NCT03501615Approved For Marketing不适用
An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 发起方
- AstraZeneca
研究概览
简要总结
Early Access Programme to provide treatment access to moxetumomab pasudotox for eligible patients with relapsed/refractory hairy cell leukemia
详细描述
Multicentre Early Access Programme, designed to provide treatment access to moxetumomab pasudotox for eligible patients with relapsed/refractory hairy cell leukemia who are at least 18 years of age, have adequate organ function and are Pseudomonas-immunotoxin naïve. Patients will be administered moxetumomab pasudotox on Days 1, 3 and 5 of each 28-day cycle until documentation of CR or for up to 6 cycles, progressive disease (PD), initiation of alternate therapy or unacceptable toxicity.
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed HCL or HCL variant with a need for therapy based on at least one of the following criteria:
- •a neutrophils < 1.0x 109/L b platelets < 100 x 109/L c hemoglobin < 10 g/dL d symptomatic splenomegaly
- •Pseudomonas-immunotoxin naïve
- •At least 2 prior systemic therapies, including 2 courses of a PNA, or 1 course of either rituximab or BRAF inhibitor following a single prior course of PNA.
- •Age ≥ 18 years.
- •ECOG performance status ≤ 2
- •Adequate organ function as defined below:
- •total bilirubin ≤ 1.5 mg/dL, unless consistent with Gilbert's (ratio between total and direct bilirubin > 5)
- •AST and ALT ≤ 3x upper limit of normal (ULN)
- •alkaline phosphatase < 2.5 ULN
- •serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min as estimated by the Cockcroft-Gault equation
- •Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) < 2.5 ULN, fibrinogen ≥ 0.5 lower limit of normal; if on warfarin, INR < 3.5, if on any other anticoagulation, PT < 2.5 x baseline
- •Ability to understand and the willingness to sign a written informed consent document.
- •Life expectancy ≥ 6 months.
- •Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception prior to study entry and for the duration of study participation, and must agree to continue using such precautions for 4 months after completion of moxetumomab pasudotox administration; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
排除标准
- •Have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to initiation of treatment.
- •Receiving any other investigational agents.
- •Known brain metastases
- •Retinal or choroidal detachment identified during the screening ophthalmologic evaluation.
- •Pregnant or breastfeeding females. .
- •Positive for Hepatitis B core antibody or surface antigen unless the patient is on Lamivudine or Entecavir and Hepatitis B Viral deoxyribonucleic acid (DNA) load is < 2000 IU/mL.
- •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, uncontrolled hypertension, cardiac arrhythmia, malaria infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Known human immunodeficiency virus (HIV)-positive patients unless taking appropriate anti-HIV medications with a CD4 count of >
- •10.History of allogeneic bone marrow transplant. 11.History of both thromboembolism and known congenital hypercoagulable conditions. 12.Uncontrolled pulmonary infection, pulmonary edema 13.Oxygen saturation at rest < 88% measured by pulse oximetry or PaO2
- •55 mm Hg 14.Serum albumin < 2 g/dL 15.Radioimmunotherapy within 2 years prior to enrollment in the study. 16.Absolute neutrophil count (ANC) < 1.0 x 109/L, or platelet count < 50 x 109/L, unless judged by the investigator to be due to underlying disease A patient will not be excluded because of pancytopenia ≥ Grade 3, or erythropoietin dependence, if due to disease, based on the results of bone marrow studies. 17.Patients with < 50% of predicted forced expiratory volume or < 50% of predicted diffusing capacity for carbon monoxide, corrected for hemoglobin concentration and alveolar volume 18.History of thrombotic microangiopathy or thrombotic microangiopathy / HUS. 19.Corrected QT interval (Frederica) elevation > 500 msec (manually over-read by medically qualified person) based on at least two separate 12-lead ECGs. 20.High dose estrogen (defined as > 0.625 mg/day of an estrogen compound). 21.Clinical evidence of disseminated intravascular coagulation (Grade 3- 4).
研究者
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