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MabThera International Trial - MInT
Protocol Outline
| SPONSOR: | Hoffmann-La Roche AG, Basel |
| PROJECT PHASE: | IIIb |
| INDICATION: | Untreated diffuse large B-cell non-Hodgkin's lymphoma |
| OBJECTIVES: | To determine the safety and the efficacy of Rituximab antibody in patients with diffuse large B-cell non-Hodkin's lymphoma in combination with a standard CHOP-like chemotherapy regimen |
| STUDY DESIGN: | Phase-III, multicentre (intergroup)open-label, randomised trial |
| PLANNED SAMPLE SIZE: | 820 patients |
| NUMBER OF CENTERS: | Participating centres of the national cooperative groups which have been registered according to local government rules and have had the CRO initiation visit |
| PATIENT SELECTION CRITERIA: |
Male or female adult patients aged 18 to 60 years with untreated CD20-positive diffuse large B-cell non-Hodgkin´s lymphoma |
| STUDY MEDICATION: | Rituximab vials of 500 mg and 100 mg. The antibody will be given at a dosage of 375 mg/m2 i.v. every three weeks immediately preceding the CHOP-like chemotherapy regimen. |
| COMPARATOR: | CHOP-like chemotherapy without rituximab |
| MAIN PARAMETERS OF EFFICACY: | TTTF (time to treatment failure): primary end point; secondary end points: complete remission rate, survival, tumour control, disease-free survival, progression rate. |
| MAIN PARAMETERS OF SAFETY: | Adverse events, serious adverse events. |
| STUDY PROCEDURE: | Patients are randomly assigned to receive CHOP-like chemotherapy with or without the anti-CD20 antibody Rituximab. Patients with primary bulky disease or extranodal involvement are eligible to receive additional involved-field radiotherapy with 30-40 Gy to these areas . |
| STATISTICAL ANALYSIS: | The two treatment arms will be compared for time to treatment failure (TTTF) by log-rank test. |
| DURATION OF THE STUDY | The trial will start in March 2000. Based on an expected recruitment of 400 patients per year, 820 patients will be randomised within a period of approx. two years. The minimum follow-up time after the end of the recruitment period will be 3 years, with a total study period of 5 years. |