Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000802606
Ethics application status
Approved
Date submitted
22/12/2005
Date registered
23/12/2005
Date last updated
19/01/2006
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
SHIRT
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
Hodgkin's

Intervention/exposure
Study type
Interventional
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
Uncontrolled

Outcomes
Primary outcome [1] 1381 0
Safety
Timepoint [1] 1381 0
Primary outcome [2] 1382 0
Efficacy
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

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

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

Summary
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

Contacts
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
Australia
Phone 10004 0
+61 8 94312888
Fax 10004 0
+61 8 94312889
Email 10004 0
harvey.turner@health.wa.gov.au
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
Australia
Phone 932 0
+61 8 94312886
Fax 932 0
+61 8 94312881
Email 932 0
michael.leahy@health.wa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.