JAK2 Mutasyonlu Miyeloproliferatif Neoplazm Hastalarında Sempatomimetik Agonist

Sade dilde özet

Bu çalışma, Mirabegron adlı ilacın JAK2 mutasyonu taşıyan miyeloproliferatif neoplazm (myeloproliferative neoplasms) hastalarındaki etkisini incelemiştir. Çalışmaya, kanında JAK2-V617F mutasyonu doğrulanmış ve belirli bir mutasyon yükü bulunan, 18 yaş ve üzeri hastalar dahil edilmiştir. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Swiss Cancer Institute

Müdahale

Mirabegron

Başlangıç

01.04.2015

Tahmini bitiş

01.12.2016

Ülkeler

Switzerland

İlgili genler

Merkezler

• Aarau, Switzerland
• Basel, Switzerland
• Bellinzona, Switzerland
• Bern, Switzerland
• Geneva, Switzerland
• Lausanne, Switzerland
• Liestal, Switzerland
• Lucerne, Switzerland
• Münsterlingen, Switzerland
• Zurich, Switzerland
• Zurich, Switzerland

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* 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 Criteria:

* 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.