EUCTR2011-000175-13-IT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_PanAL10
FONDAZIONE ITALIANA LINFOMI ONLUS0 个研究点目标入组 35 人开始时间: 2011年5月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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 DLBCL according to the WHO classification 4. Patient has progressive disease after receiving at least CHOP-R or CHOP-R like first line regimen, standard second line therapy (DHAP, ESHAP, ICE or similar salvage regimens) inclusive ASCT 5. Patient has progressive disease after receiving at least CHOP-R or CHOP-R like first line regimen and is not considered eligible for intensive salvage therapy including ASCT because of age, co-morbidities, impossibility to perform ASCT 6. Patient undergoes at baseline new lymphnode or other pathologic tissue biopsy for confirmation of diagnosis and biologic studies; bone marrow biopsy is not adequate for this purpose and should be performed only for staging. Patients with primary refractoriness, not eligible for intensive salvage therapy including ASCT, who performed a previous biopsy with stored frozen material 6 months or less before enrolment into the study do not have to repeat a new biopsy 7. Patient has at least one site of measurable nodal disease at baseline = 2.0 cm in the longest transverse diameter 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 8. 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 109/L [SI units 1.5 x 109/L] • Platelet count = 100 x 109/L • Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution • 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 9. Clinically euthyroid. Note: Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism 10. Written informed consent was obtained from the patient prior to any study-specific screening procedures 11. Patient has the ability to swallow capsules or tablets 12. Practice acceptable birth control
- •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 age is = 18 years 2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of = 2 3. Patient has a history of DLBCL according to the WHO classification 4. Patient has progressive disease after receiving at least CHOP-R or CHOP-R like first line regimen, standard second line therapy (DHAP, ESHAP, ICE or similar salvage regimens) inclusive ASCT 5. Patient has progressive disease after receiving at least CHOP-R or CHOP-R like first line regimen and is not considered eligible for intensive salvage therapy including ASCT because of age, co-morbidities, impossibility to perform ASCT 6. Patient undergoes at baseline new lymphnode or other pathologic tissue biopsy for confirmation of diagnosis and biologic studies; bone marrow biopsy is not adequate for this purpose and should be performed only for staging. Patients with primary refractoriness, not eligible for intensive salvage therapy including ASCT, who performed a previous biopsy with stored frozen material 6 months or less before enrolment into the study do not have to repeat a new biopsy 7. Patient has at least one site of measurable nodal disease at baseline = 2.0 cm in the longest transverse diameter 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 8. 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 109/L [SI units 1.5 x 109/L] • Platelet count = 100 x 109/L • Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution • 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 9. Clinically euthyroid. Note: Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism 10. Written informed consent was obtained from the patient prior to any study-specific screening procedures 11. Patient has the ability to swallow capsules or tablets 12. Practice acceptable birth control Exclusion criteria 1. Patient has a history of prior treatment with a DAC inhibitors 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 been treated with any other anti lymphoma therapy within 3 weeks of start of study treatment 5. Patient is using any anti-cancer therapy concomitantly 6. Patient has been treated with > 5 prior systemic lines of treatment 7. Patient has received prior radiation therapy = 4 weeks or limited field radiotherapy = 2 weeks prior to start of study treatment 8. Patient treated with allogeneic hematopoietic stem cell transplant with active progressive cGVHD; patient has received DLI = 6 weeks prior to start of study treatment; patient is planned to receive DLI 9. Patient has a history of another malignancy = 3 years before study entry, with the exception of non-melanoma
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