Clinical trial NCT01998893: A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma
Official title: Clinical Response in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma After Treatment With Anti-CD20 Antibody IDEC C2B8 (MabThera)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* adult patients \>= 18 years of age;
* centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
* relapse after chemotherapy (with or without interferon maintenance therapy).

Exclusion Criteria:

* primary refractory lymphomas;
* more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
* clinically significant cardiac disease.

Primary outcomes:
measure: Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)
timeFrame: 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)
Secondary outcomes:
measure: Number of Participants With a Clinical Response
timeFrame: 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)
measure: Time to Best Response
timeFrame: 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)
measure: Duration of Remission
timeFrame: 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)
measure: Time to Progression
timeFrame: 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)
measure: Overall Survival (OS)
timeFrame: Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)
measure: Number of Participants With a Clinical Response to Re-Treatment
timeFrame: First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).
Other outcomes:
Locations:
city: Erlangen
country: Germany
city: Grenzach-wyhlen
country: Germany
city: Göttingen
country: Germany
city: Hannover
country: Germany
city: Homburg/saar
country: Germany
city: Köln
country: Germany
city: Muenchen
country: Germany
city: Muenchen
country: Germany
city: Muenster
country: Germany
city: Stuttgart
country: Germany
city: Tübingen
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: