Skip to main content
OpenTrials
Completed

NCT Number: NCT00930514

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphoma, Follicular Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.

Primary outcomes

  1. Minimum Observed Plasma Trough Concentration (C trough)

    Time frame: Up to 29 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 30, 2009
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.