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A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00930514
Collaborator
(none)
281
Enrollment
62
Locations
6
Arms
46
Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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/m2) intravenously, 375 mg/m2 subcutaneously or 625 mg/m2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the subcutaneous dose (800 mg/m2) 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
281 participants
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Rituximab IV 375 mg/m^2 (Stage 1: Cohort A)

Drug: Rituximab
Rituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months.
Other Names:
  • MabThera/Rituxan

    		•
    Active Comparator: Rituximab IV 375 mg/m^2 (Stage 2: Cohort E)

    Drug: Rituximab
    Rituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months.
    Other Names:
  • MabThera/Rituxan

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

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

    Drug: Rituximab
    Rituximab subcutaneous injection at 800 mg/m^2 dose level, administered every 2 or 3 months.
    Other Names:
  • MabThera/Rituxan

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

    Drug: Rituximab
    Rituximab subcutaneous injection 375 mg/m^2 administered every 2 or 3 months.
    Other Names:
  • MabThera/Rituxan

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

    Drug: Rituximab
    Rituximab subcutaneous injection 625 mg/m^2 administered every 2 or 3 months.
    Other Names:
  • MabThera/Rituxan

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

    Drug: Rituximab
    Rituximab subcutaneous injection at 800 mg/m^2 dose level, administered every 2 or 3 months.
    Other Names:
  • MabThera/Rituxan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Minimum Observed Plasma Trough Concentration (C trough) [Up to 29 months]

    Secondary Outcome Measures

    1. Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau) [Up to 29 months]

    2. Maximum Observed Plasma Concentration (Cmax) [Up to 29 months]

    3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [Up to 29 months]

    4. Plasma Decay Half-Life (t1/2) [Up to 29 months]

    5. Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [Up to 29 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Buenos Aires Argentina 1425
    2 Buenos Aires Argentina C1114AAN
    3 Buenos Aires Argentina C1221ADC
    4 Córdoba Argentina 5000
    5 Rosario Argentina 2000
    6 Kogarah New South Wales Australia 2217
    7 Sydney New South Wales Australia 2139
    8 Kurralta Park South Australia Australia 5037
    9 Fitzroy Victoria Australia 3065
    10 Porto Alegre RS Brazil 91350-200
    11 Barretos SP Brazil 14784-400
    12 Sao Paulo SP Brazil 05403-000
    13 Sao Paulo SP Brazil 05652-000
    14 Calgary Alberta Canada T2N 4N2
    15 St. John's Newfoundland and Labrador Canada A1B 3V6
    16 Halifax Nova Scotia Canada B3H 2Y9
    17 Montreal Quebec Canada H3T 1E2
    18 Quebec Canada G1J 1Z4
    19 Brno Czech Republic 625 00
    20 Hradec Kralove Czech Republic 500 05
    21 Praha 2 Czech Republic 128 08
    22 Herlev Denmark 2730
    23 Guayaquil Ecuador EC090114
    24 Quito Ecuador 2569
    25 Helsinki Finland 00029
    26 Tampere Finland 33520
    27 Turku Finland 20520
    28 Marseille France 13273
    29 Montpellier France 34295
    30 Reims France 51092
    31 Haifa Israel 3109601
    32 Jerusalem Israel 9112001
    33 Petach Tikva Israel 49100
    34 Ramat Gan Israel 52662
    35 Bergamo Lombardia Italy 24127
    36 Milano Lombardia Italy 20162
    37 Torino Piemonte Italy 10126
    38 Pisa Toscana Italy 56100
    39 Seoul Korea, Republic of 135-710
    40 Aguascalientes Mexico 20127
    41 Mexico City, Distrito Federal Mexico 14050
    42 Monterrey Mexico 64460
    43 Oslo Norway 0379
    44 Lima Peru 11
    45 Lima Peru 34
    46 Warszawa Poland 02 776
    47 Wroclaw Poland 50-367
    48 Moscow Russian Federation 115478
    49 Bratislava Slovakia 833 10
    50 Barcelona Spain 08003
    51 Barcelona Spain 08036
    52 Salamanca Spain 37007
    53 Sevilla Spain 41013
    54 Huddinge Sweden 14186
    55 Sundsvall Sweden 85186
    56 Umea Sweden 90185
    57 Uppsala Sweden 75185
    58 Basel Switzerland 4031
    59 Cambridge United Kingdom CB2 0QQ
    60 London United Kingdom EC1A 7BE
    61 Manchester United Kingdom M20 4QL
    62 Nottingham United Kingdom NG5 1PB

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT00930514
    Other Study ID Numbers:
    • BP22333
    • 2008-008490-60
    First Posted:
    Jun 30, 2009
    Last Update Posted:
    Nov 2, 2016
    Last Verified:
    Nov 1, 2016
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular
    Rituximab

    Study Results

    No Results Posted as of Nov 2, 2016