EUCTR2008-003016-35-BE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 transplant
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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.
- •Note: If last therapy was = 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 for definitions and examples)
- •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
- •criteria 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 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
- •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 has been treated with allogeneic hematopoietic stem cell
- •transplant who isq 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 >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
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研究者
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