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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00930514




Registration number
NCT00930514
Ethics application status
Date submitted
16/06/2009
Date registered
30/06/2009
Date last updated
2/11/2016

Titles & IDs
Public title
A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma
Scientific title
A Two Stage Phase Ib Study to Investigate the Pharmacokinetics, Safety and Tolerability of Rituximab Subcutaneous (SC) Formulation in Patients With Follicular Lymphoma (FL) as Part of Maintenance Treatment
Secondary ID [1] 0 0
2008-008490-60
Secondary ID [2] 0 0
BP22333
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Follicular 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
Treatment: Drugs - Rituximab
Treatment: Drugs - Rituximab
Treatment: Drugs - Rituximab
Treatment: Drugs - Rituximab
Treatment: Drugs - Rituximab

Active comparator: Rituximab IV 375 mg/m^2 (Stage 1: Cohort A) -

Active comparator: Rituximab IV 375 mg/m^2 (Stage 2: Cohort E) -

Experimental: Rituximab SC 1400 mg (Stage 2: Cohort F) -

Experimental: Rituximab SC 375 mg/m^2 (Stage 1: Cohort B) -

Experimental: Rituximab SC 625 mg/m^2 (Stage 1: Cohort C) -

Experimental: Rituximab SC 800 mg/m^2 (Stage 1: Cohort D) -


Treatment: Drugs: Rituximab
Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.

Treatment: Drugs: Rituximab
Rituximab subcutaneous injection at 800 mg/m\^2 dose level, administered every 2 or 3 months.

Treatment: Drugs: Rituximab
Rituximab subcutaneous injection 625 mg/m\^2 administered every 2 or 3 months.

Treatment: Drugs: Rituximab
Rituximab intravenous infusion 375 milligram per square meter (mg/m\^2) administered every 2 or 3 months.

Treatment: Drugs: Rituximab
Rituximab subcutaneous injection 375 mg/m\^2 administered every 2 or 3 months.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Minimum Observed Plasma Trough Concentration (C trough)
Timepoint [1] 0 0
Up to 29 months
Secondary outcome [1] 0 0
Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau)
Timepoint [1] 0 0
Up to 29 months
Secondary outcome [2] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [2] 0 0
Up to 29 months
Secondary outcome [3] 0 0
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Timepoint [3] 0 0
Up to 29 months
Secondary outcome [4] 0 0
Plasma Decay Half-Life (t1/2)
Timepoint [4] 0 0
Up to 29 months
Secondary outcome [5] 0 0
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Timepoint [5] 0 0
Up to 29 months

Eligibility
Key inclusion criteria
* CD20-positive follicular non-Hodgkin's lymphoma (NHL)
* Documented partial or complete response a the end of induction treatment with rituximab
* Must have completed induction treatment, and received at least 1 dose of intravenous rituximab maintenance treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of less than and equal to (<=) 2
* Life expectancy of greater than and equal to (>=) 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma
* Presence or history of central nervous system disease
* History of malignancy other than follicular NHL
* Recent major surgery (within 4 weeks prior to screening), excluding lymph node biopsy

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Parallel
Other design features
Phase
Phase 1
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
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
281
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- Kogarah
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Kurralta Park
Recruitment hospital [4] 0 0
- Fitzroy
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2139 - Sydney
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Córdoba
Country [3] 0 0
Argentina
State/province [3] 0 0
Rosario
Country [4] 0 0
Brazil
State/province [4] 0 0
RS
Country [5] 0 0
Brazil
State/province [5] 0 0
SP
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Newfoundland and Labrador
Country [8] 0 0
Canada
State/province [8] 0 0
Nova Scotia
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Brno
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Hradec Kralove
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Praha 2
Country [13] 0 0
Denmark
State/province [13] 0 0
Herlev
Country [14] 0 0
Ecuador
State/province [14] 0 0
Guayaquil
Country [15] 0 0
Ecuador
State/province [15] 0 0
Quito
Country [16] 0 0
Finland
State/province [16] 0 0
Helsinki
Country [17] 0 0
Finland
State/province [17] 0 0
Tampere
Country [18] 0 0
Finland
State/province [18] 0 0
Turku
Country [19] 0 0
France
State/province [19] 0 0
Marseille
Country [20] 0 0
France
State/province [20] 0 0
Montpellier
Country [21] 0 0
France
State/province [21] 0 0
Reims
Country [22] 0 0
Israel
State/province [22] 0 0
Haifa
Country [23] 0 0
Israel
State/province [23] 0 0
Jerusalem
Country [24] 0 0
Israel
State/province [24] 0 0
Petach Tikva
Country [25] 0 0
Israel
State/province [25] 0 0
Ramat Gan
Country [26] 0 0
Italy
State/province [26] 0 0
Lombardia
Country [27] 0 0
Italy
State/province [27] 0 0
Piemonte
Country [28] 0 0
Italy
State/province [28] 0 0
Toscana
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Mexico
State/province [30] 0 0
Aguascalientes
Country [31] 0 0
Mexico
State/province [31] 0 0
Mexico City, Distrito Federal
Country [32] 0 0
Mexico
State/province [32] 0 0
Monterrey
Country [33] 0 0
Norway
State/province [33] 0 0
Oslo
Country [34] 0 0
Peru
State/province [34] 0 0
Lima
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Poland
State/province [36] 0 0
Wroclaw
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Moscow
Country [38] 0 0
Slovakia
State/province [38] 0 0
Bratislava
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Salamanca
Country [41] 0 0
Spain
State/province [41] 0 0
Sevilla
Country [42] 0 0
Sweden
State/province [42] 0 0
Huddinge
Country [43] 0 0
Sweden
State/province [43] 0 0
Sundsvall
Country [44] 0 0
Sweden
State/province [44] 0 0
Umea
Country [45] 0 0
Sweden
State/province [45] 0 0
Uppsala
Country [46] 0 0
Switzerland
State/province [46] 0 0
Basel
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Cambridge
Country [48] 0 0
United Kingdom
State/province [48] 0 0
London
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Manchester
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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

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/NCT00930514