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

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ClinicalTrials.gov Identifier: NCT00930514
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphoma, Follicular Drug: Rituximab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: MabThera/Rituxan


Outcome Measures
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Primary Outcome Measures :
  1. Minimum Observed Plasma Trough Concentration (C trough) [ Time Frame: Up to 29 months ]

Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau) [ Time Frame: Up to 29 months ]
  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to 29 months ]
  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Up to 29 months ]
  4. Plasma Decay Half-Life (t1/2) [ Time Frame: Up to 29 months ]
  5. Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Up to 29 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930514


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00930514    
Other Study ID Numbers: BP22333
2008-008490-60
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Rituximab
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents