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

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 |
- Minimum Observed Plasma Trough Concentration (C trough) [ Time Frame: Up to 29 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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

Study Director: | Clinical Trials | Hoffmann-La Roche |
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 |
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 |