Lymphoma, FollicularPhase 1NCT00930514
A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma
A Phase 1 study testing Rituximab in people with Lymphoma, Follicular, run by Hoffmann-La Roche at 62 sites in 22 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Follicular
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 62 sitesin 22 countries
- Study dates
- Sep 2009to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
62 sites in 22 countries.
62 sites in 22 countries
Argentina5 sites
Study site
Buenos Aires, 1425
Study site
Buenos Aires, C1114AAN
Study site
Buenos Aires, C1221ADC
Study site
Córdoba, 5000
Study site
Rosario, 2000
Canada5 sites
Study site
Calgary, Alberta, T2N 4N2
Study site
Halifax, Nova Scotia, B3H 2Y9
Study site
Montreal, Quebec, H3T 1E2
Study site
Québec, Quebec, G1J 1Z4
Study site
St. John's, Newfoundland and Labrador, A1B 3V6
Australia4 sites
Study site
Fitzroy, Victoria, 3065
Study site
Kogarah, New South Wales, 2217
Study site
Kurralta Park, South Australia, 5037
Study site
Sydney, New South Wales, 2139
Brazil4 sites
Study site
Barretos, São Paulo, 14784-400
Study site
Porto Alegre, Rio Grande do Sul, 91350-200
Study site
São Paulo, São Paulo, 05403-000
Study site
São Paulo, São Paulo, 05652-000
Israel4 sites
Study site
Haifa, 3109601
Study site
Jerusalem, 9112001
Study site
Petah Tikva, 49100
Study site
Ramat Gan, 52662
Italy4 sites
Study site
Bergamo, Lombardy, 24127
Study site
Milan, Lombardy, 20162
Study site
Pisa, Tuscany, 56100
Study site
Turin, Piedmont, 10126
Spain4 sites
Study site
Barcelona, Barcelona, 08003
Study site
Barcelona, Barcelona, 08036
Study site
Salamanca, Salamanca, 37007
Study site
Seville, Sevilla, 41013
Sweden4 sites
Study site
Huddinge, 14186
Study site
Sundsvall, 85186
Study site
Umeå, 90185
Study site
Uppsala, 75185
United Kingdom4 sites
Study site
Cambridge, CB2 0QQ
Study site
London, EC1A 7BE
Study site
Manchester, M20 4QL
Study site
Nottingham, NG5 1PB
Czechia3 sites
Study site
Brno, 625 00
Study site
Hradec Králové, 500 05
Study site
Prague, 128 08
Finland3 sites
Study site
Helsinki, 00029
Study site
Tampere, 33520
Study site
Turku, 20520
France3 sites
Study site
Marseille, 13273
Study site
Montpellier, 34295
Study site
Reims, 51092
Mexico3 sites
Study site
Aguascalientes, 20127
Study site
Mexico City, Distrito Federal, 14050
Study site
Monterrey, 64460
About this study
Official 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
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.
- Conditions
- Lymphoma, Follicular
- Being tested
- Rituximab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.
RituximabDrug
Also called MabThera/Rituxan
Rituximab subcutaneous injection at 800 mg/m^2 dose level, administered every 2 or 3 months.
RituximabDrug
Also called MabThera/Rituxan
Rituximab subcutaneous injection 625 mg/m^2 administered every 2 or 3 months.
RituximabDrug
Also called MabThera/Rituxan
Rituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months.
