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The Ruxo-BEAT Trial in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia (Ruxo-BEAT)

Primary Purpose

Polycythemia Vera (PV), Essential Thrombocythemia (ET)

Status
Active
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Ruxolitinib
BAT
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycythemia Vera (PV)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects must provide written informed consent prior to performance of studyspecific procedures or assessments which are not routinely performed for diagnosis or monitoring of PV or ET, and the subjects must be willing to comply with treatment and to follow up assessments and procedures
  2. Patient must be 18 years of age or older
  3. Patient´s ECOG performance status must be 0-2
  4. Patient must fulfill WHO 2008 diagnostic criteria for either polycythemia vera (PV) or essential thrombocythemia (ET). Moreover, PV- and ET-patients have to be classified as high risk according to defined criteria. For patients with high risk PV OR PV with indication for cytoreductive therapy due to progressive myeloproliferation, AT LEAST ONE of the following must be fulfilled (according to DGHO onkopedia) (Barbui, et al., 2011). (Passamonti, 2009):

    • Age >60 years
    • Previous documented thrombosis or thromboembolism
    • Platelet count > 1500 x 109/L
    • Poor tolerance of phlebotomy or frequent phlebotomy requirement
    • Symptomatic or progressive splenomegaly
    • Severe disease-related symptoms (according to the investigators definition)
    • Progressive leukocytosis with leukocyte count > 20 x 109/L For patients with high risk ET, AT LEAST ONE of the following must be fulfilled (according to DGHO guidelines):
    • Age > 60 years
    • Platelet count> 1500 x 109/L
    • Previous thrombosis or thromboembolism
    • Previous severe hemorrhage related to ET (defined as decrease of Hgb of at least 2 g/dl)
  5. Patients must fulfill the following criteria regarding prior therapy:

    PV patients:

    Never treated with cytoreductive drugs except short-term therapy (up to 6 weeks maximum) with ONE of the following drugs: hydroxyurea, anagrelide, or interferon (phlebotomy and/or aspirin are allowed)

    ET patients:

    Naïve and pretreated patients may be entered in this trial.

  6. Patient must have adequate liver function as indicated by a total bilirubin, AST, and ALT ≤ 2 the institutional ULN value, unless directly attributable to the patient's MPN
  7. Patient must have a creatinine clearance >40ml/min calculated according to the modified formula of Cockcroft and Gault, eGFR, or directly measured after 24h-urine collection
  8. Able to swallow and retain oral medication

Exclusion Criteria:

  1. Patients who meet criteria for post PV-MF or post ET-MF (IWG-MRT)
  2. Patients who have received previous ruxolitinib treatment
  3. Patients who have a history of anaphylaxis following exposure to the BAT drug of choice
  4. Patients who have an inadequate bone marrow reserve as demonstrated by ANC ≤ 1 x 109/l OR platelet count <50 x 109/l
  5. Patients who have known hepatitis B or C or HIV infection
  6. Patients who suffer from other severe, concurrent diseases, including tuberculosis, serious cardiac functional dysfunction (class III or IV as defined by the New York Heart Association Classification), uncontrolled diabetes, uncontrolled hypertension, severe pulmonary disease (i.e. COPD with hypoxemia), or major organ malfunction that could interfere with the patient's ability to participate in the study
  7. Patients who have history of active substance or alcohol abuse within the last year
  8. Female patients who are pregnant or nursing
  9. Patients who have participated in another interventional trial and/or used investigational agents or concurrent anticancer treatment for concomitant disease within the last 4 weeks of registration
  10. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up prohibits inclusion into this study
  11. Subjects who have had an active malignancy during the previous 3 years except for treated cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin, each with no evidence for recurrence in the past 3 years
  12. Patients who have uncontrolled bacterial, viral, or fungal infection
  13. Patients who have any medical condition requiring prolonged use of oral corticosteroids with a dose of more than 20 mg per day (> 1 month)
  14. Patients who have severe cerebral dysfunction and/or legal incapacity
  15. Patients who have had active splanchnic vein thrombosis within the last 3 months (includes Budd-Chiari, portal vein, splenic and mesenteric thrombosis)
  16. Patients who have thyroid dysfunction which is not adequately controlled
  17. Fertile men or women of childbearing potential cannot be included unless they are:

