Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PR-CS011
Study information
Scientific title
A phase II study of GCS-100 in combination with chemo-immunotherapy in relapsed or refractory diffuse large B-cell lymphoma
Acronym
Study hypothesis
The primary objective of this study is to assess the efficacy of GCS-100 with rituximab, ifosfomide, mesna, carboplatin and etoposide (R-ICE) chemotherapy in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The secondary objective is to determine the safety of GCS-100 in conjunction with cytotoxic chemotherapy.
Ethics approval
The study was approved by the London Research Ethics Committee (REC) of Northwick Park Hospital on the 6th October 2008 (ref: 08/H0718/57)
Study design
Interventional, single-arm, single-centre trial
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Intervention
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 following:
Days 1 - 5: GCS-100 160 mg/m^2/day intravenously (IV) over 1 hour.
Dosing with GCS-100 will be followed at least 1 hour later by:
Day 1: rituximab 375 mg/m^2 IV
Days 2: carboplatin dose area under the curve (AUC) = 5 mg/mL x min (maximum 800 mg) IV
Days 2 - 4: ifosfamide 1667 mg/m^2 IV
Days 2 - 4: mesna 1667 mg/m^2 IV or oral
Days 2 - 4: etoposide 100 mg/m^2 IV
Intervention type
Drug
Phase
Phase II
Drug names
GCS-100, rituximab, ifosfomide, mesna, carboplatin, etoposide
Primary outcome measure
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 outcome measures
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.
Overall trial start date
01/12/2008
Overall trial end date
01/12/2009
Reason abandoned (if study stopped)
Lack of funding/sponsorship
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
14 - 28
Participant 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
Recruitment start date
01/12/2008
Recruitment end date
01/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Barts and the London NHS Trust
London
EC1A 7BE
United Kingdom
Sponsor information
Organisation
Prospect Therapeutics, Inc. (USA)
Sponsor details
12 Gill Street
Suite 4700
Woburn
MA 01801
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Prospect Therapeutics, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list