RituximabDrug
Also called MabThera/Rituxan
Rituximab subcutaneous injection 375 mg/m^2 administered every 2 or 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab IV 375 mg/m^2 (Stage 1: Cohort A) | Active comparator | Not described Receives: Drug: Rituximab |
| Rituximab IV 375 mg/m^2 (Stage 2: Cohort E) | Active comparator | Not described Receives: Drug: Rituximab |
| Rituximab SC 1400 mg (Stage 2: Cohort F) | Experimental | Not described Receives: Drug: Rituximab |
| Rituximab SC 375 mg/m^2 (Stage 1: Cohort B) | Experimental | Not described Receives: Drug: Rituximab |
| Rituximab SC 625 mg/m^2 (Stage 1: Cohort C) | Experimental | Not described Receives: Drug: Rituximab |
| Rituximab SC 800 mg/m^2 (Stage 1: Cohort D) | Experimental | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Observed Plasma Trough Concentration (C trough)
Measured: Up to 29 months
Secondary outcomes (5)
Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau)
Measured: Up to 29 months
Maximum Observed Plasma Concentration (Cmax)
Measured: Up to 29 months
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Up to 29 months
Plasma Decay Half-Life (t1/2)
Measured: Up to 29 months
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Measured: Up to 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, FollicularStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930514
- Sponsor's protocol ID
- BP22333
- Other IDs
- 2008-008490-60, 2008
- Status last verified
- Nov 2016
- First submitted
- 16 Jun 2009
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Salar A, Avivi I, Bittner B, Bouabdallah R, Brewster M, Catalani O, Follows G, Haynes A, Hourcade-Potelleret F, Janikova A, Larouche JF, McIntyre C, Pedersen M, Pereira J, Sayyed P, Shpilberg O, Tumyan G. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 2014 Jun 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631. Epub 2014 May 12.
PubMed 24821885Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.
PubMed 24265828
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00930514
- Acronym / sponsor ID
- BP22333
- Conditions
- Lymphoma, Follicular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Rituximab IV 375 mg/m^2 (Stage 1: Cohort A) | Active comparator | Drug: Rituximab |
| Rituximab IV 375 mg/m^2 (Stage 2: Cohort E) | Active comparator | Drug: Rituximab |
| Rituximab SC 1400 mg (Stage 2: Cohort F) | Experimental | Drug: Rituximab |
| Rituximab SC 375 mg/m^2 (Stage 1: Cohort B) | Experimental | Drug: Rituximab |
| Rituximab SC 625 mg/m^2 (Stage 1: Cohort C) | Experimental | Drug: Rituximab |
| Rituximab SC 800 mg/m^2 (Stage 1: Cohort D) | Experimental | Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabRituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months. | Drug | Rituximab SC 1400 mg (Stage 2: Cohort F) |
| RituximabAlso: MabThera/RituxanRituximab subcutaneous injection at 800 mg/m^2 dose level, administered every 2 or 3 months. | Drug | Rituximab SC 1400 mg (Stage 2: Cohort F), Rituximab SC 800 mg/m^2 (Stage 1: Cohort D) |
| RituximabAlso: MabThera/RituxanRituximab subcutaneous injection 625 mg/m^2 administered every 2 or 3 months. | Drug | Rituximab SC 625 mg/m^2 (Stage 1: Cohort C) |
| RituximabAlso: MabThera/RituxanRituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months. | Drug | Rituximab IV 375 mg/m^2 (Stage 1: Cohort A), Rituximab IV 375 mg/m^2 (Stage 2: Cohort E) |
| RituximabAlso: MabThera/RituxanRituximab subcutaneous injection 375 mg/m^2 administered every 2 or 3 months. | Drug | Rituximab SC 375 mg/m^2 (Stage 1: Cohort B) |
Primary outcome
Minimum Observed Plasma Trough Concentration (C trough)
Time frame: Up to 29 months
5 secondary outcomes
Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau)
Time frame: Up to 29 months
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 29 months
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to 29 months
Plasma Decay Half-Life (t1/2)
Time frame: Up to 29 months
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Up to 29 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 24821885Salar A, Avivi I, Bittner B, Bouabdallah R, Brewster M, Catalani O, Follows G, Haynes A, Hourcade-Potelleret F, Janikova A, Larouche JF, McIntyre C, Pedersen M, Pereira J, Sayyed P, Shpilberg O, Tumyan G. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 2014 Jun 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631. Epub 2014 May 12.
- Derived from this study: PubMed 24265828Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
62 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rituximab in people with Lymphoma, Follicular, run by Hoffmann-La Roche at 62 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Argentina, Canada, Australia, Brazil, Israel and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Observed Plasma Trough Concentration (C trough) (time frame: Up to 29 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00930514, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.