Diffuse large B cell lymphoma (DLBCL) MedDRA version: 14.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: VELCADE
Product Name: BORTEZOMIB
Product Code: PR-1
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Other descriptive name: P
Sponsors
GELTAMO (Grupo Cooperativo Español de Linfoma/Trasplante Autólogo de Médula Ósea)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.- Patients diagnosed with primary diffuse DLBCL who have never received treatment for this condition. 2.- Age between 18 and 70 years. 3.- Age adjusted IPI higher than 1 or equal 1, with high levels of beta-2-microglobulin (above UNL) 4.- Neoplasic B lymphocytes for CD20 positivity. 5.- ECOG 0-3 6.- More than 12 weeks of life expectancy. 7.- Signed Informed Consent. 8.- Nor pregnant women nor breast-feeding women without heterosexual activity during the entire study. Women with heterosexual activity only if they are willing to use two methods of contraceptive. The two contraceptive methods can be, two barrier method or a barrier method combinated with an hormonal contraceptive method to prevent pregnancy, used during the entire study and until 3 months after the study completion. 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 127 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 127
Exclusion criteria
Exclusion criteria: 1. Pregnant women or in breast-feeding period, or adults in childbearing period not using an effective contraception method. 2. Patients with CNS lymphoma 3. Patients with severe impairment of renal function (creatinine> 2.5 UNL) or hepatic (bilirubin or ALT / AST> 3 UNL), unless it is suspected to be due to the disease. 4. HIV positive patients 5. Patient previously treated for the DLBCL 6. Positive determination of chronic hepatitis B (defined as positive serology for HBsAg). It will be allowed to enroll patients with hidden or previuos hepatitis (defined as positive antibodies against the core of the hepatitis B virus [HBcAb] and HBsAg negative) if undetectable HBV DNA. 7. Positive results for hepatitis C (antibody serology for hepatitis C virus [HCV]). Patients with HCV positive may participate only if the result of the PCR is negative for HCV RNA. 8.Patients with previous history of cardiac disease: ventricular ejection fraction < 50%. 9. Patients with severe psiquiatric conditions that may interfere with their ability to understand the study (including alcoholism or drug addiction). 10. Patients with known hypersensitivity to murine proteins or any other component of the study drugs. 11. Transformed follicular lymphoma. 12. History of other primary malignancy with < 5 year of complete response (except for basal or squamous cell carcinomas of the skin or cervical carcinoma in situ). 13. Uncontrolled current illness: cardiac, pulmonary, neurologic, metabolic etc, not related to lymphoma. 14. Uncontrolled hypertension (diastolic blood pressure over 110 mmHg). 15. Psychiatric illnesses that could compromise the patient participation in the study. 16. Known or suspected hypersensitivity to any of the agents of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the proportion of patients with event-free survival at 2 years in patients diagnosed of DLBCL with aIPI > 1 or aIPI=1 with elevated levels of beta 2-mcroglobulin (above UNL). UNL= Upper Normal Limit. ;Secondary Objective: 1. Event -free survival at 2 years in differents biological DLBCL subgroups: CGB vs non-CGB. 2. Overall survival at 2 years in patients diagnosed of DLBCL with aIPI > 1 or aIPI=1 with elevated levels of beta 2-microglobulin (above UNL). 3. Overall response rate and complete remissions in patients diagnosed of DLBCL with aIPI > 1 or aIPI=1 with elevated levels of beta 2-mcroglobulin (above UNL). 4. Toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI). http://ctep.cancer.gov/reporting/ctcnew.html) 5. To evaluate the predictive value for EFS of interim PET/CT evaluation after 2 and 4 cycles of chemotherapy. 6. To identify clinical and biological prognostic factors for response and survival.;Primary end point(s): Propotion of patients with event -free survival at 2 years.;Timepoint(s) of evaluation of this end point: Once the treatment is started, there will be weekly safety visits, visits before each treatment cycle, at day 60 after the sixth cycle and then follow-up visits every three months during the first 2 years and every 6 months until the 5th year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Event -free survival at 2 years. - Overal survival at 2 years. - Complete remission rate. - Complete remision rate not documented/not confirmed. - Partial remission rate. - Stable Disease rate, progression. - Relapsed Disease rate. - Proportion of subjects who have received all planned chemotherapy dose on schedule. - Proportion of cycles of chemotherapy administered in planned doses and on schedule. - Clinical predictors factors of response. - Safety endpoints from cycle 1 to 6. - Prognostic value of PET in terms of survival. - Biological prognostic factors, including histologic subtype CGB vs non-CGB.;Timepoint(s) of evaluation of this end point: Once the treatment is started, there will be weekly safety visits, a visit before each treatment cycle, a visit at day 60 after the sixth cycle and then follow-up visits every three months the first 2 years and every 6 months until the 5th year. | — |
Countries
Spain
Contacts
Public ContactÁngel Cedillo
Secretaría Científica GELTAMO
Outcome results
None listed