EUCTR2007-001396-11-FR进行中（未招募）1 期
A Phase II Clinical Trial of PXD101 in Patients with Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
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
- •1. Male or female with age = 18 years.
- •2. A histologically confirmed diagnosis of CTCL or PTCL or other T-cell NHL(WHO/Revised European-American Lymphoma classification). ALCL patients
- •presenting with CD30+, alk-, and no extracutaneous involvement (i.e. confirmed
- •absence of systemic disease) will be enrolled in the CTCL arm
- •3. Patients must have failed at least one line of prior systemic therapy, and there is no limitation in number of prior therapies. For CTCL, patients who are refractory or
- •intolerant to oral Targretin are also eligible.
- •4. The presence of measurable disease (defined as = 1 cm with radiographic imaging) for PTCL or stage 1B or greater disease for CTCL and assessable by the severityweighted assessment tool (SWAT).
- •5. Patients must have had a chest x-ray, CT scan or CT/PET scan or SWAT assessment within 2 weeks prior to enrollment for CTCL patients or within 4 weeks prior to enrollment for PTCL patients and after completion of any prior cytotoxic
- •chemotherapy. Patients with a history of bone marrow involvement must have a bone marrow biopsy within 4 weeks of study enrollment.
- •6. Adequate bone marrow and hepatic function including the following:
- •a. WBC = 3,000 cells/mm3, absolute neutrophil count = 1,500 cells/mm3, platelets
- •= 50,000/mm3
- •b. Total bilirubin =1.5 x upper normal limit.
- •c. AST (SGOT), ALT (SGPT) and alkaline phosphatase =2.5 x upper normal limit
- •d. Hemoglobin = 9.0 g/dL.
- •7. Serum potassium within normal range.
- •8. Karnofsky performance status > 70%.
- •9. Estimated life expectancy greater than 3 months.
- •10. Signed informed consent approved by the Institutional Review Board.
- •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
- •1. Patients who have received anticancer therapies within 4 weeks of first PXD101
- •administration should be excluded unless toxicity from prior anticancer therapy has
- •resolved or returned to baseline and cancer disease status warrants. The exception is patients who have received alemtuzumab; these patients are excluded if they have received alemtuzumab within one year of first PXD101 administration.
- •2. Any use of investigational drugs within 4 weeks prior to study registration.
- •3. Major surgery within 4 weeks of study drug administration.
- •4. Prior allogenic bone marrow transplant.
- •5. A diagnosis of Adult T-cell lymphoma/leukemia (ATLL) or Precursor Tlymphoblastic
- •6. Co-existing active infection or any co-existing medical condition likely to interfere
- •with trial procedures. However, patients with progressing CTCL whose open skin
- •lesions are frequently infected may not be excluded from this trial at the discretion of
- •Investigators.
- •7. Clinically significant cardiovascular disease including unstable angina pectoris,
- •uncontrolled hypertension, and congestive heart failure related to primary cardiac
- •disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular
- •heart disease, a myocardial infarction within 6 months or a Left Ventricular Ejection
- •Fraction (LVEF) < 40% (by Echocardiogram (ECHO) or Multiple Gated Acquisition
- •Scan (MUGA)) within 3 months of study enrollment.
- •8. A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >500 msec; Long QT Syndrome; the required use of concomitant
- •medication on PXD101 infusion days that may cause Torsade de Pointes.
- •9. Patients with renal insufficiency defined as a calculated creatinine clearance of <45
- •mL/min/1.73 m2 based on Cockroft and Gault’s method (Cockroft 1976) or an
- •alternative calculation method used locally.
- •10. Patients with a history of allergic reactions attributed to compounds of similar
- •chemical or biological composition to PXD101 and L-arginine.
- •11. Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process
- •and/or completion of the necessary studies.
- •12. Other malignant diseases requiring treatment and patients who are less than 5 years post-treatment completion for an invasive malignant disease (except for nonmelanotic skin cancers or cervical cancer in-situ.) Patients with any history of
- •melanoma should be excluded.
- •13. Pregnant or breast-feeding women and women of childbearing age and potential,
- •who are not willing to use effective contraception. Male patients and/or their fertile
- •female partners who are not willing to use contraceptives during the trial.
- •14. Known active infection with HIV, HTLV-1, hepatitis B or hepatitis C.
研究者
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