None listed
Conditions
Interventions
THE PRIMARY EFFICACY ENDPOINT IS CR/CRU 4 TO 8 WEEKS AFTER THE END OF TREATMENT ACCORDING TO THE ORIGINAL VERSION OF THE RESPONSE CRITERIA FOR MALIGNANT LYMPHOMA (CHESON 1999
SEE APPENDIX 2). THE TRIAL WILL BE CONDUCTED AL APPROXIMATELY 170 CENTRES WORLDWIDE.
ALL POTENCIAL STUDY PATIENTS MUST PROVIDE SIGNED WRITTEN INFORMED CONSENT (APPROVED BY THE RELEVANT INDEPENDENT
60 YEARS), IPI RISK CATEGORY (LOW, LOW-INTERMEDIATE, HIGH), AND CHEMOTHERAPY REGIMEN (CHOP-21, CHOP-14), WHICH WILL BE SELECTED BY THE INVESTIGATOR PRIOR TO RANDOMIZATION.
STUDY TREATMENT IN BOTH
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. SIGNED, WRITTEN INFORMED CONSENT FORM 2. AGE ≥ 18 AND ≤ 80 YEARS AT TIME OF STUDY INCLUSION 3. HISTOLOGICALLY CONFIRMED, PREVIOUSLY UNTREATED CD20-POSITIVE DLBCL ACCORDING TO THE WHO CLASSIFICATION SYSTEM 4. PATIENTS WITH AN IPI SCORE OF 1-5 OR IPI SCORE OF 0 WITH BULKY DISEASE, DEFINED AS ONE LESION ≥ 7.5 CM 5. AT LEAST ONE BI-DIMENSIONALLY MEASURABLE LESION DEFINED AS ≥ 1.5 CM IN ITS LARGEST DIMENSION ON CT SCAN 6. ADEQUATE HAEMATOLOGIC FUNCTION, DEFINED AS FOLLOWS: . HAEMOGLOBIN ≥ 9 G/DL (NOTE: NO TRANSFUSIONS ALLOWED WITHIN 2 WEEKS PRIOR TO THE START OF STUDY DRUG ADMINISTRATION) . ABSOLUTE NEUTROPHIL COUNT (ANC) ≥ 1.5 X 109/L . PLATELET COUNT ≥ 75 X 109/L NOTE: ABNORMALITIES OUTSIDE THE ABOVE LISTED ARE ALLOWED IF RELATED TO INVOLVEMENT OF BONE MARROW BY THE UNDERLYING DISEASE. 7. EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS ≤ 2. 8. AGREEMENT TO USE ADEQUATE CONTRACEPTION DURING THE STUDY TREATMENT PERIOD AND FOR AT LEAST 12 MONTHS AFTER THE LAST DOSE OF STUDY DRUG:
Exclusion criteria
Exclusion criteria: CANCER RELATED CRITERIA 1. PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, BLASTIC VARIANT OF MANTLE CELL LYMPHOMA, OR HISTOLOGIC EVIDENCE OF TRANSFORMATION TO BURKITT LYMPHOMA, PRIMARY MEDIASTINAL DLBCL, PRIMARY EFFUSION LYMPHOMA, PRIMARY CUTANEOUS DLBCL, OR PRIMARY DLBCL OF THE TESTIS 2. TRANSFORMED LYMPHOMA OR FOLLICULAR LYMPHOMA IIIB 3. PRIOR THERAPY FOR DLBCL, WITH THE EXCEPTION OF NODAL BIOPSY OR LOCAL IRRADIATION 4. HISTORY OF OTHER MALIGNANCY, EXCEPT: - PATIENTS WITH CURATIVELY TREATED BASAL OR SQUAMOUS CELL CARCINOMA OR MELANOMA OF THE SKIN OR IN SITU CARCINOMA OF THE CERVIX ARE ELIGIBLE; - A MALIGNANCY THAT HAS BEEN TREATED BUT NOT WITH CURATIVE INTENT WILL BE EXCLUDED, UNLESS THE MALIGNANCY HAS BEEN IN REMISSION WITHOUT TREATMENT FOR 5 YEARS PRIOR TO ENROLMENT. BIOCHEMICAL AND ORGAN FUNCTION RELATED CRITERIA 5. INADEQUATE RENAL FUNCTION, DEFINED AS CREATININE > 1.5 TIMES THE UPPER LIMIT OF NORMAL (ULN) (UNLESS CREATININE CLEARANCE [CRCI] NORMAL), OR CALCULATED CRA 2.5 X THE ULN
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Colombia, Finland, France, Greece, India, Ireland, Israel, Italy, Netherlands, Peru, Poland, Portugal, Russian Federation, South Africa, Spain, Thailand, Turkey, Ukraine, United Kindgdom, Venezuela
Contacts
Public ContactHedwig Schmidt
ROCHE FARMA (PERU) S.A.
Outcome results
None listed