EUCTR2008-004087-40-GB进行中（未招募）不适用
A Phase 2 Study of GCS-100 in Combination with Chemo-immunotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
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. Subject is capable of understanding the purpose and risks of the study and is able to provide written Informed Consent.
- •2. Subject is male or female, aged at least 18 years.
- •3. Subject has histologically confirmed DLBCL, bi-dimensionally measurable by CT scan, with at least 1 lesion =1.5 cm in the greatest diameter. CT scan results must be available prior to dosing to establish eligibility.
- •4. Subject has relapsed or relapsed/refractory disease following at least 2 cycles of R-ICE chemotherapy as salvage chemotherapy, without PR or CR.
- •5. Subject has =4 weeks elapsed between last chemotherapy or immunotherapy exposure.
- •6. Subject has Eastern Collaborative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- •7. Subject’s clinical laboratory values met all of the following criteria within the 14 days prior to Study Day 1, Cycle 1:
- •a) Hemoglobin =9 g/dL
- •b) Absolute neutrophil count >1.0 x 109/L without growth factor support. (ie, no prior myeloid colony stimulating factor use within 4 weeks prior to blood draw for screening absolute neutrophil count)
- •c) Platelets =75 x 109/L
- •d) Total bilirubin =2.0 X Institutional Upper Limit of Normal (IULN)
- •e) Aspartate aminotransferase/alanine aminotransferase <2.5 X IULN, or <5X IULN in subjects with liver involvement of DLBCL
- •f) Creatinine clearance >60 mL/min/1.73 m2
- •g) Serum sodium >130 mmol/L
- •8. Subject’s life expectancy is anticipated to be at least 3 months.
- •9. Female subjects of childbearing potential (ie, women who have not been surgically sterilized or have not been post-menopausal for at least 1 year) and male subjects with partners of childbearing potential must agree to use medically acceptable methods of contraception throughout the study period.
- •10. Subject is willing and able to comply with the prescribed treatment protocol and evaluations.
- •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. Subject has received salvage with R-ICE in whom starting doses of any of the agents were administered at below 75% of the standard dosages defined in this study.
- •2. Subject has received high-dose chemotherapy with hematopoietic stem cell support or allogeneic stem cell transplantation (SCT).
- •3. Subject has rapidly progressive lymphoma or lymphoma threatening organ function.
- •4. Subjects with primary or secondary central nervous system lymphoma.
- •5. Subjects who have had treatment with an experimental (unlicensed) drug within 3 weeks prior to treatment with GCS 100.
- •6. Subject has not recovered from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy.
- •7. Subject has a known history of human immunodeficiency virus-related lymphoma, active hepatitis C, active hepatitis B, or prior history of infection with hepatitis B (HBcAb positive)
- •8. Subject has a clinically relevant active infection and/or a serious co-morbid medical condition such as recent myocardial infarction (within the last 6 months and no electrocardiographic evidence of acute ischemia or new conduction system abnormalities), unstable angina, difficult-to-control congestive heart failure, uncontrolled hypertension, difficult-to-control cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, and/or cirrhosis.
- •9. Subject had major surgery within 4 weeks prior to Study Day 1.
- •10. If female, subject is pregnant or breastfeeding.
- •11. Subject has a concomitant disease or condition, including laboratory abnormalities, which in the opinion of the Investigator could interfere with the conduct of the study or could put the subject at unacceptable risk.
研究者
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