EUCTR2012-005629-65-GB进行中（未招募）1 期
Management of Transformed Chronic myeloid leukaemia: Ponatinib and Intensive chemotherapy: a dose finding study - Matchpoint
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- •All of the following:
- •Ph-positive or BCR-ABL positive CML in blastic transformation. Defined as one or more of the following being present:
- •oBlasts =30% in peripheral blood or bone marrow
- •oExtramedullary blast proliferation or large foci or clusters of blasts in the bone marrow biopsy
- •Suitable for intensive chemotherapy (FLAG-IDA)
- •Adequate renal function defined as serum creatinine =1.5 X upper limit of normal (ULN)
- •Adequate liver function defined as:
- •oTotal bilirubin < 1.5 X ULN, unless due to Gilbert’s syndrome
- •oAlanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 X ULN (< 5 X ULN if liver involvement with leukaemia. Patients with disordered liver function >5 X ULN due to leukaemia may enter with a dose reduction of FLAG-IDA as per local guidelines and will be considered on a per patient basis following discussion with the Chief Investigator and Trial Office.)
- •Normal pancreatic status defined as:
- •oSerum Amylase = 1.5 X ULN
- •Normal QTcF interval on screening ECG evaluation, defined as QTcF of = 450 ms in males or =470 ms in females.
- •Female and male patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners throughout participation in this study until 4 months after the last dose of ponatinib.
- •Ability to comply with study procedures, in the Investigator’s opinion.
- •Valid Informed Consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Any of the following will exclude:
- •Received chemotherapy other than hydroxycarbamide, anagrelide, low dose arabinosylcytarabine (LDAC), steroids, or interferon within 4 weeks of registration
- •Changed TKI therapy more than once since confirmation of blast phase CML or had prior treatment with ponatinib at any time.
- •Previous treatment with intensive acute leukaemia-style chemotherapy (FLAG-IDA). (Unless treatment was during an initial blast phase which returned to chronic phase for a prolonged period of time and the patient is now in a second blast phase.)
- •Prior allogeneic or autologous Stem Cell Transplant
- •Significant or active cardiovascular disease, specifically including but not restricted to:
- •oMyocardial infarction, stroke or revascularization within 12 months prior to registration
- •oHistory of clinically significant atrial arrhythmia
- •oAny history of or ventricular arryhthmia
- •oUnstable angina or transient ischemic attack within 6 months prior to registration
- •oCongestive heart failure within 6 months prior to registration
- •oLeft ventricular ejection fraction (LVEF) less than lower limit of normal within 6 months prior to registration
- •oAny history of unprovoked venous thromboembolism including deep venous thrombosis or pulmonary embolism
- •oUncontrolled hypertension (sustained diastolic blood pressure >90 mm Hg; systolic >140 mm Hg).
- •History of acute pancreatitis within 1 year prior to registration
- •History of chronic pancreatitis.
- •Uncontrolled hypertriglyceridaemia (>450 mg/dL)
- •Are pregnant or lactating
- •Are known galactose intolerant
- •Underwent major surgery (with the exception of minor surgical procedures, such as catheter placement or Bone Marrow biopsy) within 14 days prior to registration
- •Suffer from any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the safety of the study treatment
研究者
相似试验
已完成
1 期
Management of Transformed Chronic myeloid leukaemia: Ponatinib and Intensive chemotherapyTopic: National Cancer Research NetworkSubtopic: Haematological OncologyDisease: Leukaemia (chronic)Chronic myeloid leukaemia [CML], BCR/ABL-positiveCancerISRCTN98986889niversity of Birmingham (UK)17
招募中
2 期
Efficacy of assigning treatment for participants with Chronic Myelomonocytic Leukaemia based on their individual molecular results (lenzilumab plus azacitidine versus sodium ascorbate plus azacitidine).Chronic Myelomonocytic LeukaemiaCancer - Leukaemia - Chronic leukaemiaACTRN12621000223831South Australian Health & Medical Research Institute Ltd72
进行中（未招募）
不适用
TREATMENT OF PRIMARY ACUTE MYELOID LEUKEMIA WITH THE COMBINATION OF IDARUBICIN, CYTARABINE AND GEMTUZUMAB OZOGAMYCIN (MYLOTARG) ASSOCIATED OR NOT TO G-CSF PRIMING: PROSPECTIVE STUDY OF EFFICACY AND TOXICITY.Tratamiento de la leucemia mieloide aguda de novo con la combinación de idarrubicina, citarabina y gemtuzumab ozogamicina (Mylotarg), asociada o no a priming con G-CSF. Estudio prospectivo de eficacia y toxicidad. - Farmacoterapia de inducción con Mylotarg en LMAeucemia Mieloide Aguda Primaria de novoMedDRA version: 9.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaEUCTR2007-006295-11-ESInstituto de Investigación del Hospital de la Santa Creu i Sant Pau
已完成
不适用
CML V - chronic phase Chronic Myeloid LeukaemiaeukaemiaMyeloid leukaemiaCancerISRCTN68784584niversity of Oxford (UK)800
进行中（未招募）
1 期
Treatment of blood cancer with the use of a drug active against herpesvirusesChronic lymphocytic leukemiaMedDRA version: 14.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-021786-78-ATMedizinische Universität Wien