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
229 Greenhill Road
Dulwich SA 5065
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
Hypothesis: Relapsed diffuse large B-cell lymphoma (DLBCL) patients who received R-CHOP as their primary therapy have a poor outcome compared to patients who received CHOP as their primary therapy.

The objective of this study is to assess the impact of R-CHOP on the overall survival of autologous stem cell transplant for patients with relapsed DLBCL. The information gained may benefit patients by altering standard therapy for this patient population.
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.