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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
SHIRT (Salvage Hodgkins Immunoradiotherapy)
Scientific title
A Pilot Study of Radioimmunotherapy with Iodine-131 Basiliximab Anti-CD25 Antibody for Relapsed or Refractory Hodgkins Disease and Other Lymphoproliferative Malignancies Expressing IL-2R
Secondary ID [1] 228 0
Single Centre Open-Label Non-Randomised Physician Sponsored Pilot Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoproliferative Malignancies (Relapsed or Refractory) 961 0
Condition category
Condition code
Cancer 1031 1031 0 0

Study type
Description of intervention(s) / exposure
A Pilot Study of Radioimmunotherapy with Iodine-131 Basiliximab Anti-CD25 Antibody for Relapsed or Refractory Hodgkins Disease and Other Lymphoproliferetive Malignancies Expressing IL-2R
Intervention code [1] 815 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 1381 0
Timepoint [1] 1381 0
Primary outcome [2] 1382 0
Timepoint [2] 1382 0
Primary outcome [3] 1383 0
Progression Free Survival
Timepoint [3] 1383 0
Secondary outcome [1] 2447 0
Overall Survival
Timepoint [1] 2447 0

Key inclusion criteria
Refractory histologically proven lymphoma i.e. patients who have been treated with at least a first or second line conventional chemotherapy which may include ABMT/PBSCT and have subsequently relapsed.Lymphoproliferative malignancies immunohistocytochemically shown to express IL-2R (CD25)Measurable disease either clinically or radiologically by X-ray, CT, US or MRI or FDG PET scan. Age =18 years.Life expectancy = 3 months.ECOG performance status < 2No anti-lymphoma treatment in the previous 6 weeks (if on steroids a stable dosage over the same period is required).Haematological and biochemical indices:i) Absolute neutrophil count of =1.5 x 10^9 /litre.ii) Haemoglobin = 10g/dl.iii) Platelet count = 100 x 10^9/litre.iv) Plasma creatinine =150 µmol/l or GFR = 50ml/min.v) Plasma bilirubin = 30 µmol/l. vi) ALT/AST =2x upper limit of normal (5x upper limit of normal in the presence of liver metastases).vii) Thyroid function either normal or if the patient has a known thyroid abnormality, it must be stable on treatment.Signed written informed consent.
Minimum age
18 Years
Maximum age
Not stated
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Poor renal function (creatinine level > 150µmol/l), poor hepatic function (total bilirubin level > 30mmol/l, transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma. Poor bone marrow reserve as defined by neutrophils < 1.5 x 10^9/L or platelets <100 x 10^9/L. Cardiac failure (NYHA class III-IV)Patients who are poor medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection.Documented infection with HIV, HBC, HHV8 and HBV (in the absence of vaccination)Central nervous system or meningeal involvement by lymphomaAny serious active disease or co-morbid condition (according to the investigator’s decision and information provided in the IDB).Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage O (in situ) cervical carcinomaTreatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the studyPregnant or lactating women, or women of child bearing potential in whom pregnancy cannot be excluded. Patients of child bearing/child fathering potential not using adequate medically approved contraception 4 weeks before, during the study and for six months afterwards.Adult patient unable to provide informed consent because of intellectual impairment.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 1 / Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1133 0
Name [1] 1133 0
Physician Sponsored
Address [1] 1133 0
Country [1] 1133 0
Primary sponsor type
Government body
South Metropolitan Area Health Service WA
Secondary sponsor category [1] 990 0
Name [1] 990 0
Fremantle Hospital and Health Service
Address [1] 990 0
Country [1] 990 0

Ethics approval
Ethics application status
Ethics committee name [1] 2446 0
Fremantle Hospital and Health Service
Ethics committee address [1] 2446 0
Ethics committee country [1] 2446 0
Date submitted for ethics approval [1] 2446 0
Approval date [1] 2446 0
Ethics approval number [1] 2446 0

Brief summary
Radiolabelled antibody treatment of Hodgkin's disease and other lymphomas which have either not responded to conventional chemotherapy and/or radiotherapy, or which have relapsed following initial response to standard treatment.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 35263 0
Address 35263 0
Country 35263 0
Phone 35263 0
Fax 35263 0
Email 35263 0
Contact person for public queries
Name 10004 0
Professor J Harvey Turner
Address 10004 0
Department of Nuclear Medicine
Fremantle Hospital
Alma St
Fremantle WA 6160
Country 10004 0
Phone 10004 0
+61 8 94312888
Fax 10004 0
+61 8 94312889
Email 10004 0
Contact person for scientific queries
Name 932 0
Dr. Michael F Leahy
Address 932 0
Department of Haematology
Fremantle Hospital
Alma St
Fremantle WA 6160
Country 932 0
Phone 932 0
+61 8 94312886
Fax 932 0
+61 8 94312881
Email 932 0

No information has been provided regarding IPD availability
Summary results
No Results