    • surgically sterile or > 2 years after the onset of menopause and/or
    • willing to use a highly effective contraceptive method (Pearl Index <1) such as oral contraceptives, intrauterine device, sexual abstinence, or barrier method of contraception (i.e. condoms) in conjunction with spermicidal jelly during study treatment
  18. Patients who are taking any of the following prohibited medication:

    • clarithromycin, telithromycin, troleandomycin (antibiotics)
    • ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (HIV protease inhibitors)
    • itraconazole, ketoconazole, voriconazole, fluconazole (antifungals)
  19. Patients with a diagnosis of galactose or lactose intolerance or a glucosegalactose- malabsortion

Sites / Locations

  • Universitätsmedizin Mannheim III. Medizinische Klinik Hämatologie und Internistische Onkologie
  • Universitätsklinikum Ulm Klinik für Innere Medizin III
  • Rems-Murr Klinikum Winnenden
  • Studienzentrum Aschaffenburg
  • III. Medizinischen Klinik des Klinikums rechts der Isar der TU München
  • Klinikum Nürnberg Nord Medizinische Klinik 5
  • Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik
  • Universitätsklinikum Bonn Medizinische Klinik und Poliklinik III
  • Johanniter-Krankenhaus Rheinhausen GmbH Hämatologie / Internistische Onkologie / Tagesklinik
  • Universitätsklinikum Düsseldorf Klinik für Hämatologie, Onkologie und Klinische Immunologie
  • Universitätsklinikum Essen Klinik für Hämatologie
  • Mühlenkreiskliniken Johannes Wesling Klinikum Minden Klinik für Hämatologie, Onkologie und Palliativmedizin
  • Marienhospital
  • Uniklinik RWTH Aachen
  • Universitätsklinikum Magdeburg
  • Universitätsklinikum Halle (Saale)
  • Klinikum Chemnitz gGmbH Klinik für Innere Medizin III
  • Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I
  • Universitätsklinikum Freiburg - Klinik für Innere Medizin I
  • Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Onkologie, Hämatologie und KMT mit Sektion Pneumologie
  • Universitätsklinik Jena - Klinik für Innere Medizin II
  • Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik I
  • UNIVERSITÄTSKLINIKUM Schleswig-Holstein - Klinik für Hämatologie und Onkologie, Campus Lübeck

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ruxolitinib

Best available therapy (BAT)

Arm Description

Ruxolitinib will be administered orally at a dose of 10 mg twice daily (both PV and ET) for two consecutive years.

BAT may include all currently used treatment options. BAT is at the choice of the investigator (monotherapy with i.e. hydroxyurea, anagrelide, interferon, busulfan, immunomodulators etc). BAT will be administrated for two consecutive years.

Outcomes

Primary Outcome Measures

The rate of complete clinicohematologic response rate (CHR) as defined by Barosi et al 2009

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The complete response rate (CR) at month 6 as defined by Barosi et al Blood 2013 (revised ELN response criteria)
The rate of complete responses (CHR) at month 12 as defined by Barosi et al Blood 2009
The efficacy as assessed by the absence of phlebotomy (Hct <45%)
The efficacy as assessed by the reduction in spleen size (palpable spleen that is reduced by > 50% from baseline measured by palpation and ultrasound) OR platelet count < 600 x 10^9/l (ET)
Proportion of subjects achieving both durable absence of phlebotomy eligibility AND durable spleen volume reduction measured by palpation and ultrasound (PV) OR durable platelet count <600 x 10^9/l (ET) (durable defined as >3 months) {Barosi et al 2013)
The rate of overall clinicohematologic remissions (CR + PR) according to both guidelines (Barosi et al 2009 and 2013)
Safety of both regimen
Adverse events will be assessed according to CTCAE 4.0 throughout the study until 30 days after EoT for patients in both regimens

