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A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy.


Phase 4
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

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Trial Information

A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy.


Inclusion Criteria:



- adult patients, >=18 years of age;

- histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;

- patients who have received adequate (>=8 cycles) induction therapy with MabThera as
first line treatment, or treatment for relapsed disease;

- demonstrated partial or complete response to induction therapy.

Exclusion Criteria:

- stable or progressive disease after most recent induction therapy;

- transformation to high grade lymphoma;

- patients with prior or concomitant malignancies, except non-melanoma skin cancer or
adequately treated in situ cancer of the cervix.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of all, and of grade 3/4, adverse events.

Outcome Time Frame:

Throughout study

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: Ministry of Health

Study ID:

MO19872

NCT ID:

NCT00430352

Start Date:

September 2006

Completion Date:

September 2012

Related Keywords:

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

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