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
Contact information
Prof Timothy Illidge
Scientific
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 |
|---|---|
| kc8@soton.ac.uk |
Study information
| Study design | Open-label, single-arm, non-randomised, prospective, phase 2 study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 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 |
| Study acronym | SCHRIFT |
| Study objectives | 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(s) | Central Manchester Research Ethics Committee. Date of approval: 07/09/2007 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 23/05/2008 |
| Completion date | 20/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/04/2008 |
| Date of final enrolment | 20/04/2010 |
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
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
Glan Clwyd Hospital
Bodelwyddan
LL18 5UJ
United Kingdom
St Bartholomew Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
London
EC1A 7BE
United Kingdom
Christie Hospital
Christie Hospital NHS Trust
Dept of Medical Oncology
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
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
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
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
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
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
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
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
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
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
Dept of Haematology
Level 3, Bexley Wing
Leeds
LS9 7TF
United Kingdom
Velindre Cancer Centre
Velindre Road
Whitchurch
Cardiff
CF14 2TL
United Kingdom
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
Lanesborough Wing Outpatients
Blackshaw Road
London
SW17 0RE
United Kingdom
Sponsor information
Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre
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" |
https://ror.org/0485axj58 |
Funders
Funder type
Charity
Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations
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)
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 share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not 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.
