Patients with histologically proven CD-20-positive follicular lymphoma grade I/II (WHO), stage III/IV (ANN ARBOR) relapsed or refractory to last treatment after at least 2 cytostatic therapies who are to be treated with rituximab therapy. MedDRA version: 9.1 Level: LLT Classification code 10016904 Term: Follicle centre lymphoma, follicular grade I, II, III NOS
Conditions
Sponsors
ORTHO BIOTECH, Geschäftsbereich der JANSSEN-CILAG GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged between 18 and 70 years 2. Histologically established, relapsed/refractory follicular CD-20-positive myeloma (grade I and 2), of stages III/IV (WHO) requiring treatment 3. Patients who are designed to be treated with rituximab after 2 or more cyto- static pretreatments 4. Existence of patient’s written informed consent 5. Women must be either post-menopausal for 2 years minimum, hysterectomized, or have had a tubal ligation; patients of childbearing potential must: a) use a safe method of contraception during treatment and for 12 months after completion (oral combination contraceptives, depot injections, implantates, IUDs hormonal IUD acting as a combination of mechanical and hormonal contra- ceptive), sexual abstinence, vasectomized partner) b) have a negative pregnancy test at time of screening 6. Male patients must use a reliable method of contraception during treatment and up to 12 months after completion. (Men who are planning to have children should be offered the option of sperm cryopreservation.) 7. Karnofsky status of 60% or more 8. AST (S-GOT) or ALT (S-GPT) less than 2.5 times the upper limit of normal 9. Total bilirubin less than 1.5 times the upper limit of normal 10. Adequate haematological functions: leukocytes 3.0 x 109/l or more neutrophils 1.5 x 109/l or more platelets 50 x 109/l or more 11. Creatinine less than 2 times the upper limit of normal Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of co-medication not allowed according to the SmPC 2. Previous treatment with bortezomib within the past 6 months before inclusion in the trial 3. Previous treatment with a combination of rituximab and bortezomib 4. Known allergic reaction to bortezomib, boron, or mannitol 5. Life expectancy of less than 3 months 6. Malignant neoplasia (except basalioma) within the past 5 years 7. Peripheral neuropathy of CTC grade 2 or more 8. Other severe comorbidities which, in the attending physician’s opinion, preclude involvement in the trial: a) Hepatic or renal insufficiency; clinically relevant pulmonary or gastrointestinal conditions b) Cardiac failure > NYHA II; myocardial infarction within 6 months prior to screening; pectoral angina; cardiac arrhythmia (more than Lown IVb); ECG evidence of acute ischaemia; conduction disorders; cardiac amyloidosis c) Systemic infection requiring treatment d) Poorly controlled hypertension or other clinically relevant vascular conditions e) Poorly controlled diabetes mellitus or other clinically relevant endocrine or meta- bolic conditions f) Pericardial disease g) Acute diffuse infiltrative pulmonal diseases 9. Hypotension (RRsys seated = 100 mmHg and/or RRdia seated = 60 mmHg) 10. HIV-positive patients 11. Active hepatitis B and/or hepatitis C 12. Pregnant or breastfeeding patients 13. Unwillingness or unability to cooperate; foreseeable problems with follow-up; psychiatric diseases; known current alcohol, drug, or substance abuse; legal incapacity 14. Concurrent involvement in other clinical trials, or involvement in another clinical trial within 30 days prior to inclusion in this trial; exceptions are drug examinations for the treatment of a relapse in the course of the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy and the safety of bortezomib in patients with relapsed or refractory follicular lymphoma under rituximab standard therapy ;Secondary Objective: ;Primary end point(s): Primary: - Time to progression or relapse. Secondary: - Toxicities of bortezomib and rituximab - CR-rate - Disease-free survival - Overall survival. | — |
Countries
Germany
Outcome results
None listed