Full Information

First Posted
October 1, 2015
Last Updated
October 26, 2022
Sponsor
RWTH Aachen University
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02577926
Brief Title
The Ruxo-BEAT Trial in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia
Acronym
Ruxo-BEAT
Official Title
Ruxolitinib Versus Best Available Therapy in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia - The Ruxo-BEAT Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
Collaborators
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Philadelphia chromosome negative myeloproliferative neoplasms (MPN) comprise a group of clonal hematological malignancies that are characterized by chronic myeloproliferation, splenomegaly, different degrees of bone marrow fibrosis, and disease-related symptoms including pruritus, night sweats, fever, weight loss, cachexia, and diarrhea. In addition, due to elevated numbers of leucocytes, erythrocytes and/or platelets, the disease course can be complicated by thromboembolic disease, hemorrhage, and leukemic transformation as well as myelofibrosis. Patients with polycythemia vera (PV) typically harbor an increased number of blood cells from all three hematopoietic cell lineages due to clonal amplification of hematopoetic stem cells, while patients with essential thrombocythemia (ET) typically show a predominant expansion of the megakaryocytic lineage. Most patients with PV below the age of 60 years are currently being treated with acetylsalicylic acid +/- phlebotomy only, and patients with low-risk ET have an almost normal life expectancy and often do not require specific treatment. However, PV- as well as ET-patients with a higher risk for complications require cytoreductive treatment. In addition, constitutional symptoms can be unbearable to patients even in the absence of bona fide high risk factors, and these patients may similarly benefit from antineoplastic therapy.
Detailed Description
Polycythemia vera (PV) and essential thrombocythemia (ET) are classical Philadelphia-negative myeloproliferative neoplasms (MPN) that are characterized by an excess of cells in the peripheral blood, clonal bone marrow hyperplasia, and extramedullary hematopoiesis. The symptoms of these patients may range from asymptomatic disease to symptomatic disease that may significantly affect their activities of daily living, such as severe generalized pruritus, night sweats and fevers, erythromelalgia, bone and muscle pain, weight loss, and fatigue. Moreover, the patients may develop thromboembolic and hemorrhagic complications, transition to myelofibrosis (MF), and transformation to acute leukemia. In principle, the only potentially curative therapy for MPNs is allogenic stem cell transplantation (allo-SCT). However, due to significant transplant-associated morbidity and mortality, this therapeutic option is only applied in exceptional cases of ET or PV. The majority of patients do not qualify for allo-SCT since the risks of this treatment clearly outweigh the potential benefits. Moreover, even with a non-transplantation approach, patients with ET and PV have a life expectancy comparable to or close to healthy age-matched control persons. For patients with standard risk PV, phlebotomy and acetylsalicylic acid are standard of care (target hematocrit below 45 %), while patients with standard risk ET should receive either no specific treatment or acetylsalicylic acid (provided that no microvascular symptoms or secondary acquired von Willebrand syndrome are present). However, in patients who are at high risk to develop thromboembolic or hemorrhagic complications (high-risk patients), cytoreductive treatment is generally indicated to prevent these potentially life-threatening complications. In PV and ET, high risk patients are characterized by advanced age (> 60 years) and / or a history of thromboembolic or hemorrhagic events {1,2,3}. In ET, a platelet count > 1500 x 109/l is associated with an increased risk of bleeding, and thus should result in a platelet lowering treatment {2}. In PV, in addition to the risk-score based therapy, cytoreduction is also required in patients with progressive or marked myeloproliferation (leukocytosis, thrombocytosis, symptomatic splenomegaly, increase of frequency of phlebotomy requirement), or devastating constitutional symptoms {1,2,4}. In Germany, best available therapy (BAT) includes approved drugs such as hydroxyurea (HU; approved for both PV and ET) and anagrelide (approved for second-line treatment of ET) and non-approved options such as alpha-interferon, pipobroman, busulfan (in elderly patients), and radioactive phosphorus (32P). In rare cases, patients may also benefit from splenic irradiation or splenectomy. Ruxolitinib is a JAK1/2-specific tyrosine kinase inhibitor (TKI) which has been approved for the treatment of symptomatic myelofibrosis. The compound was shown to be superior to hydroxyurea in reducing splenomegaly and constitutional symptoms. Ruxolitinib is currently studied in phase 2 and phase 3 clinical trials for HU-resistant or HU-intolerant PV and ET. The aim of the present study is to assess the feasibility, efficacy, and safety of ruxolitinib treatment vs. BAT in patients with high-risk PV or -ET.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycythemia Vera (PV), Essential Thrombocythemia (ET)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ruxolitinib
