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A Two-stage Phase III, International, Multi-center, Randomized, Controlled, Open-label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

A Two-stage Phase III, International, Multi-center, Randomized, Controlled, Open-label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV


Inclusion Criteria:



- Adult patients, >/=18 years of age

- CD20-positive, follicular Non-Hodgkin's lymphoma grade 1, 2, 3a. A tumor biopsy must
have been performed within 6 months before study entry with material available for
central review.

- No prior treatment

- ECOG performance status 0-2

Exclusion Criteria:

- Grade 3b follicular lymphoma

- Transformation to high-grade lymphoma secondary to follicular lymphoma

- Types of Non-Hodgkin's lymphoma other than follicular lymphoma

- Presence or history of CNS disease

- Corticoid therapy during the last 4 weeks, except prednisone treatment <20 mg per day

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Stage I: To estimate the ratio of trough serum concentrations of MabThera after subcutaneous administration to that obtained after intravenous administration

Outcome Time Frame:

Day 21

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

To: be added

Study ID:

BO22334

NCT ID:

NCT01200758

Start Date:

February 2011

Completion Date:

April 2019

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

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