A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma

Sponsor
Hoffmann-La Roche
Study ID
NCT01998893
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab [MabThera/Rituxan] — DRUG
    375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse

Study Details

This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is \<3 months.

Key Dates

Start date
Jan 31, 1997
Status verified
Oct 2014
Primary completion
Feb 29, 2008
Completion
Feb 29, 2008

Study Design

Enrollment
38 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MabThera/Rituxan

Primary Outcome Measure

Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR) [ Time Frame: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months) ]

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