EUCTR2006-002011-27-DK进行中（未招募）不适用
A phase II, multicentre study of oral LBH589 in patients with accelerated phase or blast phase (blast crisis) chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 71
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+ accelerated or blast phase CML defined as:
- •Accelerated phase - the presence of at least one of the following:
- •- =15% but <30% blasts in blood or bone marrow
- •- =30% blasts plus promyelocytes in peripheral blood or bone marrow (providing that <30% blasts present in bone marrow)
- •- = 20% basophiles in the peripheral blood
- •- Thrombocytopenia <100 X 109 /L unrelated to therapy
- •Blast phase (blast crisis) - the presence of one of the following:
- •- = 30% blasts in the blood, marrow or both
- •- Extramedullary infiltrates of leukemic cells
- •Prior treatment with at least two BCR-ABL tyrosine kinase inhibitors (i.e., imatinib, nilotinib, or dasatinib) and demonstrated resistance to the most recent 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:
- •- A patient who was in chronic phase CML who had disease progression to either accelerate phase or blast crisis
- •- A patient who was in accelerated phase had disease progression to blast crisis
- •- Patients in AP or BC who did not achieve a hematologic response (defined as not achieving CHR, NEL or RTC) within 3 months of starting therapy
- •- Patients in AP or BC who had increasing blast counts in peripheral blood or increasing marrow leukemic infiltrate (MLI, the percent marrow blasts multiplied by marrow cellularity)
- •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 their most recent BCR-ABL kinase inhibitor as defined above.
- •Patients must meet special laboratory criteria (details 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 who are in chronic phase (CP) 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 IV)
- •- 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 (other than BCR-ABL tyrosine kinase inhibitors) 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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