None listed
Conditions
Interventions
Group 1 Type of group
(VcR-CAP) Rituximab 375 mg / m2 intravenously (IV) on Day 1, Cyclophosphamide 750 mg / m2 IV on Day 1, Doxorubicin 50 mg / m2 IV on Day 1, VELCADE 1.3 mg / m2 (IV ) on Days 1, 4, 8 and 11, Prednisone 100 mg / m2 orally (PO) on Day 1 to Day 5 of a 21 day cycle (3 weeks) for 6 cycles.
Group name:Group 2 Type of group
(R-CHOP) Rituximab 375 mg / m2 intravenously (IV) on Day 1, Cyclophosphamide 750 mg / m2 IV on Day 1, Doxorubicin 50 mg / m ^ IV on Day 1, Vincristine 1.4 mg / m2 ( maximum total of 2 mg) IV on Day 1, Prednisone 100 mg / m2 orally (PO) on Day 1 to Day 5 of a 21-day cycle (3 weeks) for 6 cycles.
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Male or female patients 18 years of age or older • Diagnosis of MCL (Stage II, III or IV) evidenced by histology and; either cyclin DI expression (in association with CD20 and CD5) or evidence of t (11; 14), by cytogenetics, fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR). • At least 1 measurable site of illness. • No prior therapy for the MCL. • Not eligible for bone marrow transplantation as assessed by the attending physician (for example, the presence of comorbid conditions that may have a negative impact on the tolerability of the transplant). This should be checked with the sponsor´s study doctor. • Functional status 1500 cells / pL. • Platelets> 100,000 cells / ^ L. • Alanine transaminase 20 ml / min (Annex 2). • Women must be post-menopausal for at least 1 year (they must not have had a natural menstrual period for at least 12 months), surgically sterile, or are using an effective contraceptive method (eg, oral contraceptives by prescription, contraceptive injections, device intrauterine, double-barrier method, contraceptive patch, sterilization of the male partner) and have a serum p-hCG pregnancy test or a negative urine pregnancy test at preselection. • Men should agree to use an acceptable contraceptive method (for themselves or their female partners as indicated in the previous paragraph) throughout the study. • All patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of the study and the procedures required for the study and that they wish to participate in the study. • In order to participate in the pharmacogenomics component of this study, patients (or their legally acceptable representatives) must have signed the informed consent form for pharmacogenomic research indicating their desire to participate in the pharmacogenomics component of the study. Tumor samples are required for all patients (if they are available), all other sample collections are optional.
Exclusion criteria
Exclusion criteria: • Previous treatment with VELCADE • Antineoplastic therapy (including non-conjugated therapeutic antibodies), experimental or radiotherapy, radioimmunoconjugates or immunoconjugates with previous toxins for the treatment of MOL. In the event that a patient has received doxorubicin for the treatment of any disorder other than MOL, the maximum dose and exposure received prior to entering this study should not exceed 150 mg / m2. • Major surgery (at the discretion of the attending physician and in consultation with the sponsor´s medical monitor) within 2 weeks prior to randomization. • Peripheral neuropathy or neuropathic pain of Grade 2 or worse (based on the researcher´s evaluation). • Diagnosed or treated by another neoplasm that is not MCL within 1 year prior to randomization, or that has been previously diagnosed with a neoplasm that is not MCL and has any type of radiological evidence or biochemical markers of malignancy. Patients with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or malignancy in situ are not excluded • Active systemic infection that requires treatment. • History of allergic reaction attributable to compounds containing boron, mannitol or hydroxybenzoates. • Anaphylaxis or hypersensitivity mediated by immunoglobulin E (IgE) known to murine proteins or to any of the components of rituximab, including polysorbate 80 and sodium citrate dihydrate. • Female or male patients with reproductive potential who do not wish to use an adequate contraceptive method during the course of the study. • Serious medical or psychiatric illness that likely interferes with participation in this clinical trial. • Concurrent treatment with another agent in research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as the interval between the date of the randomization and the date of the PD or death, as reported before, in the population with intention to treat. Death due to EP will be considered an event if the date of death is within 6 months after the last evaluation of the disease (or within a period of evaluation of the disease); Measure:Free Survival of Progression (SLP) Timepoints:Interval between the date of the randomization and the date of the EP or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as the proportion of patients that achieve a CR, RCnc, or RP relative to the population according to the protocol. The response and progression of the disease will be evaluated according to the recommendations of the International Workshop to Standardize Response Criteria Group (IWRC) Measure:Global Response Index (GRI) Timepoints:At the end of the study ; Outcome name:Is defined as the proportion of patients that achieve a CR and RCnc relative to the population according to the protocol. The response and progression of the disease will be evaluated according to the recommendations of the International Workshop to Standardize Response Criteria Group (IWRC) (International Workshop to Standardize the Response Criteria) through radiographic imaging studies, physical examination and other procedures as necessary. Measure:CR index Timepoints:During the study ; Outcome name:Will be calculated from the date of the initial documentation of a response to the date of the first documented evidence of PD (or relapse for patients undergoing RC or RCnc in this study). Measure:The duration of the response (RC, RCnc, or RP) Timepoints:During the study ; Outcome name:It is defined as the duration from the date of randomization to the date of the first documented evidence of PE (or relapse for patients undergoing RC or RCnc in this study). Death due to PE will be considered an event if the date of death is within 6 months after the last evaluation of the disease. Measure:Time to Progression (THP) Timepoints:During the study ; Outcome name:Is measured from the date of randomization until the date of death of the patient. If the patient is alive or the vital state is unknown, the date of death will be counted on the date on which it is known for the last time that the patient was alive. Measure:Global Survival (GS) Timepoints:During and after the study | — |
Countries
Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Japan, Korea South, Malasya, Peru, Poland, Portugal, Russian Federation, Singapore, Spain, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed