EUCTR2008-003016-35-GB进行中（未招募）1 期
A Phase II Study of Oral Panobinostat in adult patients with Relapsed/Refractory classical Hodgkin’s Lymphoma after High-dose Chemotherapy with Autologous Stem Cell transplant.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 129
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
入选标准
- •1. Patient age is = 18 years
- •2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of = 2
- •3. Patient has a history of classical HL (i.e. Nodular sclerosing, Mixedcellularity, Lymphocyte-rich, Lymphocyte depleted)
- •4. Patient has progressive disease after receiving high dose chemotherapy with AHSCT.
- •Note: If last therapy was more than = 18 months ago, then a biopsy
- •should be performed to confirm diagnosis.
- •Note: Patient should have received <= 5 prior systemic treatment regimens (see PTS 2)
- •5. Patient has at least one site of measurable nodal disease at baseline = 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. (MRI is allowed only if CT scan can not be performed).
- •Note: Patients with bone marrow involvement are eligible, but this
- •criterion alone should not be used for disease measurement.
- •6. Patient has the following laboratory values (labs may be repeated, if needed, to obtain acceptable values before screen fail):
- •Absolute neutrophil count (ANC) = 1.5 x 10exp9/L [SI units 1.5 x10exp9/L]
- •Platelet count = 75 x 10exp9/L
- •Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution
- •Note: Potassium, calcium, magnesium, sodium, and/or phosphorus supplements may be given to correct values that are • Serum creatinine = 1.5 x ULN
- •Serum bilirubin = 1.5 x ULN (or = 3.0 x ULN, if patient has Gilbert syndrome)
- •AST/SGOT and/or ALT/SGPT = 2.5 x upper limit of normal (ULN) or = 5.0 x ULN if the transaminase elevation is due to disease involvement
- •7. Clinically euthyroid
- •Note: Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.
- •8. Written informed consent was obtained from the patient prior to any study-specific screening procedures
- •9. Patient has the ability to swallow capsules or tablets
- •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. Patient has a history of prior treatment with a DAC inhibitor including panobinostat
- •2. Patient will need valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat treatment
- •3. Patient has been treated with monoclonal antibody therapy (e.g.,rituximab or anti CD-30 antibody, etc.) within 4 weeks of start of study treatment
- •4. Patient has received chemotherapy or any investigational drug or undergone major surgery = 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to = grade 1
- •5. Patient has been treated with > 5 prior systemic lines of treatment (see Post-text supplement 2 for definitions and examples)
- •6. Patient has received prior radiation therapy = 4 weeks or limited field radiotherapy = 2 weeks prior to start of study treatment or whose side effects of such therapy have not resolved to = grade 1
- •7. Patient is using any anti-cancer therapy concomitantly
- •8. Patient treated with allogeneic hematopoietic stem cell transplant who is currently on or has received immunosuppressive therapy within 90 days prior to start of screening and/or have = Grade 2 graft versus host disease (GvHD).
- •9. Patient has a history of another primary malignancy = 3 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
- •10. Patient has a history of CNS involvement with lymphoma
- •11. Patient has impaired cardiac function including any of the following:
- •Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute), QTcF > 450 msec on
- •screening ECG, or right bundle branch block + left anterior hemiblock (bifascicular block)
- •Presence of unstable atrial fibrillation (ventricular heart rate >100bpm). Patients with stable atrial fibrillation are allowed in the study provided they do not meet the other cardiac exclusion criteria
- •Previous history angina pectoris or acute MI within 6 months
- •Congestive heart failure (New York Heart Association functional classification III-IV)
- •12. Patient has any other clinically significant heart disease (e.g.,uncontrolled hypertension)
- •13. Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
- •14. Patient has unresolved diarrhea = grade 2
- •15. Patient has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest from any cause) that could cause unacceptable safety risks or compromise compliance
- •with the protocol
- •16. Patient has a known history of HIV seropositivity (screening HIV testing is not required)
- •17. Patient is using medications that have a re
研究者
相似试验
进行中（未招募）
不适用
Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkin's LymphomaRelapsed/refractory classical Hodgkin's lymphomaMedDRA version: 14.1Level: PTClassification code 10020206Term: Hodgkin's diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-003016-35-DEovartis Pharma Services AG102
进行中（未招募）
1 期
A phase II study of oral Panobinostat in adult patients with relapsed/refractory diffuse large B-cell lymphoma after high-dose chemotherapy with autologous stem cell transfusion (ASCT) or in adult patients who are not eligible for ASCT - FIL_PanAL10Patient has a history of DLBCL according to the WHO classification. with progressive disease after receiving at least CHOP-R or CHOP-R like first line regimen and is not considered eligible for intensiveMedDRA version: 13.1Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2011-000175-13-ITFONDAZIONE ITALIANA LINFOMI ONLUS35
进行中（未招募）
1 期
A Phase II Study of Oral Panobinostat in Adult Patients withRelapsed/Refractory Classical Hodgkin’s Lymphoma after high-dose chemotherapy with autologous stem cell transplantrelapsed/refractory classical Hodgkin's lymphomaMedDRA version: 13.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-003016-35-BEovartis Pharma Services AG102
进行中（未招募）
不适用
A Phase II Study of Oral Panobinostat in Adult Patients with Relapsed/Refractory Classical Hodgkin?s Lymphoma after Failure of High-dose Chemotherapy with Autologous Stem Cell Transfusion and a Gemcitabine- or Vinorelbine- or Vinblastine-Containing Treatment Regimen - NDRelapsed/Refractory Classical Hodgkin?s LymphomaMedDRA version: 9.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaEUCTR2008-003016-35-ITOVARTIS FARMA102
进行中（未招募）
不适用
A Phase II Study of Oral Panobinostat in Adult Patients with Relapsed/Refractory Classical Hodgkin’s Lymphoma after Failure of High-dose Chemotherapy with Autologous Stem Cell Transfusion and a Gemcitabine- or Vinorelbine- or Vinblastine-Containing Treatment Regimen.relapsed/refractory classical Hodgkin's lymphomaMedDRA version: 9.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaEUCTR2008-003016-35-FRovartis Pharma Services AG102