Status:
COMPLETED
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hod...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;
- patients who have received adequate (\>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease;
- demonstrated partial or complete response to induction therapy.
Exclusion
- stable or progressive disease after most recent induction therapy;
- transformation to high grade lymphoma;
- patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.
Key Trial Info
Start Date :
September 4 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2011
Estimated Enrollment :
545 Patients enrolled
Trial Details
Trial ID
NCT00430352
Start Date
September 4 2006
End Date
May 26 2011
Last Update
August 14 2017
Active Locations (178)
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1
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, Albania, 1000
2
Instituo Lavalle de Oncologia; Hematology
Bahía Blanca, Argentina, 8001
3
Academia Nacional de Medicina; Inst. de Cardiologia
Buenos Aires, Argentina, 1425
4
Fundaleu; Haematology
Buenos Aires, Argentina, C1114AAN