Short Chemo Radio Immunotherapy in Follicular Lymphoma Trial of Y-90 ibritumomab tiuxetan (Zevalin®) as therapy for first and second relapse in follicular lymphoma

ISRCTN ISRCTN44808098
DOI https://doi.org/10.1186/ISRCTN44808098
ClinicalTrials.gov number NCT00637832
Secondary identifying numbers 2.0
Submission date
14/05/2008
Registration date
10/07/2008
Last edited
27/07/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-zevalin-and-chemotherapy-for-relapsed-follicular-lymphoma

Study website

Contact information

Prof Timothy Illidge
Scientific

University of Southampton Clinical Trials Unit
MP 131, Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone +44 (0)23 8079 5154
Email kc8@soton.ac.uk

Study information

Study designOpen-label, single-arm, non-randomised, prospective, phase 2 study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.
Scientific titleShort Chemo Radio Immunotherapy in Follicular Lymphoma Trial of Y-90 ibritumomab tiuxetan (Zevalin®) as therapy for first and second relapse in follicular lymphoma
Study acronymSCHRIFT
Study objectivesChemotherapy 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(s)Central Manchester Research Ethics Committee. Date of approval: 07/09/2007
Health condition(s) or problem(s) studiedFollicular lymphoma
InterventionThis 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Y-90 ibritumomab tiuxetan (Zevalin®)
Primary outcome measureOverall 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 measures1. Time to disease progression
2. Time to next treatment
3. Response duration for the responders
4. Safety of the regimen under investigation
Overall study start date23/05/2008
Completion date20/08/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Total final enrolment50
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment21/04/2008
Date of final enrolment20/04/2010

Locations

Countries of recruitment

  • England
  • United Kingdom
  • Wales

Study participating centres

Southampton General Hospital
Southampton University Hospitals NHS Trust
Somers Cancer Research Building, MP 824
Tremona Road
Southampton
SO16 6YD
United Kingdom
North Wales Cancer Treatment Centre
Clinical Trials Unit
Glan Clwyd Hospital
Bodelwyddan
LL18 5UJ
United Kingdom
St Bartholomew Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
Christie Hospital
Christie Hospital NHS Trust
Dept of Medical Oncology
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
Poole Hospital
Poole Hospitals NHS Trust, Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom
Weston Park Hospital
Sheffield Teaching Hospitals NHS Trust
Academic Unit of Clinical Oncology
Cancer Research Centre
Whitham Road
Sheffield
S10 2SJ
United Kingdom
St Marys Hospital
Portsmouth Hospitals NHS Trust, Room 20, Exton 1
Portsmouth Oncology Centre
Portsmouth
PO3 6AD
United Kingdom
Churchill Hospital
Oxford Radcliffe Hospitals NHS Trust
Research Institute
Oxford Cancer and Haematology Centre
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
Mount Vernon Cancer Centre
East & North Hertfordshire NHS Trust (Mount Vernon)
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
Royal Free Hospital
Royal Free Hospital NHS Trust
Dept of Academic Oncology
Pond Street
London
NW3 2QG
United Kingdom
Guys Hospital
Guys & St Thomas
Department of Haematology
4th Floor, Southwark Wing
Great Maze Pond
London
SE1 9RT
United Kingdom
Addensbrookes Hospital
Cambridge Cancer Trials Centre
Oncology Clinical Trials (S4), Box 279
Hills Road
Cambridge
CB2 0QQ
United Kingdom
St James’s Hospital
Leeds Teaching Hospitals NHS Trust
Dept of Haematology
Level 3, Bexley Wing
Leeds
LS9 7TF
United Kingdom
Velindre Cancer Centre
Velindre Road
Whitchurch
Cardiff
CF14 2TL
United Kingdom
St Georges Hospital
St Georges Hospital, Research Nurses Office
Lanesborough Wing Outpatients
Blackshaw Road
London
SW17 0RE
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Clinical Governance Directorate
Research & Development
Trust Management Offices, MP 18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Website http://www.suht.nhs.uk
ROR logo "ROR" https://ror.org/0485axj58

Funders

Funder type

Charity

Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom
Roche (Switzerland)
Government organisation / For-profit companies (industry)
Alternative name(s)
F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
Location
Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2016 Yes No
Plain English results 27/07/2022 No Yes

Editorial Notes

27/07/2022: Cancer Research UK plain English results summary link and total final enrolment added.
10/03/2016: Publication reference added. The overall trial end date has been updated from 20/04/2010 to 27/01/2015, and the recruitment dates have been updated from 21/04/2008 - 27/01/2015 to 23/05/2008 - 20/08/2010. In addition, 14 further trial participating centres have been added.
26/02/2016: No publications found, verifying study status with principal investigator.