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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00930514
Ethics application status
Date submitted
16/06/2009
Date registered
29/06/2009
Date last updated
1/11/2016

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
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
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) -

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.

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
Primary outcome [2] 0 0
Minimum Observed Plasma Trough Concentration (C trough)
Timepoint [2] 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
Secondary outcome [6] 0 0
Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau)
Timepoint [6] 0 0
Up to 29 months
Secondary outcome [7] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [7] 0 0
Up to 29 months
Secondary outcome [8] 0 0
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Timepoint [8] 0 0
Up to 29 months
Secondary outcome [9] 0 0
Plasma Decay Half-Life (t1/2)
Timepoint [9] 0 0
Up to 29 months
Secondary outcome [10] 0 0
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Timepoint [10] 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and
intravenous rituximab in participants with follicular lymphoma. In the first stage,
participants who have achieved at least a partial response after induction treatment with
intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab
375 milligram per square meter (mg/m^2) intravenously, 375 mg/m^2 subcutaneously or 625
mg/m^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of
the subcutaneous dose (800 mg/m^2) which results in rituximab trough plasma concentration (C
trough) values comparable to those achieved with the intravenous formulation, participants in
the second stage of the study will be randomized to receive either the subcutaneous or
intravenous formulation to demonstrate comparability of the C trough levels with both routes
of administration. Maintenance therapy will continue every 2 or 3 months with the
subcutaneous formulation.
Trial website
https://clinicaltrials.gov/show/NCT00930514
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

Summary results
Other publications