A Pharmacokinetic Study of Subcutaneous and Intravenous MabThera (Rituximab) in Patients With Follicular Lymphoma
Tracking Information| Start Date ICMJE | September 2009 |
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| Primary Completion Date | |
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Current Primary Outcome Measures ICMJE
(submitted: June 29, 2009) | C trough [ Time Frame: At intervals up to day 84 ] [ Designated as safety issue: No ] |
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| Original Primary Outcome Measures ICMJE | Same as current |
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| Change History | Complete list of historical versions of study NCT00930514 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE
(submitted: June 29, 2009) | - AUC 0-last, Cmax, tmax, t1/2 [ Time Frame: At intervals up to day 84 ] [ Designated as safety issue: No ]
- Adverse events, laboratory parameters [ Time Frame: Throughout study, at each clinic visit ] [ Designated as safety issue: No ]
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| Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive Information| Brief Title ICMJE | A Pharmacokinetic Study of Subcutaneous and Intravenous MabThera (Rituximab) in Patients With Follicular Lymphoma |
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| Official Title ICMJE | A Two Stage Phase Ib Study to Investigate the Pharmacokinetics and Tolerability of Rituximab Subcutaneous Formulation in Pats With Follicular Lymphoma as Part of Maintenance Treatment. |
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| Brief Summary | This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous MabThera (rituximab) in patients with follicular lymphoma.In the first stage, patients who have achieved at least a partial response after induction treatment with iv MabThera will be randomized to one of 3 treatment cohorts, to receive MabThera 375mg/m2 iv, 375mg/m2 sc or 625mg/m2 sc, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the sc dose which results in rituximab C trough values comparable to those achieved with the iv formulation, patients in the second stage of the study will be randomized to receive either the sc or iv 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 sc formulation. The anticipated time on study treatment is up to 31 months for an individual patient, and the target sample size is 215-250 individuals. |
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| Detailed Description | |
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| Study Phase | Phase I |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
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| Condition ICMJE | Follicular Lymphoma |
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| Intervention ICMJE | |
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| Study Arms / Comparison Groups | - Cohort 1 (Part 1): Active Comparator
Intervention: Drug: rituximab [MabThera/Rituxan] - Cohort 2 (Part 1): Experimental
Intervention: Drug: rituximab [MabThera/Rituxan] - Cohort 3 (Part 1): Experimental
Intervention: Drug: rituximab [MabThera/Rituxan] - Cohort 1 (Part 2): Active Comparator
Intervention: Drug: rituximab [MabThera/Rituxan] - Cohort 2 (Part 2): Experimental
Intervention: Drug: rituximab [MabThera/Rituxan]
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Recruitment Information| Estimated Enrollment ICMJE | 245 |
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| Estimated Completion Date | May 2014 |
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| Primary Completion Date | |
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| Eligibility Criteria ICMJE | Inclusion Criteria: - adult patients, >=18 years of age;
- CD20-positive follicular non-Hodgkin's lymphoma (NHL);
- partial or complete response a the end of induction treatment with MabThera;
- must have completed induction treatment, and received >= 1 dose of iv MabThera maintenance treatment;
- ECOG performance status of <=2.
Exclusion Criteria: - histological evidence of transformation of NHL, or types of NHL other han follicular lymphoma;
- presence or history of CNS disease;
- history of malignancy other than follicular NHL which could affect compliance with protocol or interpretation of results;
- recent major surgery (within 4 weeks prior to screening, excluding lymph node biopsy).
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| Gender | Both |
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| Ages | 18 Years and older |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | |
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| Location Countries ICMJE | Argentina, Australia, Brazil, Canada, Czech Republic, Denmark, Ecuador, Finland, France, Israel, Italy, Korea, Republic of, Mexico, Norway, Peru, Poland, Russian Federation, Slovakia, Spain, Sweden, Switzerland, United Kingdom |
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Administrative Information| NCT ID ICMJE | NCT00930514 |
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| Responsible Party | Disclosures Group, Hoffmann-La Roche |
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| Study ID Numbers ICMJE | BP22333, 2008-008490-60 |
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| Study Sponsor ICMJE | Hoffmann-La Roche |
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| Collaborators ICMJE | |
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| Investigators ICMJE | | Study Director: | Clinical Trials | Hoffmann-La Roche | |
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| Information Provided By | Hoffmann-La Roche |
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