A phase II multicenter open-label study of MabThera (Rituximab) addition to regularly prescribed chemotherapy in patients with untreated Mantle Cell Lymphoma
- Conditions
- Mantle Cell LymphomaMedDRA version: 19.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2009-011433-27-RO
- Lead Sponsor
- Roche Romania SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1.Histologically confirmed mantle cell lymphoma (MCL) according to WHO classification prior to study inclusion. The diagnosis has to be confirmed by immunophenotyping CD 20+ (CD5+, CD23-, sIgM, cyclin D1, Ki 67 )
2.At least 1 measurable or assessable site of disease; in case of bone marrow infiltration only, bone marrow aspiration/ biospy is mandatory for all staging evaluations
3.Patients with untreated MCL (excepting radiotherapy used for palliative, not for curative purposes) at any stage requiring therapy in the opinion of the treating physician that are not eligible for Autologous Stem Cell Transplant.
4.Age >18 years old
5.ECOG PS 0-2
6.Life expectancy >6 months
7.Known MIPI at the time of diagnosis
8.Women of child bearing potential must have negative pregnancy test and agree to use effective contraception during entire study therapy and 12 months thereafter; men must agree not to father a child during entire study therapy and 12 months thereafter
9.Adequate hematological function within 28 days prior to the first rituximab infusion:
•Haemoglobin= 8 g/dL
•Absolute neutrophile count =1.5x109/L
•Platelet count=100x109/L
10.Adequate hepatic and renal function:
•Transaminases (ASAT and ALAT) =3 x upper limit of normal (ULN)
•Total bilirubin =2 x ULN
•Alkaline phosphatase =2 x ULN
•Creatinine =2 mg/dL or calculated creatinine clearance =50 mL/min
11.LVEF=50 %
12.Patients willing and able to comply to study protocol for the entire study duration
13.Patient’s written informed consent
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1.Known hypersensitivity to murine proteins or chemotherapy regimen
2.Previous first line therapy
3.History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma within the last 5 years
4.Active opportunistic infections requiring treatment
5.Active HIV infection, hepatitis B or C
6.Serious underlying conditions which could impair the patient ability to take part in the study (uncontrolled diabetes mellitus, severe cardiac dysfunction or angina, gastric ulcer, pulmonary, endocrinological or neurological disorder, psychiatric illness, active autoimmune disease)
7.Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary disease or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
8.Pregnancy and lactation
9.Creatinine clearance =30 mL/min
10.Major surgery other than diagnostic surgery within 28 days prior to study entry
11.Patients regularly taking corticosteroids during the last 4 weeks
12.Treatment within a clinical trial within 30 days before study entry
13.Patients unable to comply to study protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine Overall Response Rate(ORR) (expressed as CR and PR) in MCL patients treated with MabThera plus chemotherapy;Secondary Objective: To determine Overall Survival(OS), Progression Free Survival (PFS) and toxicity of the treatment and to identify predictive factors for a positive prognosis.;Primary end point(s): To determine Overall Response Rate(ORR) (expressed as CR and PR) in MCL patients treated with MabThera<br>plus chemotherapy;Timepoint(s) of evaluation of this end point: no
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To determine Overall Survival(OS), Progression Free Survival (PFS) and toxicity of the treatment and to identify<br>predictive factors for a positive prognosis.;Timepoint(s) of evaluation of this end point: no