A phase II multicentre trial of CVP, rituximab and gemcitabine for the treatment of patients with newly diagnosed diffuse large b-cell lymphoma considered unsuitable for r-chop chemotherapy - R-GCVP
- Conditions
- arge B cell non-Hodgkin’s lymphoma (DLBCL)
- Registration Number
- EUCTR2005-003888-23-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
a) Adequate contraceptive precautions if relevant.
b) Informed written consent.
c) No active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 5 years.
d) WHO performance status 0-3
e) Measurable disease
f) Age ³ 18 years.
g) Histologically proven diffuse large B cell non-Hodgkin’s lymphoma (DLBCL) according the current World Health Organisation classification14 including all morphological variants. The B cell nature of the proliferation must be verified by the positivity with an anti-CD20 antibody before randomisation. A central pathology panel will review all histology.
h) No previous chemotherapy, radiotherapy or other investigational drug for this indication.
i) Patients with a cardiac status that does not allow the administration of 8 courses of R-CHOP as defined by an ejection fraction of less than 50% either assessed by echocardiography or nuclear medicine examination [MUGA] or New York Heart Association classification Grade III or IV.
j) If the ejection fraction is >50% but there is evidence of other significant comorbities (i.e Hypertension, Diabetes Mellitus, Previous history of Ischaemic heart disease) that may contraindicate anthracylcine use, these patients may be considered for trial entry. In these circumstances you will be asked to document the comorbidities on the registration form.
k) Adequate bone marrow function as defined by: Platelets < 100x109/l; WBC < 3 x 109/l; Neutrophils < 1.5 x 109/l at the time of study entry unless attributed to bone marrow infiltration by lymphoma.
l) Serum bilirubin < 50 mmol/l and transaminases < 2.5´ upper limit of institutional normal range unless elevated level attributed to lymphoma.
m) Glomerular filtration rate >30ml/minute as assessed by urinary creatinine or Cockcroft-Gault Formula. If the GFR is 30-60ml/minute an EDTA 51Cr clearance should be performed.
n) No concurrent uncontrolled medical condition.
o) Life expectancy > 3 months.
p) Bulky stage IA (defined as lymph node or lymph node mass greater than 10cm in diameter), stage IB, stage II, stage III and stage IV.
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
a)Patients with symptomatic central nervous system or meningeal involvement by the lymphoma
b)Patients with a previous diagnosis high grade transformation of low grade lymphoma
c)Patients with stage IA disease
d)Patients with a positive serology for HIV or AIDS related lymphoma with a CD 4 count of <200.
e)Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
f)Pregnancy or breastfeeding.
g)ECOG performance status 4
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of the trial is evaluate the objective overall response rate of R-GCVP in patients with diffuse large B-cell non-Hodgkin’s lymphoma who cannot receive R-CHOP chemotherapy due to poor cardiac function, and to see whether it is sufficient for further investigation. ;Secondary Objective: ;<br> Primary end point(s): Primary Endpoint: Overall response rate<br><br> Secondary Endpoints: Toxicity<br> Progression free survival<br> Overall survival<br>
- Secondary Outcome Measures
Name Time Method