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An Open-label Study of Fludarabine and Cyclophosphamide Plus MabThera Followed by Maintenance With MabThera on Failure-free Survival in Treatment-naïve Patients With Advanced Indolent B-cell Nonfollicular Lymphoma


Phase 2
18 Years
65 Years
Not Enrolling
Both
Non-Hodgkin's Lymphoma

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Trial Information

An Open-label Study of Fludarabine and Cyclophosphamide Plus MabThera Followed by Maintenance With MabThera on Failure-free Survival in Treatment-naïve Patients With Advanced Indolent B-cell Nonfollicular Lymphoma


Inclusion Criteria:



- adult patients 18-65 years of age;

- previously untreated indolent nonfollicular non-Hodgkin's lymphoma;

- active disease;

- >=3 involved sites.

Exclusion Criteria:

- typical chronic lymphocytic leukemia;

- other malignancies within 3 years before study, except basal or squamous cell skin
cancer or cancer in situ of the cervix;

- systemic corticosteroid use for >1 month;

- significant cardiovascular disease;

- central nervous system involvement;

- hepatitis B or C virus infection, or HIV infection.

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:

Failure-free survival

Outcome Time Frame:

From first patient enrolled to approximately 42 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Chair

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: Ministry of Health

Study ID:

ML18324

NCT ID:

NCT01153971

Start Date:

July 2005

Completion Date:

September 2010

Related Keywords:

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

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