A TWO-STAGE PHASE III, INTERNATIONAL, MULTI-CENTER, RANDOMIZED, CONTROLLED, OPEN-LABEL STUDY TO INVESTIGATE THE PHARMACOKINETICS, EFFICACY AND SAFETY OF RITUXIMAB SC IN COMBINATION WITH CHOP OR CVP VERSUS RITUXIMAB IV IN COMBINATION WITH CHOP OR CVP IN PATIENTS WITH PREVIOSLY UNTREATED FOLLICULAR LYMPHOMA FOLLOWED BY MAINTENANCE TREATMENT WITH EITHER RITUXIMB SC OR RITUXIMAB IV
- Registration Number
- PER-002-11
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 4
1. WRITTEN INFORMED CONSENT AND ABILITY AND WILLINGNESS TO COMPLY WITH THE VISIT SCHEDULE AND ASSESSMENTS REQUIRED BY THE PROTOCOL
2. AGE ≥ 18 YEARS
3. HISTOLOGICALLY CONFIRMED CD20-POSITIVE, FOLLICULAR NHL GRADE 1,2 OR 3A, ACCORDING TO THE WHO CLASSIFICATION SYSTEM. A TUMOR BIOPSY (LYMPH NODE, BONE MARROW, ETC.) MUST HAVE BEEN PERFORMED WITHIN 6 MONTHS BEFORE STUDY ENTRY WITH MATERIAL AVAILABLE FOR CENTRAL REVIEW
4. NO PRIOR TREATMENT. (NOTE THAT PATIENTS DIAGNOSED IN THE PAST WHO HAD BEEN ON WATCH AND WAIT” CAN ENTER THE TRIAL IF A TUMOR BIOPSY OBTAINED WITHIN THE LAST 6 MONTHS IS AVAILABLE FOR CENTRAL REVIEW)
5. PATIENTS WITH AT LEAST ONE OF THE FOLLOWING SIGNS AND SYMPTOMS REQUIRING TREATMENT:
A) BULKY DISEASE DEFINED AS A NODAL OR EXTRANODAL (EXCEPT SPLEEN) MASS ≥ 7 CM IN ITS GREATEST DIAMETER
B) B-SYMPTOMS
C) ELEVATED SERUM LDH OR Β2-MICROGLOBULIN
D) INVOLVEMENT OF AT LEAST 3 NODAL SITES (EACH WITH A DIAMETER GREATER THAN 3 CM)
E) SYMPTOMATIC SPLEEN ENLARGEMENT
F) COMPRESSIVE SYNDROME
G) PLEURA/PERITONEAL EFFUSION
6. ECOG PERFORMANCE STATUS OF O-2.
1. GRADE 3B FOLLICULAR LYMPHOMA
2. TRANSFORMATION TO HIGH-GRADE LYMPHOMA SECONDARY TO FOLLICULAR LYMPHOMA
3. TYPES OF NHL OTHER THAN FOLLICULAR LYMPHOMA ACCORDING TO THE WHO CLASSIFICATION
4. PRESENCE OR HISTORY OF CNS DISEASE (CNS LYMPHOMA OR LYMPHOMATOUS MENINGITIS)
5. CORTICOID THERAPY DURING THE LAST 4 WEEKS, UNLESS THE DOSE WAS BELOW 20 MG/DAY PREDNISONE EQUIVALENT
6. PRESENCE OR HISTORY OF MALIGNANCIES OTHER THAN FOLLICULAR LYMPHOMA. (PATIENTS WITH A HISTORY OF CURATIVELY TREATED BASAL OR SQUAMOUS CELL CARCINOMA OF THE SKIN, OR IN SITU CARCINOMA OF THE CERVIX, OR ANY OTHER CANCER FOR WHICH THE PATIENT HAS BEEN IN COMPLETE REMISSION FOR AT LEAST 5 YEARS ARE GENERALLY ELIGIBLE)
7. MAJOR SURGERY WITHIN 28 DAYS PRIOR TO STUDY ENTRY (LYMPH NODE BIOPSY IS N0T REGARDED TO BE A MAJOR SURGERY)
8. PREGNANCY OR NURSING FEMALES
9. FERTILE MEN OR WOMEN OF CHILDBEARING POTENTIAL UNLESS THEY AGREE TO USE EFFECTIVE CONTRACEPTION THROUGHOUT THE STUDY AND FOR AT LEAST 12 MONTHS AFTER THE LAST DOSE OF RITUXIMAB
10. ANY OF THE FOLLOWING ABNORMAL LABORATORY VALUES:
A) SERUM CREATININE >2 MG/DL (197 µMOL/L)
B) TOTAL BILIRUBIN > 1.5 TIMES THE UPPER LIMIT OF NORMAL
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method