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临床试验/EUCTR2007-001396-11-DE
EUCTR2007-001396-11-DE进行中（未招募）不适用

A Phase II Clinical Trial of PXD101 in Patients with Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

TopoTarget A/S0 个研究点目标入组 68 人开始时间: 2007年5月21日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
68
研究概览入排标准研究者记录与标识符相似试验

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. Adequate bone marrow and hepatic function including the following:
  • •a. Absolute neutrophil count = 1,000 cells/mm3, platelets
  • •= 40,000/mm3
  • •b. Total bilirubin =1.5 x upper normal limitor =3 x upper limit if documented hepatic involvement with lymphoma
  • •c. AST (SGOT) and ALT (SGPT) =2.5 x upper normal limit (=5 x upper normal limit if documented hepatic involvement with lymphoma.
  • •6. Serum potassium within normal range.
  • •7. Karnofsky performance status > 70%.
  • •8. Estimated life expectancy greater than 3 months.
  • •9. 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
  • •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. Adequate bone marrow and hepatic function including the following:
  • •a. Absolute neutrophil count = 1,000 cells/mm3, platelets
  • •= 40,000/mm3
  • •b. Total bilirubin =1.5 x upper normal limitor =3 x upper limit if documented hepatic involvement with lymphoma
  • •c. AST (SGOT) and ALT (SGPT) =2.5 x upper normal limit (=5 x upper normal limit if documented hepatic involvement with lymphoma.
  • •6. Serum potassium within normal range.
  • •7. Karnofsky performance status > 70%.
  • •8. Estimated life expectancy greater than 3 months.
  • •9. 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, history of sustained ventricular tachycardia, history of ventricular fibrillation or Torsade de Pointes, bradycardia (HR<50bpm) with or without a pacemaker, bifascicular block with a right bundle branch block and a left anterior block, 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 >450 msec; Long QT Syndrome; the required use of concomitant
  • •medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix A for a list).
  • •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. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year)when used consistenrly and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.) 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.
  • •15. For study centers in France, patients that are not affiliated with social security (France only).
  • •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, history of sustained ventricular tachycardia, history of ventricular fibrillation or Torsade de Pointes, bradycardia (HR<50bpm) with or without a pacemaker, bifascicular block with a right bundle branch block and a left anterior block, 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 >450 msec; Long QT Syndrome; the required use of concomitant
  • 另有 14 项未显示

研究者

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