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An Open-label Study of the Effect of the Addition of MabThera to Standard Chemotherapy on Clinical Response in Patients With Previously Untreated Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Mantle Cell Lymphoma

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Trial Information

An Open-label Study of the Effect of the Addition of MabThera to Standard Chemotherapy on Clinical Response in Patients With Previously Untreated Mantle Cell Lymphoma


Inclusion Criteria:



- histologically-proven mantle cell lymphoma;

- previously untreated disease at stage II, III and IV, requiring therapy.

Exclusion Criteria:

- known hypersensitivity reaction to rituximab, or known anti-murine antibody
reactivity or known hypersensitivity to murine antibodies;

- active malignancy other than mantle cell lymphoma within 5 years of start of study,
with the exception of resected basal cell cancer, squamous cell cancer of the skin,
or in situ cancer of the cervix;

- serious disorders interfering with full standard dosing chemotherapy;

- stage I disease.

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:

Complete and partial response

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Hungary: Ministry of Health

Study ID:

ML20493

NCT ID:

NCT00472420

Start Date:

June 2007

Completion Date:

March 2014

Related Keywords:

  • Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

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