A phase II study of GCS-100 in combination with chemo-immunotherapy in relapsed or refractory diffuse large B-cell lymphoma

Prospect Therapeutics, Inc. (USA)0 个研究点目标入组 28 人开始时间: 2008年10月30日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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, bidimensionally measurable by computerised tomography (CT) scan, with at least one lesion greater than or equal to 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 two cycles of R-ICE chemotherapy as salvage chemotherapy, without partial response (PR) or complete response (CR)
•5. Subject has greater than or equal to 4 weeks elapsed between last chemotherapy or immunotherapy exposure
•6. Subject has Eastern Collaborative Oncology Group (ECOG) performance status of 0 or 1

•1. Subject has received high-dose chemotherapy with haematopoietic 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 ischaemia 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

发起方

Prospect Therapeutics, Inc. (USA)