Arm Type
Experimental
Arm Description
Ruxolitinib will be administered orally at a dose of 10 mg twice daily (both PV and ET) for two consecutive years.
Arm Title
Best available therapy (BAT)
Arm Type
Active Comparator
Arm Description
BAT may include all currently used treatment options. BAT is at the choice of the investigator (monotherapy with i.e. hydroxyurea, anagrelide, interferon, busulfan, immunomodulators etc). BAT will be administrated for two consecutive years.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Other Intervention Name(s)
Study drug, Jakavi
Intervention Description
Ruxolitinib is a JAK1/2-specific tyrosine kinase inhibitor (TKI) which has been approved for the treatment of symptomatic myelofibrosis. The compound was shown to be superior to hydroxyurea in reducing splenomegaly and constitutional symptoms.
Intervention Type
Drug
Intervention Name(s)
BAT
Other Intervention Name(s)
Control Treatment
Intervention Description
BAT is at the choice of the investigator (monotherapy with i.e. hydroxyurea, anagrelide, interferon, busulfan, immunomodulators etc).
Primary Outcome Measure Information:
Title
The rate of complete clinicohematologic response rate (CHR) as defined by Barosi et al 2009
Time Frame
at month 6
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
at month 6 and 12
Title
The complete response rate (CR) at month 6 as defined by Barosi et al Blood 2013 (revised ELN response criteria)
Time Frame
month 6
Title
The rate of complete responses (CHR) at month 12 as defined by Barosi et al Blood 2009
Time Frame
month 12
Title
The efficacy as assessed by the absence of phlebotomy (Hct <45%)
Time Frame
through study completion, an average of 2 years
Title
The efficacy as assessed by the reduction in spleen size (palpable spleen that is reduced by > 50% from baseline measured by palpation and ultrasound) OR platelet count < 600 x 10^9/l (ET)
Time Frame
through study completion, an average of 2 years
Title
Proportion of subjects achieving both durable absence of phlebotomy eligibility AND durable spleen volume reduction measured by palpation and ultrasound (PV) OR durable platelet count <600 x 10^9/l (ET) (durable defined as >3 months) {Barosi et al 2013)
Time Frame
through study completion, an average of 2 years
Title
The rate of overall clinicohematologic remissions (CR + PR) according to both guidelines (Barosi et al 2009 and 2013)
Time Frame
through study completion, an average of 2 years
Title
Safety of both regimen
Description
Adverse events will be assessed according to CTCAE 4.0 throughout the study until 30 days after EoT for patients in both regimens
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must provide written informed consent prior to performance of studyspecific procedures or assessments which are not routinely performed for diagnosis or monitoring of PV or ET, and the subjects must be willing to comply with treatment and to follow up assessments and procedures Patient must be 18 years of age or older Patient´s ECOG performance status must be 0-2 Patient must fulfill WHO 2008 diagnostic criteria for either polycythemia vera (PV) or essential thrombocythemia (ET). Moreover, PV- and ET-patients have to be classified as high risk according to defined criteria. For patients with high risk PV OR PV with indication for cytoreductive therapy due to progressive myeloproliferation, AT LEAST ONE of the following must be fulfilled (according to DGHO onkopedia) (Barbui, et al., 2011). (Passamonti, 2009): Age >60 years Previous documented thrombosis or thromboembolism Platelet count > 1500 x 109/L Poor tolerance of phlebotomy or frequent phlebotomy requirement Symptomatic or progressive splenomegaly Severe disease-related symptoms (according to the investigators definition) Progressive leukocytosis with leukocyte count > 20 x 109/L For patients with high risk ET, AT LEAST ONE of the following must be fulfilled (according to DGHO guidelines): Age > 60 years Platelet count> 1500 x 109/L Previous thrombosis or thromboembolism Previous severe hemorrhage related to ET (defined as decrease of Hgb of at least 2 g/dl) Patients must fulfill the following criteria regarding prior therapy: PV patients: Never treated with cytoreductive drugs except short-term therapy (up to 6 weeks maximum) with ONE of the following drugs: hydroxyurea, anagrelide, or interferon (phlebotomy and/or aspirin are allowed) ET patients: Naïve and pretreated patients may be entered in this trial. Patient must have adequate liver function as indicated by a total bilirubin, AST, and ALT ≤ 2 the institutional ULN value, unless directly attributable to the patient's MPN Patient must have a creatinine clearance >40ml/min calculated according to the modified formula of Cockcroft and Gault, eGFR, or directly measured after 24h-urine collection Able to swallow and retain oral medication Exclusion Criteria: Patients who meet criteria for post PV-MF or post ET-MF (IWG-MRT) Patients who have received previous ruxolitinib treatment Patients who have a history of anaphylaxis following exposure to the BAT drug of choice Patients who have an inadequate bone marrow reserve as demonstrated by ANC ≤ 1 x 109/l OR platelet count <50 x 109/l Patients who have