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

Lymphoma, Follicular Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930514
• Other study ID #: BP22333
• Secondary ID: 2008-008490-60
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2009
• Last updated: November 1, 2016
• Start date: September 2009
• Est. completion date: July 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ecuador: Public Health Ministry
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Rituximab
Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.
• Rituximab
Rituximab subcutaneous injection at 800 mg/m^2 dose level, administered every 2 or 3 months.
• Rituximab
Rituximab subcutaneous injection 625 mg/m^2 administered every 2 or 3 months.
• Rituximab
Rituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months.
• Rituximab
Rituximab subcutaneous injection 375 mg/m^2 administered every 2 or 3 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum Observed Plasma Trough Concentration (C trough)		Up to 29 months	No
Secondary	Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau)		Up to 29 months	No
Secondary	Maximum Observed Plasma Concentration (Cmax)		Up to 29 months	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Up to 29 months	No
Secondary	Plasma Decay Half-Life (t1/2)		Up to 29 months	No
Secondary	Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)		Up to 29 months	No