EUCTR2016-000618-30-DE进行中（未招募）1 期
Phase 2 Clinical Trial with Ponatinib as a Second Line Therapy for Patients with Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to prior First Line Tyrosine Kinase Inhibitor Treatment - PONS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GWT-TUD GmbH
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female patients =18 years old
- •2. Diagnosis of Ph-positive (by cytogenetics) or BCR-ABL-positive (by PCR) CP-CML
- •3. Patients should have demonstrated to have:
- •Either a failure of a prior 1st line TKI treatment*,** with either imatinib, dasatinib or nilotinib. A failure is defined as per European LeukemiaNet (ELN) recommendations:
- •o Less than CHR and/or Ph+ > 95% at or beyond 3 months
- •o No cytogenetic response (Ph+>35%) and/or BCR-ABL1 >10% at or beyond 6 months
- •o BCR-ABL (on international scale) >1% and/or Ph+ >0% at or beyond 12 months
- •o Less than MMR at or beyond 18 months
- •o Loss of response or development of mutations or other clonal chromosomal abnormalities at any time during the first line TKI treatment
- •or an intolerance to prior TKI treatment* (TKI related intolerance) defined as grade 3 or 4 toxicity, or persistent grade 2 toxicity despite optimal management including dose adjustment, or in a patient where dose reductions are considered to be not in the patient’s best interest to obtain an adequate response. At time of enrollment intolerant patients should:
- •have lost major molecular response -or-
- •not have achieved or have lost major molecular response
- •(*) Patients with intolerance/failure to TKI combination therapy with Asciminib or PEG-IFN could be considered as eligible after consolidation with CPI.)
- •(**) Patients that received TKI as medical treatment for CML for no longer than 2 weeks duration prior to First Line TKI therapy are categorized as First Line regimen.)
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •5. Adequate hepatic function as defined by the following criteria:
- •Total serum bilirubin =1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome, in which case it should be = 3.0xULN)
- •6. Adequate renal function as defined by the following criterion:
- •Creatinine clearance of = 50 mL/min
- •7. Adequate pancreatic function as defined by the following criterion:
- •Serum lipase and amylase =1.5×ULN
- •8. For patients of childbearing potential, a negative pregnancy test must be documented prior to enrollment. Postmenopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential
- •9. Female and male patients who are fertile must agree to use effective forms of contraception with their sexual partners from signing off the informed consent form for this study until 3 months after the end of treatment
- •10. Provision of written informed consent and specifically the consent to the collection and processing of health-related data
- •11. Willingness and ability to comply with scheduled visits and study procedures
- •12. Patients should have discontinued therapy with prior TKI (except hydroxyurea), at least 48 hours prior to start of study therapy
- •13. Fully recovered from the acute effects of prior cancer therapy before initiation of study drug
- •14. Patients must have had an eye examination confirming no objectives towards study participation by the ophthalmologist within 8 weeks prior to first treatment. . It is recommended to use Ophthalmoscopy to perform the eye examination (additional tests may be used as clinically indicated or as per physician discretion).The eye examinations should test the retinal vasculature
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this ag
排除标准
- •1. Any 1st line anti-CML treatment other than TK (apart from therapy with hydroxyurea)
- •2. Any 2nd line therapy with a tyrosine kinase inhibitor (>1 EMA approved TKI for CML, or any investigational non EMA-approved TKI)
- •3. Concurrent participation in any other clinical trial involving another investigational drug*** within 4 weeks prior to enrollment and throughout participation in PONS-Study
- •(*** relates to participation during treatment phase/ investigational drug application phase)
- •4. NYHA cardiac class 3-4 heart disease
- •5. Cardiac Symptoms within the past 12 months prior recruitment: Patients meeting the following criteria are not eligible:
- •History of unstable angina, myocardial infarction, TIA, stroke, peripheral arterial occlusive disease or pulmonary embolism
- •Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- •Prolonged QTc interval on pre-entry electrocardiogram (> 450 ms in men, > 470 ms in women) on the Fridericia correction formula
- •Congestive heart failure (NYHA Class III or IV) within 3 months prior to first dose of ponatinib
- •6. Patients with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders
- •7. Patients with uncontrolled hypertension (defined as sustained systolic blood pressure > 140 mmHg or diastolic > 90 mmHg)
- •8. Pregnant or breast-feeding women are excluded
- •9. Patients with history of pancreatitis
- •10. Patients in accelerated or blast phase, or patients who have ever been documented to be in blast phase CML, are excluded. The definitions of excluded CML phases are as follows:
- •Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow
- •Accelerated phase CML: presence of any of the following features:
- •o Peripheral or marrow blasts 15% or more
- •o Peripheral or marrow basophils 20% or more
- •o Thrombocytopenia < 100 x 10^9/L unrelated to therapy
- •o Documented extramedullary blastic disease outside liver or spleen
- •Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome has historically been included as a criterion for accelerated phase. However, patients with clonal evolution as the only criterion of accelerated phase have a significantly better prognosis. Thus, patients with clonal evolution and no other criteria for accelerated phase will be eligible for this study, but analyzed separately
- •11. Patients showing an intolerance to the active substance or to any of the other ingredients of the test drug
- •12.Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- •13.Patients who may be dependent on the sponsor, trial site or investigator
- •14. Patients with active SARS-CoV-2 infection
研究者
相似试验
进行中（未招募）
1 期
Ensayo clínico pivotal en fase II de ponatinib (AP24534) en pacientes con leucemia mieloide crónica refractaria y leucemia linfoblástica aguda con Ph+ / A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients with Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic LeukemiaEUCTR2010-020414-28-ESARIAD Pharmaceuticals, Inc.350
进行中（未招募）
1 期
ot applicablePatients with Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic LeukemiaMedDRA version: 17.0Level: LLTClassification code 10024329Term: LeukemiaSystem Organ Class: 100000004864EUCTR2010-020414-28-SEARIAD Pharmaceuticals, Inc.449
已完成
2 期
A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients with Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia10024324Bloodcancerbone marrow cancerNL-OMON39645ARIAD Pharmaceuticals, Inc.10
进行中（未招募）
1 期
ot applicableEUCTR2010-020414-28-GBARIAD Pharmaceuticals, Inc.449
进行中（未招募）
1 期
A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients with Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic LeukemiaEUCTR2010-020414-28-FRARIAD Pharmaceuticals, Inc.350