Contact information
Type
Scientific
Primary contact
Prof Timothy Illidge
ORCID ID
Contact details
University of Southampton Clinical Trials Unit
MP 131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8079 5154
kc8@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00637832
Protocol/serial number
2.0
Study information
Scientific title
Short Chemo Radio Immunotherapy in Follicular Lymphoma Trial of Y-90 ibritumomab tiuxetan (Zevalin®) as therapy for first and second relapse in follicular lymphoma
Acronym
SCHRIFT
Study hypothesis
Chemotherapy plus rituximab combinations (6-8 courses) have consistently demonstrated increased complete response rates and markedly prolonged progression-free survival (PFS) when compared to chemotherapy alone in the first-line and relapse settings in patients with follicular non-Hodgkin's Lymphoma (NHL). However, this protracted duration of therapy can be difficult for many patients and increases the incidence of several cumulative toxicities. Abbreviated treatment regimens that deliver equally high response rates and response duration would therefore be attractive alternatives for patients.
Ethics approval
Central Manchester Research Ethics Committee. Date of approval: 07/09/2007
Study design
Open-label, single-arm, non-randomised, prospective, phase 2 study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.
Condition
Follicular lymphoma
Intervention
This is an open-label, single-arm, non-randomised controlled trial.
Weeks 0, 3 and 6: Three cycles of rituximab 375 mg/m^2 (intravenous [IV]) + chemotherapy (R-Chemo)
Week 9: Rituximab IV 250 mg/m^2
Week 10: Rituximab followed by ibritumomab tiuxetan (Zevalin®). Dosage: Rituximab IV 250 mg/m^2; for Zevalin®: if platelet count >150 x 10^9L, Zevalin® at 14.8 MBq/kg, or if platelet count between >100 x 10^9L and <150 x 10^9L, dose adjusted Zevalin® at 11.1 MBq/kg)
Total duration of interventions: 10 weeks
Follow-up: Weekly until Week 22, then at various intervals up to 5 years
Please use the following contact details to request a patient information sheet:
Ms Louisa Little
University of Southampton Clinical Trials Unit
MP 131, F Level
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD, UK
Email: lal@soton.ac.uk
Intervention type
Drug
Phase
Phase II
Drug names
Y-90 ibritumomab tiuxetan (Zevalin®)
Primary outcome measure
Overall response rate (ORR), including combined complete response (CR) and partial response (PR). Follow-up: Weekly until Week 22, then at various intervals up to 5 years.
Secondary outcome measures
1. Time to disease progression
2. Time to next treatment
3. Response duration for the responders
4. Safety of the regimen under investigation
Overall trial start date
23/05/2008
Overall trial end date
20/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females. Patients must be aged 18 years or older
2. Patients must have a histologically confirmed CD20 +ve follicular lymphoma
3. Patients with at least one of the following symptoms requiring initiation of treatment (as outlined by the modified British National Lymphoma Investigation [BNLI]/Groupe d'Etude des Lymphomes Folliculaires [GELF] criteria):
3.1. Nodal mass >5 cm in its greater diameter
3.2. B symptoms
3.3. Elevated serum lactate dehydrogenase (LDH) or beta-2-microglobulin
3.4. Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm)
3.5. Symptomatic splenic enlargement
3.6. Compressive syndrome
4. Patients must have an World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (ECOG-PS) less than or equal to 2 and an anticipated survival of at least 6 months
5. First or second relapse after R-chemo (rituximab plus chemotherapy) regimen or chemotherapy alone. Relapse must have occurred at least 6 months after an R-Chemo regimen but may have occurred less than 6 months after chemotherapy alone
6. Patients must have adequate renal function (defined as serum creatinine <1.5 times upper limit of normal), hepatic function (defined as total bilirubin <1.5 times upper limit of normal), and hepatic transaminases (defined as aspartate transaminase [AST] <5 times upper limit of normal)
7. Patients must have given written informed consent prior to study entry
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Patients who have received investigational drugs <4 weeks prior to entry or who have not recovered from the toxic effects of such therapy
2. Patients who have received previous radioimmunotherapy
3. Patients with active obstructive hydronephrosis
4. Patients with initial disease bulk greater than 10 cm
5. Patients with central nervous system (CNS) disease
6. Patients with evidence of active infection requiring intravenous antibiotics at the time of study entry
7. Patients with advanced heart disease or other serious illness that would preclude evaluation
8. Patients with large pleural or peritoneal effusions
9. Patients with known HIV infection
10. Known hypersensitivity to murine antibodies or proteins
11. Patients who are pregnant or breast-feeding. Male and female patients must agree to use effective contraception for 12 months following Y-90 ibritumomab tiuxetan (Zevalin®) antibody therapy
12. Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years
Recruitment start date
21/04/2008
Recruitment end date
20/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton General Hospital
Southampton University Hospitals NHS Trust
Somers Cancer Research Building, MP 824
Tremona Road
Southampton
SO16 6YD
United Kingdom
Trial participating centre
North Wales Cancer Treatment Centre
Clinical Trials Unit
Glan Clwyd Hospital
Bodelwyddan
LL18 5UJ
United Kingdom
Trial participating centre
St Bartholomew Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
Trial participating centre
Christie Hospital
Christie Hospital NHS Trust
Dept of Medical Oncology
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
Trial participating centre
Poole Hospital
Poole Hospitals NHS Trust, Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom
Trial participating centre
Weston Park Hospital
Sheffield Teaching Hospitals NHS Trust
Academic Unit of Clinical Oncology
Cancer Research Centre
Whitham Road
Sheffield
S10 2SJ
Trial participating centre
St Marys Hospital
Portsmouth Hospitals NHS Trust, Room 20, Exton 1
Portsmouth Oncology Centre
Portsmouth
PO3 6AD
United Kingdom
Trial participating centre
Churchill Hospital
Oxford Radcliffe Hospitals NHS Trust
Research Institute
Oxford Cancer and Haematology Centre
Old Road
Headington
Oxford
OX3 7LJ
Trial participating centre
Mount Vernon Cancer Centre
East & North Hertfordshire NHS Trust (Mount Vernon)
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
Trial participating centre
Royal Free Hospital
Royal Free Hospital NHS Trust
Dept of Academic Oncology
Pond Street
London
NW3 2QG
United Kingdom
Trial participating centre
Guys Hospital
Guys & St Thomas
Department of Haematology
4th Floor, Southwark Wing
Great Maze Pond
London
SE1 9RT
United Kingdom
Trial participating centre
Addensbrookes Hospital
Cambridge Cancer Trials Centre
Oncology Clinical Trials (S4), Box 279
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Trial participating centre
St James’s Hospital
Leeds Teaching Hospitals NHS Trust
Dept of Haematology
Level 3, Bexley Wing
Leeds
LS9 7TF
Trial participating centre
Velindre Cancer Centre
Velindre Road
Whitchurch
Cardiff
CF14 2TL
United Kingdom
Trial participating centre
St Georges Hospital
St Georges Hospital, Research Nurses Office,
Lanesborough Wing Outpatients
Blackshaw Road
London
SW17 0RE
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Clinical Governance Directorate
Research & Development
Trust Management Offices
MP 18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Roche (Switzerland)
Alternative name(s)
F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26849853