Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000803099
Ethics application status
Not yet submitted
Date submitted
20/09/2010
Date registered
27/09/2010
Date last updated
27/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) on Overall Survival of Patients with Relapsed Diffuse Large B-Cell Lymphoma Post-Autologous Stem Cell Transplant
Scientific title
The Effect of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) on Overall Survival of Patients with Relapsed Diffuse Large B-Cell Lymphoma Post-Autologous Stem Cell Transplant
Secondary ID [1] 252723 0
none
Universal Trial Number (UTN)
U1111-1117-1683
Trial acronym
The Possible Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diffuse large B-cell lymphoma 258216 0
Condition category
Condition code
Blood 258393 258393 0 0
Haematological diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Not applicable - retrospective chart review study.

The retrospective chart review will involve the review of 150 - 200 patient charts, dating from 1996 to 2010, to examine the outcomes for patients with relapsed Diffuse Large B-Cell Lymphoma (DLBCL) undergoing auto-Stem Cell Transplant (auto-SCT) at the Haematology & Oncology Clinics of Australia (HOCA). Cohort analysis will be completed on two groups of patients: 1) patients who received CHOP chemotherapy and underwent auto-SCT for relapsed DLBCL and 2) patients who received R-CHOP for relapsed DLBCL.

Total length of time for study is approximately 12 months with an expected end date of December 2011.
Intervention code [1] 257234 0
Not applicable
Comparator / control treatment
Cohort analysis will be completed on two groups of patients: 1) patients who received CHOP chemotherapy and underwent auto-SCT for relapsed DLBCL and 2) patients who received R-CHOP for relapsed DLBCL.
Control group
Historical

Outcomes
Primary outcome [1] 259238 0
Overall survival as determined by retrospective chart review and correlation with electronic medical records.
Timepoint [1] 259238 0
Overall survival will be measured in months from date of autologous stem cell transplant, with no maximum timepoint for this outcome measure
Secondary outcome [1] 265645 0
Time to relapse - as determined by clinical assessments
Timepoint [1] 265645 0
Time to relapse will be measured in months from date of autologous stem cell transplant, with no maximum timepoint for this outcome measure

Eligibility
Key inclusion criteria
Patients with histologically-confirmed DLBCL

Must have received CHOP (CHOP 14, CHOP 21) or R-CHOP (R-CHOP 14, R-CHOP 21) chemotherapy as first-line therapy

Must have received an auto-SCT transplant after relapse
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with low-grade lymphoma at presentation or relapse.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257678 0
Charities/Societies/Foundations
Name [1] 257678 0
Haematology and Oncology Clinics of Australia (HOCA) Research Centre
Country [1] 257678 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Haematology and Oncology Clinics (HOCA) Research Centre
Address
1-3, 11 Camford Street
Milton QLD 4064
Country
Australia
Secondary sponsor category [1] 256894 0
None
Name [1] 256894 0
Address [1] 256894 0
Country [1] 256894 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259706 0
Bellberry
Ethics committee address [1] 259706 0
Ethics committee country [1] 259706 0
Australia
Date submitted for ethics approval [1] 259706 0
20/10/2010
Approval date [1] 259706 0
Ethics approval number [1] 259706 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31663 0
Address 31663 0
Country 31663 0
Phone 31663 0
Fax 31663 0
Email 31663 0
Contact person for public queries
Name 14910 0
Miriam Dwyer
Address 14910 0
General Manager Haematology and Onclogly Clinics of Australia (HOCA) Research Centre
1-3, 11 Camford Street Milton QLD 4064
Country 14910 0
Australia
Phone 14910 0
+617 3737 4516
Fax 14910 0
+617 3737 4501
Email 14910 0
[email protected]
Contact person for scientific queries
Name 5838 0
Dr James Morton
Address 5838 0
Director, Haematology and Onclogly Clinics of Australia (HOCA); Clinical Haematologist
Corporate Office: 1-3, 11 Camford Street Milton QLD 4064
Country 5838 0
Australia
Phone 5838 0
+617 3737 4500
Fax 5838 0
+617 3737 4501
Email 5838 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.