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

First listed
Dec 2, 2013
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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