Status:
COMPLETED
Sympathicomimetic Agonist in Patients With Myeloproliferative Neoplasms With JAK2-mutation
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Myeloproliferative Neoplasm
Primary Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this phase II study is to test a novel concept in the treatment of patients with myeloproliferative neoplasms (MPN), a disease of the bone marrow. With no current cure available, MPN are a ...
Detailed Description
DISEASE BACKGROUND Myeloproliferative neoplasms (MPN) are clonal stem cell disorders characterized by aberrant proliferation of the erythroid, megakaryocytic and myeloid lineages. They are associated...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of JAK2-V617F positive ET, PV or PMF at primary diagnosis or pretreated
- JAK2-V617F mutant allele burden \> 20% in the peripheral blood at study entry
- Patient must give written informed consent before registration
- WHO performance status 0-2
- Age ≥ 18 years
- Adequate hematological values: neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/ L
- Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT/AP ≤ 2.5 x ULN
- Adequate renal function (calculated creatinine clearance \> 50 mL/min, according to the formula of Cockcroft-Gault)
- Women are not breastfeeding. Women with child-bearing potential are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during 28 days thereafter. A negative pregnancy test before inclusion (within 7 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during participation in the trial and during 28 days thereafter.
- Patient compliance and geographic proximity allow proper staging and follow-up.
Exclusion
- Leukemic transformation (\>20% blasts in blood, marrow or extramedullary site)
- Diabetic neuropathy
- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, known cardiac rhythm disturbance including atrial fibrillation or QT prolongation
- Uncontrolled hypertension
- Treatment of ET, PV or PMF with IFNα or treatment of PMF with JAK inhibitors such as ruxolitinib within 3 months prior to trial entry.
- Previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
- Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent or interfering with compliance for oral drug intake.
- Treatment with hematopoietic stem cell transplantation
- Concurrent treatment with cytoreductive drugs, other experimental drugs or other anti-cancer therapy as well as treatment in a clinical trial within 2 months prior to trial entry.
- Any serious underlying medical condition (at the judgment of the investigator), which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes, uncontrolled infection (HIV, Hepatitis B and C).
- Known hypersensitivity to trial drug or hypersensitivity to any other component of the trial drug.
- Any concomitant drugs contraindicated for use with the trial drug according to the approved product information.
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02311569
Start Date
April 1 2015
End Date
December 1 2016
Last Update
May 15 2019
Active Locations (11)
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1
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
2
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
3
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
4
Inselspital Bern
Bern, Switzerland, CH-3010