Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Cancer Diffuse non-Hodgkin's lymphoma
Conditions
Interventions
This is a single-arm trial of GCS-100 with R-ICE chemotherapy administered in 21-day cycles (a maximum of four chemotherapy cycles per participant). Each 21-day treatment cycle consists of the followi
Sponsors
Prospect Therapeutics, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Response: overall response rate, defined as the sum of the number of CR rate and PR rate. CR and PR will be defined according to the International Harmonisation Project for Lymphoma criteria. 2. Imaging: CT scans will be obtained at baseline and every two cycles to assess for response. They will be evaluated according to the International Harmonisation Project for Lymphoma. Total duration of follow-up for the primary and secondary outcome measures: 16 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the safety of GCS-100 in conjunction with cytotoxic chemotherapy by collecting adverse event data and monitoring blood parameters, etc. Total duration of follow-up for the primary and secondary outcome measures: 16 weeks. | — |
Countries
United Kingdom
Outcome results
None listed