EUCTR2008-003016-35-ES进行中（未招募）不适用
Estudio Fase II de Panobinostat oral, en pacientes adultos con Linfoma de Hodgkin clásico refractario/en recaida, después de fallo a dosis altas de quimioterapia con transfusión autóloga de células madre y un régimen que contiene gemcitabina o vinorelbina o vinblastina
ovartis Farmacéutica S.A.0 个研究点目标入组 102 人开始时间: 2008年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
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. 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.
- •5. Patient has progressive disease on or after therapy with a
- •gemcitabine- or vinorelbine- or vinblastine-containing regimen, after
- •first relapse.
- •Note: If last therapy was more than ? 18 months ago, then a biopsy
- •should be performed to confirm diagnosis.
- •6. 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). See Posttext
- •supplement 1.
- •Note: Patients with bone marrow involvement are eligible, but this
- •criteria alone should not be used for disease measurement.
- •7. 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 10 9/L [SI units 1.5 x
- •? Platelet count ? 75 x 109/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 values must not be deemed to be a clinically significant
- •abnormality prior to patients being dosed.
- •? Serum creatinine ? 1.5 x ULN
- •? Serum bilirubin ? 1.5 x ULN (or ? 3.0 x ULN, if patient has Gilbert
- •? 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
- •8. Clinically euthyroid
- •Note: Patients are permitted to receive thyroid hormone supplements
- •to treat underlying hypothyroidism.
- •9. Written informed consent was obtained from the patient prior to any
- •study-specific screening procedures
- •10. 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 has been treated with allogeneic hematopoietic stem cell
- •transplant who 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 >100
- •bpm). 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
- •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
- 另有 9 项未显示
研究者
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