Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
EBMT-EBMTLYM1
Secondary ID [2] 0 0
CDR0000067665
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - filgrastim
Other interventions - rituximab
Treatment: Drugs - carmustine
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - cytarabine
Treatment: Drugs - etoposide
Treatment: Drugs - melphalan
Treatment: Surgery - bone marrow ablation with stem cell support
Treatment: Surgery - peripheral blood stem cell transplantation

Other interventions: filgrastim


Other interventions: rituximab


Treatment: Drugs: carmustine


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: cytarabine


Treatment: Drugs: etoposide


Treatment: Drugs: melphalan


Treatment: Surgery: bone marrow ablation with stem cell support


Treatment: Surgery: peripheral blood stem cell transplantation
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to disease progression
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Response rate and survival
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Molecular remission rates
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Safety
Timepoint [3] 0 0

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
460
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [4] 0 0
Royal Adelaide Hospital Cancer Centre - Adelaide
Recruitment hospital [5] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [7] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5011 - Woodville
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerpen
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Ghent
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Belgium
State/province [6] 0 0
Liege
Country [7] 0 0
Belgium
State/province [7] 0 0
Mont-Godinne Yvoir
Country [8] 0 0
Belgium
State/province [8] 0 0
Roeselaere
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Prague
Country [12] 0 0
Denmark
State/province [12] 0 0
Aalborg
Country [13] 0 0
Denmark
State/province [13] 0 0
Copenhagen
Country [14] 0 0
Denmark
State/province [14] 0 0
Odense
Country [15] 0 0
France
State/province [15] 0 0
Angers
Country [16] 0 0
France
State/province [16] 0 0
Caen
Country [17] 0 0
France
State/province [17] 0 0
Grenoble
Country [18] 0 0
France
State/province [18] 0 0
Lyon
Country [19] 0 0
France
State/province [19] 0 0
Melun
Country [20] 0 0
France
State/province [20] 0 0
Montpellier
Country [21] 0 0
France
State/province [21] 0 0
Nantes
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
France
State/province [23] 0 0
Pierre Benite
Country [24] 0 0
France
State/province [24] 0 0
Rennes
Country [25] 0 0
France
State/province [25] 0 0
Rouen
Country [26] 0 0
France
State/province [26] 0 0
Tours
Country [27] 0 0
France
State/province [27] 0 0
Villejuif
Country [28] 0 0
Germany
State/province [28] 0 0
Augsburg
Country [29] 0 0
Germany
State/province [29] 0 0
Bremen
Country [30] 0 0
Germany
State/province [30] 0 0
Goettingen
Country [31] 0 0
Germany
State/province [31] 0 0
Hamburg
Country [32] 0 0
Germany
State/province [32] 0 0
Homburg
Country [33] 0 0
Germany
State/province [33] 0 0
Nuernberg
Country [34] 0 0
Germany
State/province [34] 0 0
Oldenburg
Country [35] 0 0
Germany
State/province [35] 0 0
Tuebingen
Country [36] 0 0
Israel
State/province [36] 0 0
Tel Hashomer
Country [37] 0 0
New Zealand
State/province [37] 0 0
Auckland
Country [38] 0 0
New Zealand
State/province [38] 0 0
Christchurch
Country [39] 0 0
New Zealand
State/province [39] 0 0
Hamilton
Country [40] 0 0
Poland
State/province [40] 0 0
Warsaw
Country [41] 0 0
Poland
State/province [41] 0 0
Wroclaw
Country [42] 0 0
Portugal
State/province [42] 0 0
Lisboa
Country [43] 0 0
Spain
State/province [43] 0 0
Alicante
Country [44] 0 0
Spain
State/province [44] 0 0
Barakaldo Bilbao
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
Caceres
Country [47] 0 0
Spain
State/province [47] 0 0
Cadiz
Country [48] 0 0
Spain
State/province [48] 0 0
Castellon
Country [49] 0 0
Spain
State/province [49] 0 0
El Palmar
Country [50] 0 0
Spain
State/province [50] 0 0
Galdakao Vizcaya
Country [51] 0 0
Spain
State/province [51] 0 0
Granada
Country [52] 0 0
Spain
State/province [52] 0 0
Jaen
Country [53] 0 0
Spain
State/province [53] 0 0
La Coruna
Country [54] 0 0
Spain
State/province [54] 0 0
Las Palmas de Gran Canaria
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Murcia
Country [57] 0 0
Spain
State/province [57] 0 0
Oviedo
Country [58] 0 0
Spain
State/province [58] 0 0
Palma De Mallorca
Country [59] 0 0
Spain
State/province [59] 0 0
Salamanca
Country [60] 0 0
Spain
State/province [60] 0 0
Santander
Country [61] 0 0
Spain
State/province [61] 0 0
Sevilla
Country [62] 0 0
Spain
State/province [62] 0 0
Terrassa
Country [63] 0 0
Spain
State/province [63] 0 0
Valencia
Country [64] 0 0
Spain
State/province [64] 0 0
Vigo Pontevedra
Country [65] 0 0
Spain
State/province [65] 0 0
Zaragoza
Country [66] 0 0
Sweden
State/province [66] 0 0
Stockholm
Country [67] 0 0
Switzerland
State/province [67] 0 0
Bruderholz
Country [68] 0 0
Switzerland
State/province [68] 0 0
Zurich
Country [69] 0 0
Turkey
State/province [69] 0 0
Ankara
Country [70] 0 0
United Kingdom
State/province [70] 0 0
England
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Northern Ireland
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Scotland
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Other
Name
EBMT Solid Tumors Working Party
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lymphoma Trials Office
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00005589
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ruth Pettengell, MD
Address 0 0
St George's, University of London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00005589