Pilot study of bortezomib under rituximab standard therapy in patients with relapsed or refractory follicular lymphoma and at least 2 prior therapies
- Conditions
- 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: 9.1Level: LLTClassification code 10016904Term: Follicle centre lymphoma, follicular grade I, II, III NOS
- Registration Number
- EUCTR2005-003949-14-DE
- Lead Sponsor
- ORTHO BIOTECH, Geschäftsbereich der JANSSEN-CILAG GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of the efficacy and the safety of bortezomib in patients with relapsed or refractory follicular lymphoma under rituximab standard therapy<br><br>;Secondary Objective: ;Primary end point(s): Primary: - Time to progression or relapse.<br>Secondary: - Toxicities of bortezomib and rituximab <br> - CR-rate <br> - Disease-free survival <br> - Overall survival. <br>
- Secondary Outcome Measures
Name Time Method