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A Two Stage Phase Ib Study to Investigate the Pharmocokinetics and Tolerability of Rituximab Subcutaneous Formulation in Pats With Follicular Lymphoma as Part of Maintenance Treatement.


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Follicular

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Trial Information

A Two Stage Phase Ib Study to Investigate the Pharmocokinetics and Tolerability of Rituximab Subcutaneous Formulation in Pats With Follicular Lymphoma as Part of Maintenance Treatement.


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

C trough

Outcome Time Frame:

At intervals up to day 84

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Ecuador: Public Health Ministry

Study ID:

BP22333

NCT ID:

NCT00930514

Start Date:

September 2009

Completion Date:

June 2013

Related Keywords:

  • Lymphoma, Follicular
  • Lymphoma
  • Lymphoma, Follicular

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