known hepatitis B or C or HIV infection Patients who suffer from other severe, concurrent diseases, including tuberculosis, serious cardiac functional dysfunction (class III or IV as defined by the New York Heart Association Classification), uncontrolled diabetes, uncontrolled hypertension, severe pulmonary disease (i.e. COPD with hypoxemia), or major organ malfunction that could interfere with the patient's ability to participate in the study Patients who have history of active substance or alcohol abuse within the last year Female patients who are pregnant or nursing Patients who have participated in another interventional trial and/or used investigational agents or concurrent anticancer treatment for concomitant disease within the last 4 weeks of registration Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up prohibits inclusion into this study Subjects who have had an active malignancy during the previous 3 years except for treated cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin, each with no evidence for recurrence in the past 3 years Patients who have uncontrolled bacterial, viral, or fungal infection Patients who have any medical condition requiring prolonged use of oral corticosteroids with a dose of more than 20 mg per day (> 1 month) Patients who have severe cerebral dysfunction and/or legal incapacity Patients who have had active splanchnic vein thrombosis within the last 3 months (includes Budd-Chiari, portal vein, splenic and mesenteric thrombosis) Patients who have thyroid dysfunction which is not adequately controlled Fertile men or women of childbearing potential cannot be included unless they are: surgically sterile or > 2 years after the onset of menopause and/or willing to use a highly effective contraceptive method (Pearl Index <1) such as oral contraceptives, intrauterine device, sexual abstinence, or barrier method of contraception (i.e. condoms) in conjunction with spermicidal jelly during study treatment Patients who are taking any of the following prohibited medication: clarithromycin, telithromycin, troleandomycin (antibiotics) ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (HIV protease inhibitors) itraconazole, ketoconazole, voriconazole, fluconazole (antifungals) Patients with a diagnosis of galactose or lactose intolerance or a glucosegalactose- malabsortion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Koschmieder, Prof. Dr.
Organizational Affiliation
RWTH University Hospital MK4
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsmedizin Mannheim III. Medizinische Klinik Hämatologie und Internistische Onkologie
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitätsklinikum Ulm Klinik für Innere Medizin III
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Rems-Murr Klinikum Winnenden
City
Winnenden
State/Province
Baden-Württemberg
ZIP/Postal Code
71364
Country
Germany
Facility Name
Studienzentrum Aschaffenburg
City
Aschaffenburg
State/Province
Bayern
ZIP/Postal Code
63739
Country
Germany
Facility Name
III. Medizinischen Klinik des Klinikums rechts der Isar der TU München
City
Müchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum Nürnberg Nord Medizinische Klinik 5
City
Nürnberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Facility Name
Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik
City
Mainz
State/Province
Hessen
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Bonn Medizinische Klinik und Poliklinik III
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
Facility Name
Johanniter-Krankenhaus Rheinhausen GmbH Hämatologie / Internistische Onkologie / Tagesklinik
City
Duisburg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47228
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf Klinik für Hämatologie, Onkologie und Klinische Immunologie
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsklinikum Essen Klinik für Hämatologie
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Mühlenkreiskliniken Johannes Wesling Klinikum Minden Klinik für Hämatologie, Onkologie und Palliativmedizin
City
Minden
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32429
Country
Germany
Facility Name
Marienhospital
City
Düsseldorf
State/Province
North Rhine Westphalia
ZIP/Postal Code
40479
Country
Germany
Facility Name
Uniklinik RWTH Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitätsklinikum Magdeburg
City
Magdeburg
State/Province
Sachesen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH Klinik für Innere Medizin III
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09113
Country
Germany
Facility Name
Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Freiburg - Klinik für Innere Medizin I
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Onkologie, Hämatologie und KMT mit Sektion Pneumologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinik Jena - Klinik für Innere Medizin II
City
Jena
ZIP/Postal Code
07705
Country
Germany
Facility Name
Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik I
City
Leipzig
Country
Germany
Facility Name
UNIVERSITÄTSKLINIKUM Schleswig-Holstein - Klinik für Hämatologie und Onkologie, Campus Lübeck
City
Lübeck
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Ruxo-BEAT Trial in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia

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