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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00005589
Registration number
NCT00005589
Ethics application status
Date submitted
2/05/2000
Date registered
27/01/2003
Date last updated
17/09/2013
Titles & IDs
Public title
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
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Scientific title
Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy
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Secondary ID [1]
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EBMT-EBMTLYM1
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Secondary ID [2]
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CDR0000067665
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to disease progression
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Assessment method [1]
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Secondary outcome [1]
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Response rate and survival
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Secondary outcome [2]
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Molecular remission rates
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Safety
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Relapsed or resistant follicular non-Hodgkin's lymphoma (NHL)
* No evidence of transformation to high grade or diffuse large B-cell NHL
* CD20 positive with no evidence of transformation
* Achievement of complete remission (CR) or very good partial remission (VGPR) following reinduction chemotherapy with any standard regimen
* Includes patients who fail to respond to first-line chemotherapy but who achieve CR or VGPR after proceeding directly to second-line chemotherapy
* Platelet count greater than 100,000/mm^3 after induction chemotherapy and before randomization
* No CNS involvement
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin normal
* ALT no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN
* Hepatitis B negative
* Hepatitis C negative
Renal:
* Creatinine no greater than 2 times ULN
* BUN no greater than 2 times ULN
Cardiovascular:
* No inadequate cardiac function
Pulmonary:
* No inadequate pulmonary function
Other:
* Not pregnant or nursing
* HIV negative
* No other uncontrolled serious medical conditions
* No other malignancy within the past 5 years except nonmelanoma skin tumors or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* More than 12 months since prior CD20 therapy, including rituximab
* No prior peripheral blood stem cell transplantation
Chemotherapy:
* See Disease Characteristics
* No more than 3 prior chemotherapy regimens for NHL
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to greater than 30% of bone marrow
Surgery:
* Not specified
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/1999
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2013
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Sample size
Target
460
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
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Westmead Institute for Cancer Research at Westmead Hospital - Westmead
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Royal Brisbane and Women's Hospital - Brisbane
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Royal Adelaide Hospital Cancer Centre - Adelaide
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Queen Elizabeth Hospital - Woodville
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Royal Melbourne Hospital - Parkville
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Fremantle Hospital - Fremantle
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Royal Perth Hospital - Perth
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2050 - Sydney
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2145 - Westmead
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4029 - Brisbane
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5000 - Adelaide
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5011 - Woodville
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3050 - Parkville
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6160 - Fremantle
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Recruitment postcode(s) [8]
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6000 - Perth
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Vienna
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Funding & Sponsors
Primary sponsor type
Other
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Name
EBMT Solid Tumors Working Party
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Other
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Lymphoma Trials Office
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Ethics approval
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin's lymphoma.
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Trial website
https://clinicaltrials.gov/study/NCT00005589
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Trial related presentations / publications
Pettengell R, Schmitz N, Gisselbrecht C, Smith G, Patton WN, Metzner B, Caballero D, Tilly H, Walewski JA, Bence-Bruckler I, To B, Geisler CH, Schots R, Kimby E, Taverna CJ, Kozak T, Dreger P, Uddin R, Ruiz de Elvira C, Goldstone AH. Rituximab purging and/or maintenance in patients undergoing autologous transplantation for relapsed follicular lymphoma: a prospective randomized trial from the lymphoma working party of the European group for blood and marrow transplantation. J Clin Oncol. 2013 May 1;31(13):1624-30. doi: 10.1200/JCO.2012.47.1862. Epub 2013 Apr 1.
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Public notes
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Contacts
Principal investigator
Name
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Ruth Pettengell, MD
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Address
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St George's, University of London
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00005589
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