Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000190404
Ethics application status
Approved
Date submitted
27/03/2007
Date registered
2/04/2007
Date last updated
2/04/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Extended treatment with rituximab in patients with B-cell post-transplant lymphoproliferative diease
Scientific title
A multicentre phase II trial of extended treatment with rituximab to assess complete remission rate in patients with B-cell post-transplant lymphoproliferative diease
Universal Trial Number (UTN)
Trial acronym
SLPT/01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post solid organ transplant lymphoproliferative disease 1708 0
Condition category
Condition code
Other 1801 1801 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment with 4 courses, one per week during 4 weeks, of intravenous Rituximab at a dose of 375 mg/m2 (standard doses). Patients who progressed were excluded from the study. Patients in complete remission after 4 courses were followed without further treatment. Participants in complete remission after 4 courses were followed up every 3 monts during 2 years or until progression. Patients with partial response received another 4 weekly courses of rituximab at the same doses. Participants in complete remission after 8 courses were followed up every 3 monts during 2 years or until progression
Intervention code [1] 1671 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2521 0
Complete remission rate
Timepoint [1] 2521 0
8 weeks after the end of the treatment (with CT scan). If there were clinical data suggesting progression, patients could be evaluated at 4 weeks after the end of treatment.
Secondary outcome [1] 4353 0
Overall response rate
Timepoint [1] 4353 0
At 8 weeks after the end of treatment. If there were clinical data suggesting progression patients could be evaluated at 4 weeks after the end of treatment.
Secondary outcome [2] 4354 0
Overall survival and progression-free survival at 2 years after the end of treatment
Timepoint [2] 4354 0
At 2 years after the end of treatment.

Eligibility
Key inclusion criteria
Signed informed consent, untreated B-cell lymphoproliferative disease, CD20 expression.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Central nervous system disease, serious concomitant diseases.

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 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 497 0
Spain
State/province [1] 497 0

Funding & Sponsors
Funding source category [1] 1953 0
Other Collaborative groups
Name [1] 1953 0
GELTAMO: Spanish Group of Lymphoma
Country [1] 1953 0
Primary sponsor type
Individual
Name
Alberto Fernández de Sevilla on behalf of the Catalan Institute of Oncology
Address
Country
Secondary sponsor category [1] 1765 0
None
Name [1] 1765 0
N/A
Address [1] 1765 0
Country [1] 1765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3649 0
Ciutat Sanitaria i Universitaria de Bellvitge
Ethics committee address [1] 3649 0
Ethics committee country [1] 3649 0
Spain
Date submitted for ethics approval [1] 3649 0
Approval date [1] 3649 0
17/04/2002
Ethics approval number [1] 3649 0
93/02

Summary
Brief summary
Not randomized trial of treatment with standard doses of rituximab for untreated B-cell lymphoproliferative disease. Treatment regimen was adapted to early response, patients received 4 to 8 courses of rituximab.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27774 0
Address 27774 0
Country 27774 0
Phone 27774 0
Fax 27774 0
Email 27774 0
Contact person for public queries
Name 10860 0
Eva González Barca
Address 10860 0
Av. Gran Vía s/n Km 2,7
L'Hospitalet de LLobregat
08907 Barcelona
Country 10860 0
Spain
Phone 10860 0
+34 93 2607750
Fax 10860 0
+34 93 2607797
Email 10860 0
[email protected]
Contact person for scientific queries
Name 1788 0
Eva González Barca
Address 1788 0
Av. Gran Vía s/n Km 2,7
L'Hospitalet de LLobregat
08907 Barcelona
Country 1788 0
Spain
Phone 1788 0
+34 93 2607750
Fax 1788 0
+34 93 2607797
Email 1788 0
[email protected]

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.