EUCTR2006-000881-35-GB进行中（未招募）不适用
A phase II, multicentre study of oral LBH589 in patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Male or female patients aged = 18 years old
- •Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- •Diagnosis of Ph+ chronic phase CML (details see study protocol)
- •No evidence of extramedullary leukemic involvement, with the exception of liver or spleen
- •Prior treatment with at least two BCR-ABL tyrosine kinase inhibitors (i.e. imitinib, nilotinib, or dasatinib) and demonstrates resistance to the kinase inhibitor therapy.
- •Resistance to a tyrosine kinase inhibitor for eligibility into this protocol is defined as one of the following while the patient was on therapy:
- •1. Primary hematologic resistance:
- •Patients who do not achieve a CHR within 6 months of starting therapy.
- •Patients who did not achieve a CHR at any time and whose disease progressed on therapy as defined by a doubling of the count to a value of more than 20,000 per cubic
- •2. Acquired hematologic resistance i.e., the loss of complete hematologic response (defined as the appearance of any of the following in two blood samples obtained at least 2 weeks apart: a white-cell count of more than 20,000 per cubic millimeter, a platelet count of at least 600,000 per cubic millimeter, the appearance of extramedullary disease, the appearance of at least 5 percent myelocytes and metamyelocytes in the peripheral blood, or the appearance of blasts or promyelocytes in the peripheral blood)
- •3. Acquired cytogenetic resistance defined i.e., the loss of major cytogenetic response (defined as an increase in Ph+ positive cells in metaphase by at least 30 %)
- •Patients with a history of intolerance to one BCR-ABL kinase inhibitors (defined as discontinuation of treatment due grade 3 or 4 adverse events related to treatment) will be considered eligible to enter the study if they demonstrate resistance to one other BCR-ABL kinase inhibitor as defined above.
- •Patients who are intolerant of at least 2 BCR-ABL kinase inhibitors will be considered eligible to enter this study if they also demonstrate resistance to or intolerance of interferon-alpha (IFN-a) by the same criteria defined above.
- •Patients must meet special laboratory criteria (see protocol)
- •Baseline MUGA or ECHO must demonstrate LVEF = the lower limit of the institutional normal
- •Patients with an ECOG Performance Status of = 2
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A candidate for hematopoitic stem cell transplantation (HSCT) (i.e. patient is a candidate, has an appropriate donor, and agrees to transplantation)
- •Prior treatment with an HDAC inhibitor
- •Patients with a prior history of accelerated phase or blast crisis CML
- •Impaired cardiac function including any one of the following:
- •- Screening ECG with a QTc > 450 msec
- •- Patients with congenital long QT syndrome
- •- History of sustained ventricular tachycardia
- •- Any history of ventricular fibrillation or torsades de pointes
- •- Bradycardia defined as HR < 50 beats per minute (patients with a history of bradycardia who now have a permanent pacemaker and HR = 50 bpm are eligible)
- •- Patients with a myocardial infarction or unstable angina within 6 months of study entry
- •- Congestive heart failure (NY Heart Association class III or i.v)
- •- Right bundle branch block and left anterior hemiblock (bifasicular block)
- •- Uncontrolled hypertension
- •Concomitant use of drugs with a risk of possible risk of causing QTc prolongation or torsades de pointes listed in Post-text Supplement 1
- •Concomitant use of CYP3A4 inhibitors listed in Post-text Supplement 1
- •Concomitant use of any other anti-cancer therapy except anegrilide or hydroxyurea (see Section 6.6.7)
- •Patients with unresolved diarrhea ?CTCAE grade 1
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
- •Patients who have received chemotherapy, any investigational drugs or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- •Patients who have received a BCR-ABL tyrosine-kinase inhibitor within 1 week of first treatment with LBH589
- •Female patients who are pregnant or breast feeding or patients of reproductive potential not using an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first administration of oral LBH589
- •Male patients whose sexual partners are WOCBP not using effective birth control
研究者
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