A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabTher... | Not Recruiting
A Study of Rituximab (MabThera) Sub... | Not Recruiting
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous (IV) in Participants With Follicular Non-Hodgkin's Lymphoma

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Medical Conditions
  • Non-Hodgkin's Lymphoma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT01200758

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Summary
This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Rituximab SC, Drug : Rituximab IV, Drug : Cyclophosphamide, Drug : Doxorubicin, Drug : Vincristine, Drug : Prednisone/Prednisolone

Study Arm Groups : Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP), Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP), Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP), Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP), Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP), Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP), Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP), Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP), Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP), Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP), Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)

Intervention Type
See Interventions above
Primary Outcome Measures
    Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab; Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours [hrs] predose on Cy 8) of induction treatment (1 Cy=3 weeks); Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment; Stage II: Baseline up to end of induction treatment Cy 8 (24 weeks) (1 Cy=3 weeks); Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment; Stage I and II: Baseline up to end of induction treatment Cy 8 (24 weeks) (1 Cy=3 weeks)
Secondary Outcome Measures
    Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment; Stage I: Baseline up to end of induction treatment Cy 8 (24 weeks) (1 Cy=3 weeks); Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment; Stage I: Baseline up to end of induction treatment Cy 8 (24 weeks) (1 Cy=3 weeks); Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment; Stage II: Baseline up to end of induction treatment Cy 8 (24 weeks) (1 Cy=3 weeks); Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment; Stage I and II: Baseline up to end of induction treatment Cy 8 (24 weeks) (1 Cy=3 weeks); Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment; Stage I and Stage II: Baseline up to 78 days after last maintenance dose (last maintenance dose: maintenance Cy 12/Study Cy 20 [30 months] [1 Cy=8 weeks]); Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment; Stage I and II: Baseline up to 78 days after last maintenance dose (last maintenance dose: maintenance Cy 12/Study Cy 20 [30 months] [1 Cy=8 weeks]); Stage 1 and II (Pooled): Progression-Free Survival (PFS); Baseline, D1 of all cycles (Cy 1-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months;up to data cutoff of 3 February 2014 [up to 4 years]); Percentage of Participants With Disease Progression or Death; Baseline, D1 of all cycles (Cy 1-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 3 February 2014 [up to 4 years]); Stage I and II (Pooled): Event-Free Survival; Baseline until documented disease progression/relapse or death (up to study completion [up to approximately 105 months]); Stage I and II (Pooled): Median Time to Overall Survival (OS); Baseline until documented disease progression/relapse or death (up to study completion [up to approximately 105 months]); Stage 1: Observed Area Under the Serum Concentration-Time Curve (AUC) of IV and SC Rituximab at Cycle 7; Stage I (Induction): predose (0 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion on Cy 7 D1 for rituximab IV (up to data cutoff of 11 April 2012 [up to 26 months]); Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab at Cycle 7; Stage I (Induction): predose (0 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion on Cy 7 D1 for rituximab IV (up to data cutoff of 11 April 2012 [up to 26 months]); Stage I and II (Pooled): Trough Serum Concentrations (Ctrough) of Rituximab at Each Induction Treatment Cycle; Stage I and II (induction): rituximab IV - predose (0 hr) on D1 of Cy 1 to 8 (1 Cy=3 weeks and 4 weeks for Cy8); rituximab SC - predose (0 hr) on D1 of Cy 1 and Cy 3 to 8, predose (0 hr) on D0 of Cy2 (up to data cutoff of 3 February 2014 [up to 4 years]); Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle; Stage I and II (maintenance): D29 of Cy 8 (induction; 1Cy=4 weeks), predose (0 hr) on D1 of Cy 9 to 19 (maintenance Cycle 1 to 12 [1 Cy=8 weeks]; up to data cutoff of 3 February 2014 [up to 4 years]); Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration; 12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (median treatment duration: 383.5 days for IV dose and 406 days for SC dose; up to data cutoff of 3 February 2014 [up to 4 years]); Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase; Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2, thereafter at follow-up visits every 12 weeks after the last rituximab administration until 72 weeks; Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase; Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 3 February 2014 [up to 4 years]); Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs); Baseline, Post-Baseline (Cy 1 D1 [induction] up to follow-up [1 Cy=3 weeks]) (a median of 27 months; up to data cutoff of 3 February 2014 [up to 4 years]); Stage I and II (Pooled): Percentage of Participants Who Saved Time of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20; Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks); after 48 weeks of maintenance treatment (after Cy15) and after the end of the maintenance treatment (after Cy20) (up to data cutoff of 3 February 2014 [up to 4 year]); Stage I and II (Pooled): Percentage of Participants With Preferred Rituximab SC Formulations as Compared to IV Formulation as Assessed by Physician/Nurse at the End of Cy 8, 15, and 20; Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1Cy=3 weeks); after 48 weeks of maintenance treatment (after Cy15) and after the end of the maintenance treatment (after Cy20) (up to data cutoff of 3 February 2014 [up to 4 years])
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Cluster of differentiation 20 (CD20)-positive, follicular Non-Hodgkin's lymphoma grade 1, 2, 3a. A tumor biopsy must have been performed within 6 months before study entry with material available for central review.

    - No prior treatment

    - Eastern Cooperative Oncology Group (ECOG) performance status 0-2

    Exclusion Criteria:

    - Grade 3b follicular lymphoma

    - Transformation to high-grade lymphoma secondary to follicular lymphoma

    - Types of Non-Hodgkin's lymphoma other than follicular lymphoma

    - Presence or history of central nervous system (CNS) disease

    - Corticoid therapy during the last 4 weeks, except prednisone treatment less than (<) 20 milligrams per day (mg per day)

    - Known active bacterial, viral, fungal, or mycobacterial, or any major episode of infections requiring hospitalization or treatment with IV antibiotics within 4 weeks of start of study medication, or oral antibiotics within 2 weeks prior to start of study medication
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Maidstone Hospital
Maidstone
England
ME16 9QQ
Southampton General Hospital
Southampton
England
SO16 6YD
Plymouth
PL6 8DH
Novartis Investigative Site
Wolverhampton
WV10 0QP
Dundee
DD1 9SY
Romford
Essex
RM7 0AG
Pinderfields General Hospital
Wakefield
Scotland
WF1 4DG
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Denmark, Finland, France, Georgia, Germany, Greece, Italy, Macedonia, The Former Yugoslav Republic of, Malaysia, Mexico, New Zealand, Peru, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Thailand, Turkey, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
BO22334
Sponsor(s)
Hoffmann-La Roche
Key Dates

Recruitment Start Date

Feb 2011

Recruitment End Date

Jun 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

10 Sep 2010

Date updated in source

23 Jan 2017