Condition category
Cancer
Date applied
14/05/2008
Date assigned
10/07/2008
Last edited
10/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.suht.nhs.uk

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)

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

Results - basic reporting

Publication summary

2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26849853

Publication citations

Additional files

Editorial Notes

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.