EUCTR2014-003233-26-IT进行中（未招募）1 期
A Pivotal Multicenter Trial of Moxetumomab Pasudotox inRelapsed/Refractory Hairy Cell Leukemia - Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •Patients must have histologically confirmed hairy cell leukemia or hairy
- •cell leukemia variant .with a need for therapy based on at least one of
- •the following criteria:
- •neutrophils less than 1000/mm(3)
- •platelets less than 100,000/mm(3)
- •hemoglobin less than 10 g/dL)
- •symptomatic splenomegaly.
- •Patients must be Pseudomonas-immunotoxin naive
- •Patients must have had at least 2 prior purine analogs, or at least 1
- •course of purine analog and 1 of either rituximub or BRAF inhibitor.
- •Men or women age greater than or equal to 18 years. Because this
- •disease does not generally occur in children, children are excluded from
- •this study, but will be eligible for future pediatric trials in other indications.
- •ECOG performance status less than or equal to 2.
- •The effects of moxetumomab pasudotox on the developing human fetus
- •are unknown. For this reason, women of child-bearing potential and men
- •must agree to use adequate contraception (hormonal or barrier method
- •of birth control; abstinence) prior to study entry and for the duration of
- •study participation, and 4 months after completion of moxetumomab
- •pasudotox administration. Should a woman become pregnant or suspect
- •she is pregnant while she or her partner is participating in this study,
- •she should inform her treating physician immediately.
- •Patients must have adequate organ function as defined below:
- •total bilirubin less than or equal to 1.5 mg/dL, unless consistent with
- •Gilbert s (ratio between total and direct bilirubin greater than 5)
- •AST and ALT less than or equal to 3 times upper limit of normal (ULN)
- •alkaline phosphatase less than or equal to 2.5 ULN
- •serum creatinine less than or equal to 1.5 mg/dL or creatinine clearance
- •greater than or equal to 60 mL/min as estimated by the Cockcroft-Gault
- •Prothrombin time/INR or partial thromboplastin time less 2.5 ULN,
- •fibrinogen greater than or equal to 0.5 LLN; if on warfarin, INR less than
- •3.5, if on any other anticoagulation, PT less than 2.5 times baseline
- •Ability to understand and the willingness to sign a written informed
- •consent document.
- •Life expectancy greater than or equal to 6 months
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •Patients who have had chemotherapy, immunotherapy or radiotherapy
- •within 4 weeks prior to initiation of treatment.
- •Patients who are receiving any other investigational agents.
- •Patients with known brain metastases should be excluded from this
- •clinical trial because of their poor prognosis and because they often
- •develop progressive neurologic dysfunction that would confound the
- •evaluation of neurologic and other adverse events.
- •Patients with clinically significant ophthalmologic findings during
- •Pregnant or breastfeeding females. The effects of moxetumomab
- •pasudotox on the developing fetus are unknown. Because there is an
- •unknown but potential risk for adverse events in nursing infants
- •secondary to treatment of the mother with moxetumomab pasudotox
- •breastfeeding should be discontinued if the mother is treated with
- •moxetumomab pasudotox
- •Positive for Hepatitis B surface antigen unless the patient is on
- •Lamivudine or Entecavir and Hepatitis B Viral DNA load is less than 2000
- •Active second malignancy requiring treatment other than minor
- •resection of indolent cancers like basal cell and squamous skin cancers
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or
- •active infection, symptomatic congestive heart failure, unstable angina
- •pectoris, cardiac arrhythmia, malaria infection or psychiatric
- •illness/social situations that would limit compliance with study
- •requirements.
- •HIV-positive patients unless taking appropriate anti-HIV medications
- •with a CD4 count of greater than 200. Otherwise, there may be increased
- •risk of lethal infections when temporarily suppressing normal B-cells.
- •History of allogeneic bone marrow transplant.
- •Patients with history of both thromboembolism and known congenital
- •hypercoagulable conditions.
- •Uncontrolled pulmonary infection, pulmonary edema. Oxygen saturation at rest less than 88% measured by pulse oximetry or
- •PaO (2) less than or equal to 55 mm Hg.
- •Serum albumin less than 2 g/dL.
- •Radioimmunotherapy within 2 years prior to enrollment in study.
- •ANC less than 1000/mm(3), or platelet count less than 50,000/mm(3),
- •if these cytopenias are not judged by the investigator to be due to
- •underlying disease (ie, potentially reversible with antineoplastic
- •therapy). A patient will not be excluded because of pancytopenia greater
- •than or equal to Grade 3, or erythropoietin dependence, if it is due to
- •disease, based on the results of bone marrow studies.
- •Patients with less than 50% of predicted forced expiratory volume
- •(FEV1) or less than 50% of predicted diffusing capacity for carbon
- •monoxide (DLCO), corrected for hemoglobin concentration and alveolar
- •volume. Note: Patients with no prior history of pulmonary illness are not
- •required to have PFTs. FEV1 will be assessed after bronchodilator
- •Patients with history of thrombotic microangiopathy or TTP-HUS.
- •Patients with QTc elevation > grade 1
- •Patient on high dose estrogen (defined as > 0.625 mg/day of an
- •estrogen compound.
- •Patients with clinical evidence of disseminated intravascular coagulation (grade 3-4)
研究者
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