israel
Novartis Investigative Site
Nahariya, Israel, 22100
Novartis Investigative Site
Netanya, Israel, 42150
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Italy
Novartis Investigative Site
Bologna, BO, Italy, 40138
Novartis Investigative Site
Firenze, FI, Italy, 50134
Novartis Investigative Site
Roma, Lazio, Italy, 00168
Novartis Investigative Site
Milano, MI, Italy, 20122
Novartis Investigative Site
Pavia, PV, Italy, 27100
Novartis Investigative Site
Torino, TO, Italy, 10126
Novartis Investigative Site
Varese, VA, Italy, 21100
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of, 03080
Novartis Investigative Site
Seoul, Korea, Republic of, 03722
Spain
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Salamanca, Castilla Y Leon, Spain, 37007
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Alicante, Comunidad Valenciana, Spain, 03010
Novartis Investigative Site
La Coruna, Galicia, Spain, 15006
Novartis Investigative Site
Las Palmas de Gran Canaria, Las Palmas De G.C, Spain, 35010
Novartis Investigative Site
Pamplona, Navarra, Spain, 31008
Novartis Investigative Site
Madrid, Spain, 28034
Novartis Investigative Site
Madrid, Spain, 28046
Turkey
Novartis Investigative Site
Izmir, Turkey, 35040
Novartis Investigative Site
Talas / Kayseri, Turkey, 38039
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02038036    
Other Study ID Numbers: CINC424B2401
First Posted: January 16, 2014    Key Record Dates
Results First Posted: July 20, 2021
Last Update Posted: July 20, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Polycythemia Vera
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hydroxyurea
INC424
Ruxolitinib
Additional relevant MeSH terms:
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Polycythemia Vera
Polycythemia
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Bone Marrow Diseases
Myeloproliferative Disorders